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Monday, February 4
 

14:00

SC01: Short Course 1: Benefit-Risk Management Methodologies
Component Type: Tutorial

Although several approaches for qualitative and quantitative benefit-risk management have been discussed for several years, their application in everyday practice remains scarce. This is particularly astonishing as with the move of PSURs to the PBRER-format, a systematic evaluation of the Benefit-Risk profile of every drug should be performed. This course aims to provide an opportunity to explore different methods in order to foster a more frequent and systematic utilization of methods enhancing the transparency around Benefit-Risk decision making. We will introduce methods for the analysis of risk factors contributing to the development of (potential) risks (Zurich Hazard Analysis, Fault Tree Analysis), the analysis of risks associated with medication processes leading to potential medication errors (Failure Modes and Effects Analysis), Qualitative Benefit-Risk frameworks, as well as discuss the possible uses for Quantitative Benefit-Risk analysis methods. Suitable examples for all methods will be used to show the strengths as well as the limitations of the methodologies discussed.

Who should attend?

Primary audience is in Clinical Safety/Pharmacovigilance with experience in risk management planning and execution.. Also for professionals working in Clinical Research, Research & Development, Regulatory Affairs and/or Quality Assurance/Quality Control.

Learning Objectives

Understand the relative advantages/disadvantages of different methods in (benefit)-risk management in order to apply the most suitable approach for a given situation Get basic experience in the hands-on performance of various types of benefit-risk analyses to be able to critically evaluate results from such exercises Learn how to use the results from such analyses in Benefit-Risk communication


Speakers
avatar for Michael Forstner

Michael Forstner

Senior Vice President, Head of Risk Management and Pharmacoepidemiology, PrimeVigilance
Michael's main focus areas are the planning, development, implementation and evaluation of benefit-risk management solutions, as well as the optimization of processes around benefit-risk management. He is engaged in developing and applying (benefit-) risk analysis methodologies in... Read More →


Monday February 4, 2019 14:00 - 17:30
  • Featured Topics Pharmacovigilance
  • Tags Tutorial

14:00

SC02: Short Course 2: European Regulatory Meetings – How to Best Prepare and Perform
Component Type: Tutorial

High stakes meetings such as CHMP/PRAC oral explanations are often the ultimate chance for a pharmaceutical sponsor to convince EU regulators that the benefit/risk balance of their product is positive. Being well prepared and performing professional is key to success. This short course focuses on how best to plan, manage, prepare and execute successfully at EU high stakes meetings. Former CHMP members, pharma executives and communication specialists will walk you through the key steps in preparing as well as the “do’s and don’ts” when presenting and engaging with EU regulators. Focus will be on CHMP oral explanation but the learnings will be applicable to all other EU regulatory oral interactions. We will discuss how best to present your key massages and supporting slides and manuscript. How to develop a Q&A grid in collaboration with your team and how best to manage back up slides when responding to questions will be part of the learnings. How best to deal with practicalities and logistics around a CHMP oral explanation in order to minimise the stress on your team will also be touch upon. The course will include anonymized examples from real or imagined meetings and enable the participants to better understand the process and its challenges as well as how best to cope with these.

Who should attend?

Regulatory affairs professionals involved in EU centralised MAAs, pharmacovigilance or scientific advice

Learning Objectives

Plan, manage, prepare and execute successfully at EU high stakes meetings


Speakers
avatar for Lisa Peluso

Lisa Peluso

Director, Coaching and Client Engagement, PharmApprove, a member of the NDA Group
Lisa helps development teams to create and deliver clear, consistent, and convincing messages to critical audiences and decision-makers. She has coached hundreds of individuals and provided presentation, Q&A and facilitation training to teams in pharma, and biotech, and has helped... Read More →
avatar for Steffen Thirstrup

Steffen Thirstrup

Director, NDA Regulatory Advisory Board, NDA Advisory Services Ltd
Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor in pharmacotherapy at the Faculty of Health Sciences... Read More →


Monday February 4, 2019 14:00 - 17:30
  • Featured Topics Regulatory Science
  • Tags Tutorial
 
Tuesday, February 5
 

10:00

#KN1: Opening Plenary: Patient Experience, Empowerment, Engagement: A Business Leader’s View
Component Type: Session



Speaker

Patient Experience, Empowerment, Engagement: A Business Leader’s View
Dave deBronkart



Speakers
avatar for Dave deBronkart

Dave deBronkart

Speaker, e-Patient Dave
Dave deBronkart is a cancer survivor and former high tech marketer, who serves on the BMJ patient advisory panel. He was Mayo’s 2015 Visiting Professor in Internal Medicine, and advises on branding and product from the patient perspective.Author of books and numerous articles in... Read More →


Tuesday February 5, 2019 10:00 - 10:45
Hall D Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Patient Engagement
  • Tags Session

11:00

#DMD1: European Regulatory Town Hall Meeting – Key Topics for the Future
Component Type: Session

• Status of telematic implementation • Timely access to medicine • Availability of medicinal products • First look at ideas for Strategy 2021 – 2025

Chair

Christa Wirthumer-Hoche, PhD

Speaker

Panel Discussion
Nicola Bedlington

Panel Discussion
Karl Broich, DrMed

Panel Discussion
Nathalie Moll

Panel Discussion
Guido Rasi, MD

Panel Discussion
Thomas Senderovitz, DrMed, MD



Speakers
avatar for Karl Broich

Karl Broich

President, Federal Institute for Drugs and Medical Devices (BfArM)
Physician, MD (certifications in Neurology, Psychiatry, Behavioural Psychotherapy). BfArM in Bonn (Germany): 2000 to 2014 several executive functions, since 08/2014 head (President). Work in several EMA committees; chair of CNS-Working Party. Current research: clinical trials methodology... Read More →
avatar for Harald Enzmann

Harald Enzmann

Chair, CHMP; Head of European and International Affairs, Federal Institute for Drugs and Medical Devices (BfArM)
Harald Enzmann is chairperson of EMA’s Committee for Medicinal Products for Human Use (CHMP). A physician by training, Harald held positions at the German Cancer Research Center (dkfz), at the Intitute of Pharmacology and Toxicology at the University of Erlangen, at R&D at Bayer... Read More →
NM

Nathalie Moll

Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA)
avatar for Guido Rasi

Guido Rasi

Executive Director, European Medicines Agency (EMA)
Prof Guido Rasi began his second term as Executive Director of EMA on 16 November 2015. From November 2014 to mid-November 2015, he served as EMA’s Principal Adviser in Charge of Strategy. From November 2011 to November 2014 he was the Executive Director of the EMA and a member... Read More →
avatar for Thomas Senderovitz

Thomas Senderovitz

Chair of HMA Management Group; Director General, Danish Medicines Agency
Thomas Senderovitz took over as Director General of the Danish Medicines Agency on 1 April 2016. His career includes more than 20 years working with medicinal products and he has held several senior positions in international biopharmaceutical Companies. He previously worked at the... Read More →
avatar for Christa Wirthumer-Hoche

Christa Wirthumer-Hoche

Chair, EMA Management Board, Head, Austrian Medicines and Medical Devices Agency
Christa Wirthumer-Hoche studied biochemistry TU Vienna, doctoral thesis at Medical Physiology. Starting at the AT Nat. Inst. for Quality Control of Drugs - quality assessment, Head of Regulatory Affairs in the Ministry of Health, Now Head of the Austrian Medicines and Medical Devices... Read More →
avatar for Nicola Bedlington

Nicola Bedlington

Secretary General, European Patient's Forum
Nicola Bedlington was first Executive Director of the European Patients’ Forum (EUPATI), which she continues to serve as its Secretary General, and is co-founder of Patients Access Partnership (PACT). She previously provided leadership to the Swiss government’s Environment and... Read More →


Tuesday February 5, 2019 11:00 - 12:30
Hall D Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Regulatory Science
  • Tags Session

11:00

#DMD6: Real World Data: How to Deliver its Potential to Support Innovation
Component Type: Session

Real World Data (RWD) has the potential to support getting products to patients with unmet needs. It is already supporting key decisions by regulators, HTA bodies, payers and industry but the opportunity for even better use of RWD is huge. This session draws on the expertise of some of the most experienced global experts and through TED-style talks and debate will look at how this opportunity can be realised in Europe.

Chair

Daniel Morales, MD, PhD, MRCP

Speaker

How Industry is Delivering Innovation through Real World Data
Ryan Dean Kilpatrick, PhD

Confidence in Real World Data
Sebastian Schneeweiss, DrSc, MD, MS, FISPE

How a Common Data Model Can Support Innovation
Peter Rijnbeek, PhD

Collaboration between Data Owners to Deliver Quality Data and Robust Analysis
Miriam Sturkenboom, PhD, MPharm, MSc, FISPE



Speakers
RK

Ryan Kilpatrick

Global Head, Epidemiology, AbbVie
Ryan Kilpatrick is the head of epidemiology at AbbVie, Inc. Prior to this, he held roles in Amgen, GSK and Baxalta. His primary interest is in use of pharmacoepidemiology in drug safety and to support drug development across the product lifecycle.
avatar for Daniel Morales

Daniel Morales

Member PRAC, Pharmacovigilance and Epidemiology Department, University of Dundee
Daniel Morales is a General Practitioner and Epidemiologist at the University of Dundee and current member of the EMA Pharmacovigilance Risk Assessment Committee. His research interests include the use of real world data to support medicines regulation and safer prescribing, and has... Read More →
avatar for Peter Rijnbeek

Peter Rijnbeek

Assistant Professor Medical Informatics, Erasmus Medical Center
Peter Rijnbeek is Assistant Professor at the Erasmus University Medical Center in Rotterdam where he is leading the Health Data Science group at the Department of Medical Informatics (www.healthdatascience.nl). He is co-leading the European Health Data and Evidence Network (EHDEN... Read More →
avatar for Sebastian Schneeweiss

Sebastian Schneeweiss

Professor of Medicine and Epidemiology, Harvard Medical School and Brigham & Women's Hospital
Sebastian Schneeweiss, MD, ScD, is a Professor of Medicine and Epidemiology at Harvard Medical School and Chief of the Division of Pharmacoepidemiology, Department of Medicine, Brigham and Women’s Hospital. His research focuses on the comparative effectiveness and safety of biopharmaceuticals... Read More →
avatar for Miriam Sturkenboom

Miriam Sturkenboom

Professor, Julius Global Health, University Medical Center Utrecht
Miriam Sturkenboom is a professor in Observational Data Analysis, a pharmacoepidemiologist, currently working at the Julius Global Health group of University Medical Center Utrecht in the Netherlands. She is a past president of ISPE. Her research focuses on knowledge discovery from... Read More →


Tuesday February 5, 2019 11:00 - 12:30
E1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Clinical Development ,Pharmacovigilance,Data and Data Standards
  • Tags Session

12:30

#PS01: Oral Poster Session 1 - Translational Medicines and Science & Data and Data Standards Content Hub
Component Type: Session



Speaker

Human milk collection method, challenges, and lessons learned in a multicenter nutritional study
Amelie Goyer, PhD, PMP

How common are claims on the association between the onset of autism and drug exposure: a systematic review
Lindsay Kadjidja, MSc



Speakers
AG

Amelie Goyer

Clinical Project Manager, Nestec Ltd.
LK

Lindsay Kadjidja

Student, Institut De Pharmacie Industrielle De Lyon


Tuesday February 5, 2019 12:30 - 13:00
Content Hub 3 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

12:30

#L1: Lunch in the Exhibition Hall
Component Type: Social Event




Tuesday February 5, 2019 12:30 - 14:00
Exhibition Hall Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

13:30

#CHS02: Beyond Translation in the Centralised Procedure: Reducing the administrative burden of the linguistic review process
Component Type: Session



Chair

Ben Rainforth


Tuesday February 5, 2019 13:30 - 14:00
Content Hub 4 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

13:30

#PS02: Oral Poster Session 2 - Clinical Development & Pharmacovigilance Content Hub
Component Type: Session



Speaker

Considerations for outsourcing EU QPPV services taking into account the impact of Brexit
Kosta Cvijovic, PhD, MPharm

Internal Safety Advisory Groups (ISAG): A Win-Win for Effective Decision-Making in Biopharmaceutical Companies
Eric Cohen, DrMed

CAST analysis of UK pregnancies reported after isotretinoin administration
Brian Edwards, DrMed



Speakers
EC

Eric Cohen

Medical Director, Abbvie
KC

Kosta Cvijovic

EU QPPV, Syneos Health
avatar for Brian Edwards

Brian Edwards

Principal Consultant, Pharmacovigilance and Drug Safety, Vice-President ACRES, NDA Group
After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining... Read More →


Tuesday February 5, 2019 13:30 - 14:00
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

14:00

#DMD3: Patient Engagement as a Strategic Imperative in Therapeutic Innovation
Component Type: Session

Patient engagement remains very much in vogue, but does it really make a difference? This session will look at why patient engagement matters to different stakeholders in the value chain of medicines. We will explore patient engagement strategies within various institutions, organisations and companies - and the kind of buy-in needed from different stakeholders (patient organisations, industry, regulators, policy makers, HCPs) involved in making patient engagement happen across the entire life cycle. We will look candidly at some of the challenges of patient engagement and if we are where we need to be as we move towards the next decade of the 21st century. • A Brief History – The roots of patient engagement • Key Pillars of the IMI Patient Engagement Strategy • Prioritising Patient Engagement at the EMA and Looking to the Future • Transforming a Major Pharma towards Patient Engagement

Chair

Nicola Bedlington

Speaker

Panel Discussion
Dimitrios Athanasiou, MBA

Panel Discussion
Pierre Meulien, PhD

Panel Discussion
Guido Rasi, MD



Speakers
avatar for Dimitrios Athanasiou

Dimitrios Athanasiou

Patient Advocate, WORLD DUCHENNE ORGANIZATION (WDO) , MDA HELLAS
Dimitrios Athanasiou is a PDCO member representing EURORDIS. He holds a BA and an MBA in Financial Management He attended Eurordis Summer School and European Patient Academy (EUPATI) acquiring basic biotech and regulatory knowledge. As a full time patient advocate in DMD, he is a... Read More →
avatar for Nicola Bedlington

Nicola Bedlington

Secretary General, European Patient's Forum
Nicola Bedlington was first Executive Director of the European Patients’ Forum (EUPATI), which she continues to serve as its Secretary General, and is co-founder of Patients Access Partnership (PACT). She previously provided leadership to the Swiss government’s Environment and... Read More →
avatar for Pierre Meulien

Pierre Meulien

Executive Director, Innovative Medicines Initiative (IMI)
Pierre Meulien is executive director of the Innovative Medicines Initiative (IMI), a €5 billion public-private partnership between the European Union and the European pharmaceutical industry. At IMI, he is responsible for the overall management of the program, which works to improve... Read More →
avatar for Guido Rasi

Guido Rasi

Executive Director, European Medicines Agency (EMA)
Prof Guido Rasi began his second term as Executive Director of EMA on 16 November 2015. From November 2014 to mid-November 2015, he served as EMA’s Principal Adviser in Charge of Strategy. From November 2011 to November 2014 he was the Executive Director of the EMA and a member... Read More →


Tuesday February 5, 2019 14:00 - 15:15
E1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Patient Engagement
  • Tags Session

14:00

#DMD4: EUnetHTA Town Hall: Impact of Health Technology Assessment when Evidence (Regulatory vs Relative), Costs and Patient Expectations are Challenging to Combine
Component Type: Session



Chair

Niklas Hedberg, MPharm

Speaker

Regulator Perspective
Marie Gardmark

Payer Perspective
Robert Sauermann

Industry Perspective
Adam Parnaby



Speakers
avatar for Marie Gardmark

Marie Gardmark

Head of Licensing, Swedish Medicines Agency (MPA)
avatar for Niklas Hedberg

Niklas Hedberg

Chair EUnetHTA Executive Board, Chief Pharmacist, Dental and Pharmaceutical Benefits Agency, TLV
Niklas Hedberg, MSc, is Chief Pharmacist for the Dental and Pharmaceuticals Benefits Agency (TLV) in Sweden. He is also Chair of the EUnetHTA Executive Board, TLV’s lead partner in EUnetHTA, and has led EUnetHTA WP3 – Evaluation since 2016. Mr. Hedberg has broad experience in... Read More →
avatar for Adam Parnaby

Adam Parnaby

Senior Director Market Access Policy, Worldwide Markets, Celgene
Adam has 18 years of experience in the pharma industry and started his career as an academic health economist. Previously, he was Director of Pricing and Market Access for Celgene’s Oncology portfolio in the EMEA region. Prior to joining Celgene, he worked in Health Economics and... Read More →
avatar for Bettina Ryll

Bettina Ryll

Chair ESMO Patient Advocates Working Group (PAWG), Melanoma Patients
Bettina Ryll, MD/PhD founded the Melanoma Patient Network Europe in 2013 and developed a special interest in patient-centric clinical research and drug development. Bettina’s current areas of focus are Adaptive Licensing/ MAPPS , innovative sustainable healthcare models and patient-centered... Read More →
RS

Robert Sauermann

Department Head, Association of Austrian Social Insurance


Tuesday February 5, 2019 14:00 - 15:15
E2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Value and Access
  • Tags Session

14:00

#SAT1: WHO Signature Session: Putting Reliance into Practice: WHO’s Activities on Regulatory Systems Strengthening
Component Type: Session

Session in development

Chair

Emer Cooke, MBA, MSc

Speaker

Opening Keynote
Mike Ward

Experience from European System – A Model for LMICs
Thomas Senderovitz, DrMed, MD

Panelist
Virginia Lee Acha, PhD, MSc

Panelist
Petra Doerr, PharmD, RPh



Speakers
avatar for Virginia Acha

Virginia Acha

Executive Director, Global Regulatory Policy, MSD
Virginia (Ginny) has worked in industry and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She recently joined MSD to lead regulatory policy efforts for innovation that will lead to better... Read More →
avatar for Emer Cooke

Emer Cooke

Director of Regulation of Medicines and other Health Technologies, World Health Organization (WHO)
Ms. Cooke holds a MSc in Pharmaceutical Chemistry and an MBA from Trinity College, Dublin. Emer joined EMA as Head of Inspections in Jul. 2002. In Jan. 2009, Emer was appointed first International Liaison Officer for EMA. In July 2012 becomes the Head of Int. and European Cooperation... Read More →
avatar for Petra Doerr

Petra Doerr

Deputy Executive Director, Swissmedic
Since January 2014 Head of Communication and Networking and Deputy Executive Director at Swissmedic, Swiss Agency for Therapeutic Products. Oversees the international cooperation with other agencies and international organisations. Member of the ICH Management Committee & Vice-chair... Read More →
avatar for Thomas Senderovitz

Thomas Senderovitz

Chair of HMA Management Group; Director General, Danish Medicines Agency
Thomas Senderovitz took over as Director General of the Danish Medicines Agency on 1 April 2016. His career includes more than 20 years working with medicinal products and he has held several senior positions in international biopharmaceutical Companies. He previously worked at the... Read More →
avatar for Mike Ward

Mike Ward

Coordinator, Regulatory Systems Strengthening, EMP, World Health Organization (WHO)
Mike Ward is Coordinator of the Regulatory System Strengthening Team, Department of Essential Medicines and Health Technologies, Health Systems and Innovation Cluster, WHO Headquarters; he joined WHO as the Coordinator, Prequalification Team, in this same Department. He previously... Read More →


Tuesday February 5, 2019 14:00 - 15:15
DIAlogue Space Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Regulatory Science
  • Tags Session

15:15

#CB1: Coffee Break in the Exhibition Hall
Component Type: Social Event




Tuesday February 5, 2019 15:15 - 16:00
Exhibition Hall Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

15:30

#CHS04: Accelerating Clinical Study Start Up with Innovative Technologies
Component Type: Session



Chair

Evi Cohen, MBA, MS


Speakers
avatar for Evi Cohen

Evi Cohen

Vice President, Global Life Sciences and Healthcare, Appian


Tuesday February 5, 2019 15:30 - 16:00
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

15:30

#PS03: Oral Poster Session 3 - Patient Engagement & Medical Affairs Content Hub
Component Type: Session



Speaker

Moving beyond peer-review: What healthcare providers across various specialties say they value in scientific publications
Cynthia Nediyakalayil, PharmD, MBA

Convergence in OTC drug regulations
Toshiyoshi Tominaga, PhD



Speakers
CN

Cynthia Nediyakalayil

Medical Affairs - External Scientific Communications, Allergan
avatar for Toshiyoshi Tominaga

Toshiyoshi Tominaga

Senior Advisor, Japan Self-Medication Industry
Dr. Tominaga is Associate Executive Director for International Programs. He supervises the overall strategy and conduct of international operations by PMDA. He joined MHLW after acquired PhD from Faculty of Pharmaceutical Sciences, the University of Tokyo. As a career official, he... Read More →


Tuesday February 5, 2019 15:30 - 16:00
Content Hub 1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

16:00

#DMD5: The Convergence of Medicines, Medical Devices and Analytics
Component Type: Session

Is the new European legislation on medical devices sufficient enough to handle the new paradigm of convergence between advanced medicinal products / diagnostics / apps / algorithms et al? Are we ready as regulators?

Chair

Thomas Senderovitz, DrMed, MD

Speaker

Setting the Scene
Thomas Senderovitz, DrMed, MD

Panel discussion
Elena Bonfiglioli

Panel discussion
Karl Broich, DrMed

Panel discussion
Lindsay Edwards

Panel discussion
Jorgen Scholler



Speakers
EB

Elena Bonfiglioli

Managing Director, Health and Life Sciences, Microsoft
avatar for Karl Broich

Karl Broich

President, Federal Institute for Drugs and Medical Devices (BfArM)
Physician, MD (certifications in Neurology, Psychiatry, Behavioural Psychotherapy). BfArM in Bonn (Germany): 2000 to 2014 several executive functions, since 08/2014 head (President). Work in several EMA committees; chair of CNS-Working Party. Current research: clinical trials methodology... Read More →
JS

Jorgen Scholler

Head of Division. Department of Health Technology, Techincal University Denmark
avatar for Thomas Senderovitz

Thomas Senderovitz

Chair of HMA Management Group; Director General, Danish Medicines Agency
Thomas Senderovitz took over as Director General of the Danish Medicines Agency on 1 April 2016. His career includes more than 20 years working with medicinal products and he has held several senior positions in international biopharmaceutical Companies. He previously worked at the... Read More →


Tuesday February 5, 2019 16:00 - 17:30
Hall D Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Regulatory Science
  • Tags Session

16:00

#EF01: Executive Forum (Invitation Only): Europe’s Readiness to Face the Requirements of Future Therapies
Component Type: Session

Effective therapies are coming fast and furious, often with higher and higher pricing. While effective treatments increase efficiency and reduce treatment costs, there are no processes nor mechanisms that exist in Europe to claw back funding from regional budgets that create savings locally. What needs to change, if anything? What evidence and systems need to be developed to fix this problem, or is it not a problem at all? This session will discuss: • The market for Orphan indications is growing 11% per year, and will be 25% of drug spending by the year 2025. Is this a good or a bad thing? • Playing Hot Potato with Pricing - How do we build a reimbursement system fit for purpose?

Chair

Duane Schulthess, MBA

Speaker

Panelist
Alexander Natz, JD

Panelist
Bettina Ryll

Panel Discussion
Tomas Salmonson, PhD

Panelist
Anja Schiel, PhD



Speakers
AN

Alexander Natz

Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
Dr. Natz is Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (www.eucope.org). From 2008-2013 he has been heading the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. (BPI). Before, he has been a lawyer with Sträter Law Firm in Germany... Read More →
avatar for Bettina Ryll

Bettina Ryll

Chair ESMO Patient Advocates Working Group (PAWG), Melanoma Patients
Bettina Ryll, MD/PhD founded the Melanoma Patient Network Europe in 2013 and developed a special interest in patient-centric clinical research and drug development. Bettina’s current areas of focus are Adaptive Licensing/ MAPPS , innovative sustainable healthcare models and patient-centered... Read More →
avatar for Anja Schiel

Anja Schiel

Senior Adviser/Statistician, Unit for HTA and Reimbursement, Norwegian Medicines Agency (NoMA)
Anja Schiel is working as Senior Advisor and Statistician for Norwegian Medicines Agency (NoMA. She has studied Biology at the Johannes Gutenberg-University Mainz, holds a PhD from the Free University Amsterdam and has many years of experience in medical research. Since 2017, she... Read More →
avatar for Duane Schulthess

Duane Schulthess

Managing Director, Vital Transformation
Duane is the Managing Director of Vital Transformation which consults to national health authorities, blue chip multi-national organisations, governments, and stakeholder groups on healthcare policy and technology. He and his firm have developed many unique techniques and methods... Read More →
avatar for Tomas Salmonson

Tomas Salmonson

Senior Scientific Advisor, Medical Products Agency (MPA)
Tomas Salmonson, M.Sc., PhD, brings outstanding experience and expertise from a long career in the regulation of medicines both on a national and European level to his new role. A pharmacist by training, he is currently senior scientific advisor at the Swedish Medical Products Agency... Read More →


Tuesday February 5, 2019 16:00 - 17:30
0.94-0.95 (Level 0) Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

16:00

#LOT01: Pharmacovigilance and Post Market Surveillance
Component Type: Session

Many things have changed since the 1960s and the events that institutionalised (pharmaco)vigilance as we know it today. While the focus on public safety might not have changed, ways of achieving this goal as well as processes and the people behind them, as well as their professional perception have come a long way. In this session we will present what is pharmacovigilance and post market surveillance today, touching upon drugs and medical devices and sharing perspectives from professional with different levels of experience. Speakers will not only present to you different parts of vigilance, but will also present you their career progressions which brought them in the roles they are today. In the end the panel will be open for your questions and will look where pharmacovigilance is headed in the future.

Chair

Milos Stojkovic, MPharm

Speaker

Speaker
Michelle Elizabeth Grimes, MSc

Speaker
Arton Baftiu, PharmD



Speakers
avatar for Arton Baftiu

Arton Baftiu

Scientific Officer, Norwegian Medicines Agency
Arton Baftiu, PhD, is a pharmacist who has focused his research work on pharmacoepidemiology and clinical pharmacology through national and international collaborations. Arton is experienced in using prescription databases to study patterns and changes of use of antiepileptic drugs... Read More →
avatar for Michelle Grimes

Michelle Grimes

Executive Director Global Clinical Safety & PV, Merck Sharp & Dohme Ltd
Michelle is leading Pharmacovigilance Operations for the EMEA region at MSD. She has 20 years of experience in the Pharma industry and worked in Clinical Research and consulting prior to moving into Pharmacovigilance. Since joining MSD in 2002 she has performed various roles within... Read More →
avatar for Milos Stojkovic

Milos Stojkovic

Sr. Safety Specialist, Smith & Nephew
Clinical safety professional, engaged with safety oversight of medical devices clinical trials globally in line with good clinical practice guidelines and applicable national regulations. Pharmacist by training with experience in regulatory compliance and quality principles related... Read More →


Tuesday February 5, 2019 16:00 - 17:30
0.96-0.97 (Level 0) Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

16:00

#WL01: Women in Leadership Forum
Component Type: Session

Come hear burning issues and shared experiences from women in leadership positions, including lessons learned and gender gaps in senior positions.

Chair

Tiia Metiäinen, MPharm

Speaker

Panelist
Vicki Edwards, RPh

Panelist
Barbara Lopez Kunz, MSc

Panelist
Rebecca A. Vermeulen, RPh

Panelist
Maria Raad

Panelist
Niklas Hedberg, MPharm

Panelist
Nicola Bedlington

Panelist
Peter Schueler, DrMed, MD



Speakers
avatar for Rebecca Vermeulen

Rebecca Vermeulen

Head, Customer Strategy Global Medical Affairs, Hoffmann-La Roche Ltd.
Rebecca Vermeulen, RPh, brings a variety of experiences to her role as Customer Strategy and Patient Partnership for Global Medical Affairs at Roche. She has served in numerous functions including Medical Affairs, Clinical Research, Sales, Medical Communications, Medical Science Liaisons... Read More →
avatar for Vicki Edwards

Vicki Edwards

Vice President, Pharmacovigilance Excellence and QPPV, AbbVie, Inc.
Qualified as a pharmacist in 1981 and started her career in hospital pharmacy. In 1983 she specialised in Drug Information Services and moved to Kuwait to set up and run the first National Drug Information Centre. On her return to the UK, Vicki spent the next four years in community... Read More →
avatar for Barbara Lopez Kunz

Barbara Lopez Kunz

Global Chief Executive, DIA
Barbara Lopez Kunz, MS, is responsible for the leadership and oversight of DIA global operations, implementing strategies that focus on driving thought leadership and innovation in therapeutic development to improve the health of people worldwide. Ms. Lopez Kunz previously served... Read More →
avatar for Tiia Metiäinen

Tiia Metiäinen

Specialist, Regulatory Science & Advocacy, Lundbeck
Tiia Metiäinen is currently working as Specialist, Regulatory Science and Advocacy at Lundbeck headquarters in Copenhagen, focusing on regulatory policy and intelligence from a global development angle. H. Lundbeck A/S is a global pharmaceutical company specialized in psychiatric... Read More →
avatar for Nicola Bedlington

Nicola Bedlington

Secretary General, European Patient's Forum
Nicola Bedlington was first Executive Director of the European Patients’ Forum (EUPATI), which she continues to serve as its Secretary General, and is co-founder of Patients Access Partnership (PACT). She previously provided leadership to the Swiss government’s Environment and... Read More →
avatar for Niklas Hedberg

Niklas Hedberg

Chair EUnetHTA Executive Board, Chief Pharmacist, Dental and Pharmaceutical Benefits Agency, TLV
Niklas Hedberg, MSc, is Chief Pharmacist for the Dental and Pharmaceuticals Benefits Agency (TLV) in Sweden. He is also Chair of the EUnetHTA Executive Board, TLV’s lead partner in EUnetHTA, and has led EUnetHTA WP3 – Evaluation since 2016. Mr. Hedberg has broad experience in... Read More →
avatar for Maria Raad

Maria Raad

Actelion


Tuesday February 5, 2019 16:00 - 17:30
DIAlogue Space Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

17:30

#NW01: Welcome Reception in the Exhibition Hall
Component Type: Social Event




Tuesday February 5, 2019 17:30 - 19:00
Exhibition Hall Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
 
Wednesday, February 6
 

08:30

#KN2: Will Virtual Patients Allow for Virtual Trials?
Component Type: Session



Speaker

Will Virtual Patients Allow for Virtual Trials?
Hans Lehrach



Speakers
avatar for Hans Lehrach

Hans Lehrach

Director, Max Planck Institute for Molecular Genetics
Among Hans Lehrach's numerous scientific achievements are the early contribution to the cloning of collagen cDNA, early positional cloning work (Chorea Huntington gene etc.), key work on technologies such as protein microarrays, protein interactome analysis, yeast artificial chromosomes... Read More →


Wednesday February 6, 2019 08:30 - 09:00
E1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Clinical Development
  • Tags Session

09:15

#DMD7: Digital Trials, Sensors, Bots, AI/Machine Learning, RWD– Will Product Approvals Be Accelerated By These New Technologies?
Component Type: Session

Digital trials or “smart” trials, AI, Bots are the new buzzwords in our industry. But what do we mean by digital trials and how will these new technologies accelerate product approvals? Drug development timelines and cost keep increasing while reimbursement is diminishing; a paradigm shift is needed in the way we develop drugs. Will this come from new technologies and digitisation? And how will these technologies impact drug development process? What are the implications for regulators and how will they approve usage of sensors, bots and ML algorithm. Do pharma and regulators need to adapt their process and organisations (e.g., introduce a Chief Digital Officer role). And finally, will the patients accept these new technologies with increasing patient adherence and preparing a natural continuum with mHealth?

Chair

Isabelle M de Zegher, DrMed, MD, MS, MSc

Speaker

Panel Discussion
Ulo Palm, MD, PhD, MBA

Panel Discussion
Thomas Senderovitz, DrMed, MD

Panel Discussion
Peter Shone

Panel Discussion
Meni Styliadou



Speakers
UP

Ulo Palm

Senior Vice President, Head Global Drug Development Operations, Allergan
avatar for Thomas Senderovitz

Thomas Senderovitz

Chair of HMA Management Group; Director General, Danish Medicines Agency
Thomas Senderovitz took over as Director General of the Danish Medicines Agency on 1 April 2016. His career includes more than 20 years working with medicinal products and he has held several senior positions in international biopharmaceutical Companies. He previously worked at the... Read More →
PS

Peter Shone

Corporate Vice President, R&D Engineering, PAREXEL Informatics
MS

Meni Styliadou

VP Government Affairs & Public Policy, Europe & Canada, Takeda
avatar for Isabelle de Zegher

Isabelle de Zegher

Vice President, PAREXEL Informatics
Isabelle de Zegher is Vice President, Integrated Solutions at PAREXEL Informatics where she is responsible for engineering strategy around Big Data, BI and Advanced Analytics. She has 25 years’ experience in Life Sciences, including extensive work on cross-industry forum on integration... Read More →


Wednesday February 6, 2019 09:15 - 10:15
E1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Data and Data Standards
  • Tags Session

09:15

#DMD8: EU Cooperation on HTA and beyond - Current Action and Future Developments
Component Type: Session

With the confirmed participation of the European Commission, NICE, a Ministry of Health advisor and the coordination of EUCOPE, this panel discussion will provide a deep overview of EU Cooperation on HTA, namely on the centralisation of HTA assessment and the different stakeholders involved.

Chair

Alexander Natz, JD

Speaker

Panelist
Ana-Eva Ampelas, LLM

Panelist
Zoe Garrett

Panelist
Diane Kleinermans



Speakers
AA

Ana-Eva Ampelas

Head of Unit, Medical products: Quality, Safety, Innovation, European Commission
Anna-Eva Ampelas is Head of Unit for Medical Products: quality, safety, innovation in Unit B4 in DG SANTE, European Commission. In this capacity, she manages files on medicinal products (falsified medicines, clinical trials, shortages, GMP etc); Health Technology Assessments (HTA... Read More →
AN

Alexander Natz

Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
Dr. Natz is Secretary General of the European Confederation of Pharmaceutical Entrepreneurs (www.eucope.org). From 2008-2013 he has been heading the Brussels Office of Bundesverband der Pharmazeutischen Industrie e.V. (BPI). Before, he has been a lawyer with Sträter Law Firm in Germany... Read More →
ZG

Zoe Garrett

SeniorTechnical Adviser – EUnetHTA, National Institute for Health and Care Excellence (NICE)
DK

Diane Kleinermans

Advisor, Ministry of Health and Social Affairs


Wednesday February 6, 2019 09:15 - 10:15
E2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Value and Access
  • Tags Session

09:15

#DMD9: Brexit and the European Network: 1,5 months to go! Where Do We Stand?
Component Type: Session

The session will discuss the challenges and solutions identified within the EU Regulatory Network on how to carry forward after the UK is no longer an official member of the European Union. It will discuss the tactical solutions put in place to continue operating without disturbance and also give advice to the industry on the expectations on them.

Chair

Christa Wirthumer-Hoche, PhD

Speaker

Panel Discussion
Kora H Doorduyn-van der Stoep, MSc, RPh

Panel Discussion
Anthony Humphreys, MPharm

Panel Discussion
Hugo Hurts

Panel Discussion
Nick Meade, MSc

Panel Discussion
Lorraine Nolan, PhD

Panel Discussion
Aimad Torqui, MSc



Speakers
avatar for Hugo Hurts

Hugo Hurts

Chair HMA Task Force; Executive Director, Medicines Evaluation Board (MEB)
NM

Nick Meade

Director of Policy, Genetic Alliance UK
Nick Meade leads the policy work of Genetic Alliance UK. The organisation works on behalf of more than 230 patient organisation member groups, aiming to improve outcomes for everyone affected by genetic, rare and undiagnosed conditions through evidence-based influencing and campaigning... Read More →
avatar for Christa Wirthumer-Hoche

Christa Wirthumer-Hoche

Chair, EMA Management Board, Head, Austrian Medicines and Medical Devices Agency
Christa Wirthumer-Hoche studied biochemistry TU Vienna, doctoral thesis at Medical Physiology. Starting at the AT Nat. Inst. for Quality Control of Drugs - quality assessment, Head of Regulatory Affairs in the Ministry of Health, Now Head of the Austrian Medicines and Medical Devices... Read More →
avatar for Anthony Humphreys

Anthony Humphreys

Head of Scientific Committees Regulatory Science Strategy, European Medicines Agency, European Union
He is the Head of Scientific Committees Regulatory Science Strategy Division (SciRS). He is responsible for providing leadership in the Agency in the areas of Scientific Committees Coordination and Regulatory Science Strategy in support of delivering the EMRN 2020 Strategy. He chairs... Read More →
avatar for Lorraine Nolan

Lorraine Nolan

Chief Executive, Health Products Regulatory Authority (HPRA)
Ms Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming... Read More →
KD

Kora Doorduyn-van der Stoep

CMDh member (EU-representative)/Policy adviser, Medicines Evaluation Board
Her current position (since 2009) is CMDh member (EU-representative)/Policy adviser of the department Policy, Governance and Regulatory Affairs. Since May 2009 she is acting as Member and official representative in the CMDh on behalf of the MEB. She is member of several working parties... Read More →
AT

Aimad Torqui

Director Global Regulatory Policy, MSD
Aimad Torqui is Director of Global Regulatory Policy at MSD. Previous employment includes Medicines Evaluation Board and Novartis Vaccines. He has worked with governments, regulators, trade bodies and other external stakeholders to shape robust science-based regulatory policy.


Wednesday February 6, 2019 09:15 - 10:15
F1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Regulatory Science
  • Tags Session

10:15

#CHS01: New Legislative Requirements in PV: How to Be More Efficient and Minimise Resources
Component Type: Session



Chair

Carmen Arques


Speakers
CA

Carmen Arques

Pharmacovigilance Manager, AZIERTA


Wednesday February 6, 2019 10:15 - 10:45
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

10:15

#CB2: Coffee Break in the Exhibition Hall
Component Type: Social Event




Wednesday February 6, 2019 10:15 - 10:45
Exhibition Hall Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

10:15

#PS04: Oral Poster Session 4 - Regulatory Science & Value and Access Content Hub
Component Type: Session



Speaker

An overview of the current status and trends in the Breakthrough Designation, PRIME and SAKIGAKE expedited review programs
Pedro Borga, MPharm

Early Actions granted by FDA: a review of the frequency and importance of NDA/BLA approvals in advance of DUFA action date
Camille Metais, MSc



Speakers
CM

Camille Metais

Senior Director Regulatory Affairs, Alexion Pharma GmbH
avatar for Pedro Borga

Pedro Borga

Consultant, Lifescience Dynamics Ltd


Wednesday February 6, 2019 10:15 - 10:45
Content Hub 4 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

10:45

#CH101: Finding The Right Formula – The Ups and Downs of a Consumer Group’s Work With Industry 2010-2018
Component Type: Session
Level: Basic




Speakers
avatar for Richard Stephens

Richard Stephens

Chair of the Consumer Liaison Group, UK National Cancer Research Institute
Richard has had two cancers, a heart emergency, and has multi morbidities. He has participated in four clinical trials and eight other studies. Richard Chairs NCRI’s Consumer Forum and serves on strategic groups for NIHR, NHS England, Cancer Research UK, Genomics England and others... Read More →


Wednesday February 6, 2019 10:45 - 11:15
Content Hub 1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

10:45

#CH301: Development of an Algorithm to Detect Antibiotic-induced Acute Kidney Injury Using Electronic Medical Records
Component Type: Session
Level: Intermediate



Chair

Sreemanee Raaj Dorajoo, PhD


Speakers
avatar for Sreemanee Dorajoo

Sreemanee Dorajoo

Data Analyst, Health Sciences Authority, Singapore
Dr Dorajoo is a Data Analyst at the Health Sciences Authority (HSA), the drug regulatory agency in Singapore. A pharmacist by training, part of his time is devoted to serving the Adverse Event Monitoring Team at HSA, reviewing adverse event reports to detect emerging drug safety signals... Read More →


Wednesday February 6, 2019 10:45 - 11:15
Content Hub 3 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

10:45

#S0101: Optimising Orphan Drug Development in the EU
Component Type: Session

Following an unprecedented decade of change for rare diseases and orphan drugs, it's time to think about the future and make sure the most meaningful times of change are about to start. The session will focus on the much needed stakeholder engagement and explore the regulatory and scientific trends in the field and is the first part of a series on orphan and paediatric drug development in the EU.

Chair

Bruno Sepodes, PharmD, PhD, MSc

Speaker

Panel Discussion
Violeta Stoyanova, MD, PhD, MPH

Panel Discussion
Martine Zimmermann, PharmD

Panel Discussion
Sandra L. Kweder, MD

Panel Discussion
François Houyez



Speakers
avatar for François Houyez

François Houyez

Treatment Information and Access Director, Health Policy Advisor, European Organisation for Rare Diseases (EURODIS)
François Houÿez is working at the European Organisation for Rare Diseases EURORDIS where he is Director of Treatment Information and Access, Policy Advisor. He has always been working as a patient advocate since the early 90s, first in the HIV/AIDS advocacy, and in rare diseases... Read More →
avatar for Sandra Kweder

Sandra Kweder

Deputy Director, Liaison to the EMA, Office of International Programs, OC, FDA
Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA Office of International Programs. Dr. Kweder previously served for more than a decade as Deputy Director, Office of New Drugs, in FDA’s Center for Drug Evaluation & Research, where she actively led numerous... Read More →
avatar for Bruno Sepodes

Bruno Sepodes

Vice Chair CHMP; Member COMP; Professor of Pharmacology and Pharmacotherapy, University of Lisbon
Bruno Sepodes is a Professor of Pharmacology and Pharmacotherapy at the Faculty of Pharmacy of the University of Lisbon (Portugal). Besides being Senior non-clinical expert for INFARMED (Portuguese National Authority for Medicines and Health Products), he became a member of the European... Read More →
avatar for Violeta Stoyanova

Violeta Stoyanova

Chair COMP EMA, Chair Scientific and Regulatory Advice MEB, Medicines Evaluation Board
Dr. Stoyanova-Beninska is Chair of the Committee for Orphan Medicinal Products at the European Medicines Agency since September 2018. In the previous 6 years she has been the member from the Netherlands at the COMP. She is also additional expert in the CNS working party and was previously... Read More →
avatar for Martine Zimmermann

Martine Zimmermann

Senior Vice President, Head of Global Regulatory Affairs, Alexion Pharma International Sàrl
Martine is global head of regulatory affairs at Alexion Pharmaceuticals. She is based in Zurich, Switzerland. She has over 20 years of combined R&D and global regulatory strategy experience. She joined Alexion in 2009 and since then has been dedicated to the registration of Orphan... Read More →


Wednesday February 6, 2019 10:45 - 11:45
E1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Regulatory Science
  • Tags Session

10:45

#S0201: The Digital Transformation in Regulatory Affairs – What is Hype and What is Real?
Component Type: Session

This session will explore the following questions: What digital technologies can Regulatory Affairs departments investigate to streamline processes, link data together, and unlock information? Will artificial intelligence, robotic process automation, natural language processing and/or blockchain enable these improvements for regulatory professionals?

Chair

Scott Cleve

Speaker

Transforming Regulatory Affairs - Will Robots and Artificial Intelligence do the Job?
Niels Buch Leander, PhD

Exploring Digital Technology in Regulatory Affairs
Scott Cleve



Speakers
avatar for Scott Cleve

Scott Cleve

Head of Global Regulatory Operations, Boehringer Ingelheim
Scott Cleve is currently the Head of Global Regulatory Operations at Boehringer Ingelheim responsible for submission publishing, regulatory information management, and system business support. His past experience includes roles within Regulatory Operations at AbbVie and Astellas... Read More →
avatar for Niels Leander

Niels Leander

Consulting Director, NNIT
Dr. Niels Buch Leander is a Consulting Director and lead for Regulatory Affairs at NNIT, a global IT service provider to the pharmaceutical industry. Dr. Leander has 10 years of R&D IT project experience with eCTD, eTMF, EDMS, RIMS, xEVMPD and ISO IDMP and hence extensive experience... Read More →


Wednesday February 6, 2019 10:45 - 11:45
G1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Translational Medicine
  • Tags Session

10:45

#S0301: Impact of Pharmacovigilance on Public Health
Component Type: Session



Chair

Sabine Straus, MD, PhD, MSc

Speaker

Panel Discussion
Maia Uuskula

Panel Discussion
Vicki Edwards, RPh

Panel Discussion
Inge Zomerdijk, MSc

Panel Discussion
Marco Greco

Panel Discussion
Valerie Strassmann, PhD, RPh



Speakers
avatar for Vicki Edwards

Vicki Edwards

Vice President, Pharmacovigilance Excellence and QPPV, AbbVie, Inc.
Qualified as a pharmacist in 1981 and started her career in hospital pharmacy. In 1983 she specialised in Drug Information Services and moved to Kuwait to set up and run the first National Drug Information Centre. On her return to the UK, Vicki spent the next four years in community... Read More →
avatar for Marco Greco

Marco Greco

President, European Federation of Crohn's and Ulcerative Colitis Associations
Marco Greco is president of the European Patients’ Forum since 2014. He has been Chairman of the European Federation of Crohn’s and Ulcerative Colitis Associations (EFCCA) from 2008 to 2014. He has also been the founder of the EFCCA Youth Group, and its leader from 2003 till 2007... Read More →
VS

Valerie Strassmann

Pharmacovigilance Assessor, Federal Institute For Drugs and Medical Devices
Valerie Strassmann is a pharmacist holding a PhD in Pharmacology. From 2010 to 2013 she worked at the Federal Institute for Drugs and Medical Devices (BfArM) in Germany as Pharmacovigilance Assessor. Since 2013 she is Head of the Department 'Post-Authorisation Safety Studies, Pharmacovigilance... Read More →
avatar for Sabine Straus

Sabine Straus

PRAC Chair, Staff Member, Medicines Evaluation Board (MEB)
Dr. Sabine Straus has been with the Medicines Evaluation Board (MEB) in the Netherlands since 1997, where she started as an Assessor Pharmacovigilance. Prior to working at the MEB she held different positions in the pharmaceutical industry, her last job as Medical Director at Searle... Read More →
avatar for Maia Uuskula

Maia Uuskula

Head of the Bureau of Pharmacovigilance, State Agency of Medicines
avatar for Inge Zomerdijk

Inge Zomerdijk

Pharmacovigilance Assessor, Medicines Evaluation Board (MEB)
Inge Zomerdijk is currently working at the pharmacovigilance department of the Medicines Evaluation Board in the Netherlands. As a regulator she has experiences in assessing Risk Management Plans, national implementation of risk minimization measures as well as benefit-risk assessments... Read More →


Wednesday February 6, 2019 10:45 - 11:45
E2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Pharmacovigilance
  • Tags Session

10:45

#S0401: Re-Thinking Clinical Development
Component Type: Session

How can the best of big data and the randomised clinical trial be integrated to support regulatory decision making? In this DIALogue session four panelist will make their case in a 5-minute TED-style talk on how their solutions using e.g. Augmented Intelligence and wearables will improve trial efficiency and the chance of regulatory approval. The audience will be asked to express their enthusiasm or skepticism and suggest barriers and facilitators for the solutions proposed to support drug development. These barriers and facilitators will fuel further discussion between panelists and the audience.

Chair

Peter Mol, PhD, RPh

Speaker

Big Data: Moving from Artificial Trials to a Smarter Regulatory Process
Bruno Boulanger, PhD

Advanced Analytics on Longitudinal Health Records
Frederik Floether, PhD, MA, MSc

Using Historical Data to Transform Clinical Trials
Alun Bedding, PhD



Speakers
avatar for Peter Mol

Peter Mol

Member SAWP, Principal Clinical Assessor, Dutch Medicines Evaluation Board & University Medical Center Groningen
Peter Mol is a principal assessor at the Dutch Medicines Evaluation Board and a member (vice chair) of EMA’s Scientific Advice Working Party. He is chair of the EMA Cross-Committee Task force on Registries. He is also an assistant professor at the University Medical Center Groningen... Read More →
avatar for Alun Bedding

Alun Bedding

Director (Group Manager) Biostatistics, pRED I3, Roche Products Ltd
Alun Bedding has worked in the Pharmaceutical Industry for nearly 30 years and has experience in all areas of drug development, from pre-clinical to post registration. Alun currently works as a Director of Biostatistics in Roche, leading a team of statisticians working in early clinical... Read More →
avatar for Bruno Boulanger

Bruno Boulanger

Chief Scientific Officer, PharmaLex
Bruno has 25 years of experience in several areas of pharmaceutical research and industry including discovery, toxicology, CMC and early clinical phases. He holds various positions in Europe and in USA. Bruno joined UCB Pharma in 2007 as Director of Exploratory Statistics. Bruno is... Read More →
avatar for Frederik Floether

Frederik Floether

IBM Q Consulting Global Life Sciences Leader, Quantum & AI, IBM
avatar for Jonathan Moshinsky

Jonathan Moshinsky

Head of Market Strategy, Umotif
Jonathan is responsible for Strategy and Marketing at uMotif. He has 10 years' experience in software strategy and management consulting for Life Sciences. Prior to uMotif, Jonathan was part of Veeva's Commercial strategy team, held senior consulting roles at IBM and was a Senior... Read More →


Wednesday February 6, 2019 10:45 - 11:45
DIAlogue Space Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Clinical Development
  • Tags Session

10:45

#S0501: The Added Value of Medical Functions: Building a Long-Term Strategy
Component Type: Session



Chair

Danie Du Plessis, MD, MBA

Speaker

Frontend of Medical Function: What Medical Functions Need to be More Strategic?
Danie Du Plessis, MD, MBA

Can Patient Engagement Drive Change in Medical Affairs?
Rebecca A. Vermeulen, RPh



Speakers
avatar for Rebecca Vermeulen

Rebecca Vermeulen

Head, Customer Strategy Global Medical Affairs, Hoffmann-La Roche Ltd.
Rebecca Vermeulen, RPh, brings a variety of experiences to her role as Customer Strategy and Patient Partnership for Global Medical Affairs at Roche. She has served in numerous functions including Medical Affairs, Clinical Research, Sales, Medical Communications, Medical Science Liaisons... Read More →
avatar for Danie Du Plessis

Danie Du Plessis

Managing Director and Owner, The Next Version
After completing his medical studies and a Master’s Degree in Pharmacology in South Africa, Danie spent 3 years working in a primary care setting including his own private practice. He joined the pharmaceutical industry in 1991 and held roles of increasing responsibility and leadership... Read More →


Wednesday February 6, 2019 10:45 - 11:45
G2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Medical Affairs
  • Tags Session

10:45

#S0601: From Faster Regulatory Approval to Actual Patient Access: What Could be Done to Increase Certainty around Clinical Benefit and Predictability of Decision Making?
Component Type: Session

Compelling value demonstration is critical in securing patient access to new treatment options today and in the future and even more so for products potentially undergoing accelerated pathways. On the basis of case studies, panellists will present new approaches that could be explored and will highlight what they see as opportunities and important learning.

Chair

Claudine Sapède, PharmD

Speaker

Bridging Clinical Trials to the Real World at Times of Launch – A Case Study in Alzheimer’s Disease
Michael Happich, PhD

A Case Study in Addressing Comparative Effectiveness Evidence Gaps in Personalised Medicine
Jessica Davies, MPH



Speakers
avatar for Jessica Davies

Jessica Davies

Senior Data Scientist, RWD Collaborations, F. Hoffmann-La Roche Ltd
avatar for Michael Happich

Michael Happich

HTA director, Eli Lilly
Michael Happich is International Health Technology Assessment (HTA) director at Eli Lilly based in Bad Homburg, Germany. He leads a team of HTA & RWE scientists to support international drug launches, HTA submissions and observational research in the autoimmune, pain and neurology... Read More →
avatar for Claudine Sapède

Claudine Sapède

Global HTA and Payment Policy Lead, F. Hoffmann-La Roche
Claudine Sapède is Global HTA and Payment Policy Lead at Roche based in Basel. She works on the development of Roche’s external policy positions and projects on market access related subjects including HTA and pricing. She has been working in the field of reimbursement, market... Read More →


Wednesday February 6, 2019 10:45 - 11:45
K1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Value and Access
  • Tags Session

10:45

#S0701: Digital Disruptors: What Do We Mean?
Component Type: Session

There is a huge opportunity for significant change in Clinical research, by embracing Digital Approaches such as mHealth, wearables, Patient Apps, remote monitoring, siteless trials, digital therapies, EHR integration. What will this disruption mean and how can we harness the potential of digital for better healthcare?

Chair

Jonathan Palmer

Speaker

Panel Discussion
Isabelle M de Zegher, DrMed, MD, MS, MSc

Panel Discussion
Chris Walker, MSc

Panel Discussion
Jeremy Wyatt, MBA



Speakers
avatar for Isabelle de Zegher

Isabelle de Zegher

Vice President, PAREXEL Informatics
Isabelle de Zegher is Vice President, Integrated Solutions at PAREXEL Informatics where she is responsible for engineering strategy around Big Data, BI and Advanced Analytics. She has 25 years’ experience in Life Sciences, including extensive work on cross-industry forum on integration... Read More →
avatar for Chris Walker

Chris Walker

Vice President, European Head of Regulatory Affairs, Amgen Ltd
Chris Walker (MSc RA & BSc Hons), is Head of Regulatory Affairs for Europe for Amgen and Head of the UK R&D sites.. Chris is chair of the Digital Health Taskforce at EFPIA, a member of the Innovation BSC & Regulatory Strategy Groups. Chris leads the regulatory strategy team for Amgen’s... Read More →
avatar for Jonathan Palmer

Jonathan Palmer

Senior Director, Product Strategy, Digital Trials, Oracle Health Sciences
Jonathan leads Product Strategy for Digital Trials within Oracle’s Health Sciences Global Business Unit. He is responsible for defining, and delivering, new innovative Digital/mHealth solutions. He has spent over 20 years within Oracle’s Clinical Trial business teams delivering... Read More →
avatar for Jeremy Wyatt

Jeremy Wyatt

Chief Technology Officer; SVP Product Development, ActiGraph
Jeremy Wyatt is the CTO at ActiGraph, a leading global provider of physical activity and sleep monitoring solutions for the pharmaceutical and academic industries. ActiGraph's ecosystem of of medical-grade physical activity monitors and cloud software ensure clients are collecting... Read More →


Wednesday February 6, 2019 10:45 - 11:45
F2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Data and Data Standards
  • Tags Session

10:45

#S0801: The Impact of Innovation and Novel Pathways: The Role of the Regulator
Component Type: Session

The International Coalition of Medicines Regulatory Authorities (ICMRA) will explore role of regulators in the current international landscape, including the impact of innovation and novel pathways. The session will be delivered by members of ICMRA who represent a number of leading regulators across Europe and beyond.

Chair

Ian Hudson

Speaker

Horizon Scanning: Methodologies and Best Practice
Tatsuya Kondo, MD, PhD

Leveraging Outcomes of Horizon Scanning
Agnès Saint-Raymond, MD

Novel Approaches to Licensing
John Patrick Stewart, MD

Overview of Projects
Lorraine Nolan, PhD



Speakers
avatar for Ian Hudson

Ian Hudson

Chief Executive, Medicines and Healthcare products Regulatory Agency (MHRA)
Dr Ian Hudson became Chief Executive of the MHRA in September 2013. He is a physician who practiced as a paediatrician prior to working in the pharmaceutical industry in clinical research and development. In 2001 he joined the former Medicines Control Agency as its Licencing Division... Read More →
avatar for Tatsuya Kondo

Tatsuya Kondo

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tatsuya Kondo is Chief Executive of PMDA since 2008. He spent most of his career as a neurosurgeon after his graduation from the University of Tokyo in 1968. He has various experiences including a hospital doctor, a fellowship in Max-Planck Institute for brain tumor research... Read More →
avatar for Lorraine Nolan

Lorraine Nolan

Chief Executive, Health Products Regulatory Authority (HPRA)
Ms Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming... Read More →
avatar for Agnès Saint-Raymond

Agnès Saint-Raymond

Head of International Affairs, Head of Portfolio Board, European Medicines Agency (EMA)
Head of International Affairs, Head of Portfolio Board MD and qualified Paediatrician. Joined EMA in 2000. Head of Special Areas for Human Medicines (Paediatric Medicines, Orphan Medicines, Scientific Advice, SME Office, and Scientific Support & Projects) until 2013. Head of Portfolio... Read More →
avatar for John Stewart

John Stewart

Director General, Health Canada
The Director General of the Therapeutic Products Directorate in the Health Products and Food Branch of Health Canada; overseeing the review and approval of drug and medical devices submissions seeking authorization to be sold on the Canadian market or in the context of clinical trials... Read More →


Wednesday February 6, 2019 10:45 - 11:45
K2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Regulatory Science
  • Tags Session

10:45

#S0901: Clinical Trials and GDPR
Component Type: Session

In recent guidance, both the European Commission and the Article 29 Committee overseeing the GDPR have suggested that consent should not be the preferred basis for processing data in clinical trials. This panel will explore why this view was reached and what its implications are for the conduct of research and relations with research participants. We will in particular look at how the ethical and legal safeguards that govern clinical research, viewed from the perspective of the privacy regulator, and how these relate to the principle of accountability under GDPR.

Chair

Brendan Barnes

Speaker

The View of the Privacy Regulator
Joao Soares da Silva, MA

Company Experience in Adapting to the New Requirements
Lee Parker, JD, LLM

What do Trial Participants and Patients Think?
Souzi Makri



Speakers
BB

Brendan Barnes

Director, Multilateral Issues and Health Policy, EFPIA
BB

Brendan Barnes

Director, Multilateral Issues and Health Policy, EFPIA
avatar for Souzi Makri

Souzi Makri

Vice-President, Cyprus League Against Rheumatism
avatar for Lee Parker

Lee Parker

Director EU+ Privacy, Biogen International Gmbh
Lee Parker is Director Data Privacy Europe and Canada at Biogen. He also acts as EU Data Protection Officer. Lee is an experienced data privacy professional and English-qualified solicitor, with numerous years of pharmaceutical industry data protection experience. He is a member of... Read More →
JS

Joao Soares da Silva

Legal officer / DPO, European Data Protection Board
João Soares da Silva is currently a legal and data protection officer at the European Data Protection Board (EDPB). Before, he worked as a Data Protection Coordinator for the European Commission (DG SANTE), as a DPO at the European Research Council Executive Agency (ERCEA) and as... Read More →


Wednesday February 6, 2019 10:45 - 11:45
F1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Clinical Development
  • Tags Session

11:15

#CH102: The Language of Patients Meets the Language of Safety Science
Component Type: Session
Level: Intermediate

The key differentiator to AbbVie’s approach is the incorporation of safety science, behavioral science and health literacy to amplify the patient’s voice in the creation of products/programs to support informed decision making and promote safe use. Key Presenters: LINDA SCARAZZINI, MD, Vice President, PV CHERYL L RENZ, MD, Head, Benefit-Risk Management JAMES DUHIG, PHD, Director, Patient Integration AbbVie’s Patient Safety Teams – Benefit-Risk Management and Patient Integration – will present a unified session on patient centricity and then lead a participant discussion focused on the potential to bring innovative activities into patient safety organizations. In doing so, we will be able to show how AbbVie is demonstrating scientific leadership in patient focused drug development through research in patient and health professional decision-making, wearables, health literacy, and human-centered design to achieve a remarkable impact on the treatment, amelioration and elimination of disease. The presentation and ensuing discussion will showcase examples of incorporating the patient perspective into the design and implementation of innovative healthcare educational materials, applicable across global markets, to communicate essential risk information as a means to minimize key risks and ultimately optimize a product’s benefit-risk profile. The presentation will also demonstrate how a patient preference study uses hypothetical treatments with varied benefit-risk profiles to determine the relative importance of different benefit and risk attributes to patients and how this information can inform a company’s benefit-risk decision-making. In parallel, the discussion will ask participants to assess key successes achieved in combining behavioral science and benefit-risk management expertise and opportunities to similarly amplify the patient voice in their own organizations.


Speakers
avatar for James Duhig

James Duhig

Director, Patient Integration, AbbVie, Inc.
Health Literacy | Human Factors / Usability in patient safety | | Dr. James (Jay) Duhig, Ph.D., is director of Patient Integration at AbbVie. He has expertise in human factors, health literacy, risk communication and the development of drug and device instructional... Read More →


Wednesday February 6, 2019 11:15 - 11:45
Content Hub 1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

11:15

#CH302: AI on the Rise - digitally transforming pharma’s regulatory processes
Component Type: Session
Level: Intermediate

Digital solutions are already being rolled out in pharma R&D and pharmacovigilance, but the regulatory process remains largely manual and time consuming, with slow adoption of innovative digital approaches. However, new solutions are being developed to facilitate digital transformation in the regulatory environment. The combination of smarter working processes and proper use of innovative technologies will drive efficiencies in regulatory submissions while keeping high standards of quality and compliance. Ultimately this could translate into time and resource savings for marketing authorisations and post-marketing requirements that will revolutionise the regulatory environment. Evidently, there are already tools that provide basic automation support (compilation, publishing and storage/archival of documents). In this session we would like to focus on further gains these tech solutions can bring. We will pick up on some of the technologies such as Robot Process Automation (RPA), Artificial Intelligence (AI) or machine learning that are already to some extent present in the regulatory environment and later expand this discussion into more future approaches as e.g. support for intelligent drafting of key documents, automatic and intelligent compilation of dossiers based on latest regulatory intelligence screenings and the complete dossier processing throughout the life cycle. The interactive component will arise as we will have a session panel made up of regulators, industry experts and academia. These are the three stakeholders that need to jon forces in order to shape the regulatory environment into one that can embrace AI solutions.

Chair

Rob Williams


Speakers
avatar for Rob Williams

Rob Williams

Senior Director, Regulatory Informatics and Digital Technologies, PharmaLex
Rob is a digital technology professional with two decades of experience in the development of enterprise web-based solutions for global organisations. Rob combines his deep technical experience with business understanding and a client focused approach to deliver maximum benefit to... Read More →


Wednesday February 6, 2019 11:15 - 11:45
Content Hub 3 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

11:15

#CH402: Policy 0070 Submissions – Comparison of Anonymisation Methodologies – Advantages and Disadvantages
Component Type: Session
Level: Intermediate



Learning Objectives

Comparison of anonymisation techniques and assessments; advantages and disadvantages; EMA Policy 0070 Phase I.

Chair

Ingeborg Cil, MSc


Speakers
avatar for Ingeborg Cil

Ingeborg Cil

Lead, Clinical Trial Data Anonymization, Shire Now Part of Takeda
Ingeborg Cil is Associate Director, Clinical Trial Transparency, at Shire Now Part of Takeda. She received her Master of Science in Computer Science from the Technical University Vienna. After working several years as software developer, project manager, supervisor, Ingeborg moved... Read More →


Wednesday February 6, 2019 11:15 - 11:45
Content Hub 4 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

12:00

#CH103: EUPATI Update
Component Type: Session



Chair

Matthew May, MS


Speakers
MM

Matthew May

Programme Coordinator, EUPATI Project, EUPATI


Wednesday February 6, 2019 12:00 - 12:30
Content Hub 1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

12:00

#CH403: Bridging the Gap between Managed Healthcare and Clinical Research
Component Type: Session
Level: Intermediate



Learning Objectives

Strategies for integrating Managed Healthcare organizations into Clinical Research. Challenges to work with Medicare dependent entities. Benefits of incorporating Managed Healthcare organizations in research projects.

Chair

Ves Gitchev, MD


Wednesday February 6, 2019 12:00 - 12:30
Content Hub 4 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

12:00

#S0102: Optimising Paediatric Drug Development in the EU
Component Type: Session

This session is a follow-up to Session 0101 - Optimising Orphan Drug Development in the EU. Different stakeholders will be brought together to discuss how they can contribute to better and more efficient paediatric drug development in Europe. From the current regulatory framework to ways drug developers approach such R&D, speakers will provide different perspectives on the experience so far and how Europe can be an important region to bring innovative treatments to children. A follow-up panel will include paediatric and orphan perspectives from both sessions. efficient paediatric drug development in Europe. From the current regulatory framework to ways drug developers approach such R&D, speakers will provide different perspectives on the experience so far and how Europe can be an important region to bring innovative treatments to children. A follow-up panel will include paediatric and orphan perspectives from both sessions.

Chair

Karl-Heinz Huemer, MD, PhD

Speaker

Panel Discussion
Geneviève Le Visage, PharmD, MSc

Panel Discussion
Camilla Nawrocki, MPharm

Panel Discussion
Dimitrios Athanasiou, MBA

Panel Discussion
Sandra L. Kweder, MD



Speakers
avatar for Dimitrios Athanasiou

Dimitrios Athanasiou

Patient Advocate, WORLD DUCHENNE ORGANIZATION (WDO) , MDA HELLAS
Dimitrios Athanasiou is a PDCO member representing EURORDIS. He holds a BA and an MBA in Financial Management He attended Eurordis Summer School and European Patient Academy (EUPATI) acquiring basic biotech and regulatory knowledge. As a full time patient advocate in DMD, he is a... Read More →
KH

Karl-Heinz Huemer

Clinical Assessor, Scientific Office, Austrian Medicines and Medical Devices Agency (AGES)
PhD (in biology) and MD University of Vienna research at Medical University of Vienna (main area neuroscience) since 2007 assessor at the Austrian Medicines Agency full member in EMA - Paediatric Committee (PDCO) alternate member in EMA - CHMP Scientific Advice Working Party (SAW... Read More →
avatar for Sandra Kweder

Sandra Kweder

Deputy Director, Liaison to the EMA, Office of International Programs, OC, FDA
Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA Office of International Programs. Dr. Kweder previously served for more than a decade as Deputy Director, Office of New Drugs, in FDA’s Center for Drug Evaluation & Research, where she actively led numerous... Read More →
avatar for Camilla Nawrocki

Camilla Nawrocki

Senior Regulatory Project Manager, Zealand Pharma A/S
Camilla Nawrocki has a MScPharm and a Master in Industrial Drug Development from University of Copenhagen and more than 15 years of pharma industry experience from Novo Nordisk, Lundbeck and Shire with solid knowledge about the entire product life cycle and value chain. Camilla has... Read More →
avatar for Geneviève Le Visage

Geneviève Le Visage

Regional Head RA Europe Policy & Liaison, Novartis Pharma AG
Pharmacist by training, with a masters in Science Communication Currently heads the team responsible for regulatory intelligence and policy for the EU for Novartis in Basel, Switzerland, supporting project teams in establishing their strategy for filing in the EU, including for paediatrics... Read More →


Wednesday February 6, 2019 12:00 - 13:15
E1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Regulatory Science
  • Tags Session

12:00

#S0202: How Can the EU Regulatory Network Support Innovation?
Component Type: Session

The session will review the support mechanism of the medicines regulators and HTA bodies for the innovators to enhance innovation. It also will review the new Horizon 2020 STARS program aiming to improve the regulatory knowledge of academic groups.

Chair

Esa Henrik Heinonen, DrMed

Speaker

EMA’s Perspective
Anthony Humphreys, MPharm

What is The EU-Innovation Network?
Esa Henrik Heinonen, DrMed

STARS Project – Approaching Academic Centers
Julia Stingl, DrMed

IMI Projects – Role of a Regulator
Isabelle Bekeredjian-Ding, MD

EU Cooperation on HTA - Today and Tomorrow
Ana-Eva Ampelas, LLM



Speakers
AA

Ana-Eva Ampelas

Head of Unit, Medical products: Quality, Safety, Innovation, European Commission
Anna-Eva Ampelas is Head of Unit for Medical Products: quality, safety, innovation in Unit B4 in DG SANTE, European Commission. In this capacity, she manages files on medicinal products (falsified medicines, clinical trials, shortages, GMP etc); Health Technology Assessments (HTA... Read More →
avatar for Isabelle Bekeredjian-Ding

Isabelle Bekeredjian-Ding

Head of Division of Microbiology, Paul-Ehrlich-Institut (PEI)
Isabelle Bekeredjian-Ding is Head of the Microbiology Division at Paul-Ehrlich-Institut. She is a Medical Microbiologist and Immunologist and Associate Professor at the University of Bonn. She received Medical School training at the University of Heidelberg, Padova (Italy) and Mt... Read More →
avatar for Esa Heinonen

Esa Heinonen

Director, Assessment of Medicinal Products, Finnish Medicines Agency (Fimea)
Dr. Heinonen is a medical doctor with over twenty years of management experience in pharmaceutical R&D (senior VP)especially in the fields of neurology and oncology. He is Adjunct Professor of Drug Development (University of Turku, Finland). He has also over 10 years management experience... Read More →
avatar for Julia Stingl

Julia Stingl

Vice President and Head of Research, Bfarm
Julia C Stingl (formerly Kirchheiner) M.D. is professor of translational pharmacology at the University Bonn Medical Faculty and head of the research division of the Federal Institute of Drugs and Medical Devices. Since 2014 she is Vice President of the institute. Her research mostly... Read More →
avatar for Anthony Humphreys

Anthony Humphreys

Head of Scientific Committees Regulatory Science Strategy, European Medicines Agency, European Union
He is the Head of Scientific Committees Regulatory Science Strategy Division (SciRS). He is responsible for providing leadership in the Agency in the areas of Scientific Committees Coordination and Regulatory Science Strategy in support of delivering the EMRN 2020 Strategy. He chairs... Read More →


Wednesday February 6, 2019 12:00 - 13:15
F2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Translational Medicine
  • Tags Session

12:00

#S0302: Forum on Global Pharmacovigilance
Component Type: Session

In this session a comparison of safety surveillance in the EU and USA, based on experiences with signal management, an outline of authorities’ expectations to PSURs and an update to the WHO´s Smart Safety Surveillance (3S) strategy will be provided.

Chair

Doris Irene Stenver, MD, MPA

Speaker

Comparison of the Management of Safety Signals between EU and USA for 2017
Arpit Vallabhbhai Vachhani, MD

Periodic Safety Reports: What are the Authorities Expectations?
Menno Van Der Elst, PharmD, PhD

Update on the WHO Triple S Initiative
Shanthi Pal, DrSc, MPharm



Speakers
avatar for Menno Van Der Elst

Menno Van Der Elst

PRAC member, Medicines Evaluation Board
Menno van der Elst is PRAC member for the Netherlands. He was trained as community pharmacist and obtained his PhD at Utrecht University at the Department of Pharmaceutical Sciences. Menno joined the MEB in 2007 as pharmacovigilance assessor. He participated in the PhVWP since 2009... Read More →
SP

Shanthi Pal

Group Lead, Medicines Safety, Safety & Vigilance, WHO
Dr S Pal has a Masters in Pharmacy with a PhD in Pharmacology. Been with WHO for nearly 2 decades, and leads the Medicines Safety Programme in WHO, to support pharmacovigilance activities in low and middle income countries and in priority programmes such as HIV, TB, malaria. WHO representative... Read More →
avatar for Doris Stenver

Doris Stenver

Chief Medical Officer, Danish Medicines Agency
Doris joined the Danish Medicines Agency in June 1998, initially as senior medical officer; in 2002 appointed chief medical officer (current position). She was member of the EU Pharmacovigilance Working Party from June 1998 until July 2012. Since July 2012 she has been member of the... Read More →
avatar for Arpit Vachhani

Arpit Vachhani

Senior Drug Safety Physician, APCER Life Sciences
Dr. Arpit is a Physician by training, having done M.D in Pharmacology. He has more than 4 years of experience in Pharmacovigilance. Dr. Arpit is currently working as senior safety physician for aggregate reports at APCER Life Science, Ahmedabad India. His previous PV experience includes... Read More →


Wednesday February 6, 2019 12:00 - 13:15
E2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Pharmacovigilance
  • Tags Session

12:00

#S0402: Where Will Patients Come from in the Future? EHR and Biobanks
Component Type: Session

There is no clinical research without patients who are willing to participate in clinical trials. As long as this paradigm is valid, finding the right patients is a key to success in clinical development. Sometimes one has to apply sophisticated concepts to find eligible patients, but more straightforward access strategies may be available with Biobanks and Electronic Health Records (EHRs). Representatives of both tools will discuss their value and limitations.

Chair

Peter Schueler, DrMed, MD

Speaker

Biobanks – What and Where They Are
Berthold Huppertz, PhD

“Anonymized Identification” Technology and its Use in EHR Clinical Trial Patient Search and Identification
Ian Rentsch, JD

How a Data-Driven Approach Can Lead Difficult to find Pediatrics Sickle Cell Disease Patients into Clinical Trials
Martim Goncalves, MBA

Roundtable: EHR - A Breakthrough in Patient Recruitment? - The View from National Competent Authority
Janet Valentine, PhD

Roundtable: EHR - A Breakthrough in Patient Recruitment? - The Obstacles
Peter Gocke

Roundtable: EHR - A Breakthrough in Patient Recruitment? - The Solutions
Christine Mueller, PhD



Speakers
PG

Peter Gocke

Chief Digital Officer, Charité Berlin
avatar for Martim Goncalves

Martim Goncalves

Global Solutions Manager (R&D), IQVIA
Martim Gonçalves is leading cross-functional projects for the Analytics Center of Excellence in a collaboratively way to find novel, differentiating solutions to challenging and complex problems. In this role, I am passionate about innovation, and new data science solutions at a... Read More →
avatar for Berthold Huppertz

Berthold Huppertz

Chair, Division of Cell Biology, Histology and Embryology, Medical University of Graz
Berthold Huppertz is PhD and professor of cell biology. From 2011 to 2017 he has been director and CEO of Biobank Graz, the largest clinical biobank in Europe with more than 20 million samples. During this time, Biobank Graz was awarded “Research Biobank of the Year” in 2014... Read More →
CM

Christine Mueller

Hospital Engagement Lead, Custodix NV
Christina Mueller holds a PhD in Biomedical Science from the University of Gent, Belgium as a continuation of her undergrad degree in Molecular Biology at the University of St. Andreas, Scotland. She has practical experiences in fundamental research for medication development, in... Read More →
avatar for Ian Rentsch

Ian Rentsch

Chief Executive Officer, Clinerion
Ian Rentsch has over 22 years’ experience in legal corporate affairs, outsourcing management working in large multinational companies including biopharmaceuticals, and more recently, general management experience leading regional clinical teams, CRO business operations and global... Read More →
avatar for Peter Schueler

Peter Schueler

Senior Vice President, Drug Development Neurosciences, ICON plc (CRO)
Peter Schüeler, MD, serves as Senior Vice President, Drug Development Neurosciences, for ICON plc (Germany). He joined ICON as Vice President for Medical Affairs and Drug Safety for Europe, and has authored an eBook about drug development methodology. Dr. Schüeler is Head Lecturer... Read More →
avatar for Janet Valentine

Janet Valentine

Director of Clinical Practice Research Datalink (CPRD), MHRA
Janet Valentine PhD joined the Clinical Practice Research Datalink (CPRD) as Director in 2015. CPRD is the UK Government real world health data research service supporting retrospective and prospective public health and clinical studies. Previously Janet was Head of Population Health... Read More →


Wednesday February 6, 2019 12:00 - 13:15
F1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Clinical Development
  • Tags Session

12:00

#S0502: Creating Value for Patients
Component Type: Session



Chair

Jennifer Burgess, MBA, MPH

Speaker

Bringing Lay Summaries to Fruition - How to Implement Appropriate Processes
Thomas M. Schindler, PhD

Best Practices for Lay Summaries in Global Clinical Trials
Hugo Riu

Enabling Patient Centric Clinical Trials: TransCelerate’s Patient Experience Initiative
Fabian Somers, PhD, MBA, MSc

Patient Engagement Through Patient Centricity
Srinivas Karri, MSc



Speakers
avatar for Jennifer Burgess

Jennifer Burgess

Executive Director of Engagement, TransCelerate BioPharma Inc.
avatar for Srinivas Karri

Srinivas Karri

Senior Director, Clinical Warehousing Cloud Strategy, Oracle Corporation
As an industry strategy lead for clinical data cloud based applications, I help identify, define and create new services to support management of clinical data using cloud based technologies and capabilities. I have over 20 years experience with developing, implementing, selling and... Read More →
avatar for Hugo Riu

Hugo Riu

Quality and Training Director, Welocalize Life Sciences
Quality and Training Director at Welocalize Life Sciences. 20 years of experience in the medical translation industry. During his tenure in the industry, he has worked in several positions, including medical translator and proofreader, project manager, and operations manager. Currently... Read More →
avatar for Thomas Schindler

Thomas Schindler

Head Medical Writing Europe, Boehringer Ingelheim Pharma GmbH & Co.KG
Thomas M. Schindler, PhD (Molecular Physiology). After his post-doc, he went into publishing as a popular science editor and has meanwhile gained some 20 years of experience in both medical affairs and regulatory medical writing. He has a vetted interest in lay language communication... Read More →
FS

Fabian Somers

Senior Clinical Program Director, NewMeds & Bone Clinical Development, UCB Biopharma
Fabian Somers is a seasoned leader with +20 years of experience in the pharmaceutical industry gained in large and middle-size companies in Europe and the USA. Over the years, he has fulfilled different roles and most recently has been working as Sr Clinical Program Director with... Read More →


Wednesday February 6, 2019 12:00 - 13:15
G2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Medical Affairs
  • Tags Session

12:00

#S0602: Incorporation and Acceptance of Real World Evidence in Market Access Discussions – Case Studies
Component Type: Session

The session has the aim to cover important and challenging issues around the concept of RWD. Who needs what? What will different stakeholder be prepared to use and trust when RWD is on the table?

Chair

Niklas Hedberg, MPharm

Speaker

Partnering to Enable Evidence Generation
David Myers

What Do We Do with New Data Sets?
Evert Jan van Lente, MS

How Do Patients Want to be Approached to Contribute to a Better Environment for RWD? Do Patients Experience A Double Role, Sharing Their Own Data and Depending on the Decisions Based on Those Data?
Bettina Ryll



Speakers
avatar for Niklas Hedberg

Niklas Hedberg

Chair EUnetHTA Executive Board, Chief Pharmacist, Dental and Pharmaceutical Benefits Agency, TLV
Niklas Hedberg, MSc, is Chief Pharmacist for the Dental and Pharmaceuticals Benefits Agency (TLV) in Sweden. He is also Chair of the EUnetHTA Executive Board, TLV’s lead partner in EUnetHTA, and has led EUnetHTA WP3 – Evaluation since 2016. Mr. Hedberg has broad experience in... Read More →
EJ

Evert Jan van Lente

Director EU-Affairs, AOK Bundesverband (Federal Insurer)
Mr. van Lente is a health economist and director EU-Affairs of the AOK-Bundesverband, Germany. He is involved in developments in the health sector on European level, especially in pharmaceuticals, medical devices, e- and mHealth. He is based in Brussels and Berlin. The AOK-Group is... Read More →
DM

David Myers

Associate Director Market Access RWE Partnerships, Janssen Pharmaceuticals
David is Associate Director Market Access and Real World Evidence Partnerships, working for Janssen Pharmaceuticals in Stockholm, Sweden. He works in Janssen's research partnership with Karolinska Institutet, as well as other strategic partnerships around the world. He holds a bachelor's... Read More →
avatar for Bettina Ryll

Bettina Ryll

Chair ESMO Patient Advocates Working Group (PAWG), Melanoma Patients
Bettina Ryll, MD/PhD founded the Melanoma Patient Network Europe in 2013 and developed a special interest in patient-centric clinical research and drug development. Bettina’s current areas of focus are Adaptive Licensing/ MAPPS , innovative sustainable healthcare models and patient-centered... Read More →


Wednesday February 6, 2019 12:00 - 13:15
K1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Value and Access
  • Tags Session

12:00

#S0702: Blockchain in Healthcare and Pharma
Component Type: Session

Blockchain is the one of the most talked about technologies of 2017. With the potential exceeding any other to revolutionize the healthcare industry, it is crucial to first understand the nature of blockchain technology, to distinguish the hype from the reality and then to see real-world case studies of how blockchain, combined with other technology such as AI, will be applied to healthcare systems.

Chair

Pascal Bouquet, MSc

Speaker

Panel Discussion
Disa Lee Choun, MBA, RPh

Panel Discussion
Andy Bushell, PhD, MBA

Panel Discussion
Nikolai Constantin Brun



Speakers
avatar for Pascal Bouquet

Pascal Bouquet

Global Head of Technology, Architecture and Digital for the Drug Development, Novartis
Senior technologist and Enterprise Digital Architect, Pascal has more than 20 years of experience leading global IT organizations, building high performing teams, managing Enterprise Architecture teams, leading digital innovation and delivering large scale, global programs. He joined... Read More →
avatar for Nikolai Brun

Nikolai Brun

Director of Division for Medical Evaluation and Biostatistics, Danish Medicines Agency
Degrees from University of Copenhagen, with PhD studies at University of Pennsylvania Background and experience as a practicing physician in the clinical field (Pediatrics) and later in research and development of pharmaceuticals in the Biotech and Pharmaceutical Industry for 17 years... Read More →
avatar for Andy Bushell

Andy Bushell

CEO, OoNiDa, Oonida
Andy has 30+ years experience in discovery, development and commercialization of medicines worldwide. Keynote speaker on Innovation, Universal Health, Non-communicable disease and Digital Advances. Currently Global Program Head for Novartis Pharma AG and President/founding CEO of... Read More →
avatar for Disa Lee Choun

Disa Lee Choun

Director, Head of Innovation, GCSO, UCB Pharma
Disa has years of experience working in technology and innovation especially in the pharmaceutical industry. In her current role as Director Head of Innovation within the Global Clinical Sciences & Operations at UCB, she is responsible for evaluating and piloting innovative solutions... Read More →


Wednesday February 6, 2019 12:00 - 13:15
DIAlogue Space Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Data and Data Standards
  • Tags Session

12:00

#S0802: Driving for Regulatory Excellence in Turkey
Component Type: Session



Chair

Virginia Acha

Basak Yilmaz, MS

Speaker

TITCK’s Road Map to Regulatory Excellence
Oguzhan Koyuncu, MS

Where Do We Stand Now? The Regulatory Review Process of TITCK
Hacer Coskun Cetintas, MPharm

On the Way to Our Goal in Clinical Trials - What is Next?
Nihan Burul Bozkurt, PhD



Speakers
avatar for Virginia Acha

Virginia Acha

Executive Director, Global Regulatory Policy, MSD
Virginia (Ginny) has worked in industry and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She recently joined MSD to lead regulatory policy efforts for innovation that will lead to better... Read More →
NB

Nihan Burul Bozkurt

Head of the Clinical Trials Department, Turkish Medicines and Medical Devices Agency (TITCK)
Nihan Burul Bozkurt received her B.Sc. degree in Pharmacy from Hacettepe University. She holds M.Sc. and Ph.D. degrees in Pharmacology from the same University. After getting her Ph.D. she worked in her own project as a guest researcher in Karolinska Institutet, Alzheimers Disease... Read More →
HC

Hacer Coskun Cetintas

Head of the Medicines Marketing Authorization Department, Turkish Medicines and Medical Devices Agency (TITCK)
I’m Hacer Coskun Cetintas. I’m Head of the Department for Marketing Authorization for Medicines at Turkish Medicines and Medical Devices Agency (TMMDA). I have bachelor degree from Hacettepe University School of Pharmacy and also Master of Science degree on Pharmaceutical Technology... Read More →
avatar for Oguzhan Koyuncu

Oguzhan Koyuncu

Advisor to the President, Turkish Medicines and Medical Devices Agency (TITCK)
Oguzhan Koyuncu is a pharmacist, graduate from Hacettepe University, Faculty of Pharmacy. In the same faculty, he completed his master of science in the area of Pharmaceutical Technology. He is still continuing Regulatory Science PhD. program in Yeditepe University. He has worked... Read More →
avatar for Basak Yilmaz

Basak Yilmaz

Deputy Secretary General, Association of Research Based Pharmaceutical Companies
Basak received her B.Sc degree in Chemical Engineering from Yildiz Technical University. She began to work in the pharmaceutical sector in 2001 and she has an experience and expertise in R&D, Quality and Regulatory. She served as a Regulatory and Market Access Director in the pharma... Read More →


Wednesday February 6, 2019 12:00 - 13:15
K2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Regulatory Science
  • Tags Session

12:00

#S0902: Next Generation Sequencing-Based Comprehensive Genomic Profiling: A Paradigm Shift in Clinical Practice
Component Type: Session

This session will introduce NGS-based Comprehensive Genomic Profiling (CGP) and the clinical relevance and implications of CGP for drug development and clinical practice in the future. Additionally, this session will explore the regulatory environments for NGS and CGP and consider the role of CGP in the context of a regulated learning healthcare ecosystem.

Chair

Benjamin Horbach, MSc

Speaker

An Introduction to NGS and Comprehensive Genomic Profiling (CGP)
Thomas Penz, DrSc

The Clinical Relevance and Implications of CGP for Drug Development and Clinical Practice
Benedikt Westphalen, DrMed

The Role of CGP in the Context of a Regulated Learning Healthcare Ecosystem
Jorge Camarero, PharmD, PhD, MSc



Speakers
avatar for Jorge Camarero

Jorge Camarero

CHMP Alternate, Spanish Agency For Medicines
Jorge Camarero has a broad professional experience in the oncology regulatory field, with specific expertise in the assessment and scientific advice of oncology medicinal products. He is a European Health Authority expert, focused on oncology, with more than 12 years experience in... Read More →
avatar for Benjamin Horbach

Benjamin Horbach

F. Hoffmann-La Roche
Mr. Horbach is Health Systems Strategy Leader for Personalised Healthcare at F. Hoffmann-La Roche AG, Basel, Switzerland. He has led several market access initiatives aiming to enable access to advanced genomic profiling for cancer patients. Mr. Horbach holds degrees in Finance and... Read More →
avatar for Thomas Penz

Thomas Penz

Deputy Head Biomedical Sequencing Facility, CeMM
Thomas Penz studied genetics and microbiology at the University of Vienna. In 2013 he joined the Biomedical Sequencing Facility (BSF) of CeMM and MedUni Vienna which is Austria’s first center of expertise for next generation sequencing in biomedicine. With a dedicated team of staff... Read More →
avatar for Benedikt Westphalen

Benedikt Westphalen

Coordinator Molecular Oncology, University of Munich - Comprehensive Cancer Center
Benedikt Westphalen studied Medicine and Molecular Biology in Hamburg, Philadelphia, New York and Bern. After graduating medical school, he started training in Internal Medicine at the University of Hamburg in 2008. In 2010, Dr. Westphalen joined Columbia University in New York City... Read More →


Wednesday February 6, 2019 12:00 - 13:15
G1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

12:00

#LOT02: How is R&D Being Reflected in Academia vs Industry
Component Type: Session

This session will offer the audience the opportunity to discover the differences and the similarities in regards to R&D in academia vs. industry.

Chair

Eva Shannon Schiffer, MPharm

Speaker

Panelist
Lyudmil Ninov

Industry view on R&D
Wolfgang Bonitz



Speakers
ES

Eva Shannon Schiffer

President, EPSA
Eva Shannon Schiffrer is the European Pharmaceutical Students' Association (EPSA) President for the 2018/2019 mandate. EPSA is an umbrella association of 45 national and local associations from 37 European countries, representing over 100.000 European pharmaceutical students, and... Read More →
WB

Wolfgang Bonitz

Chief Scientific Officer, Novartis Pharma GmbH
avatar for Lyudmil Ninov

Lyudmil Ninov

Project Officer and EPF Youth Group Coordinator, European Patients' Forum (EPF)
EPF Project Officer and EPF Youth Group Coordinator. Lyudmil focuses mainly on: the EC PRO-STEP tender project (EPF-led), Annual Summer Training for Young Patient Advocates Leadership Programme, contributing to H2020 project proposals/calls and day-to-day management of DigitalHealthEurope... Read More →


Wednesday February 6, 2019 12:00 - 13:15
0.96-0.97 (Level 0) Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

12:30

#CH406: Unmet Medical Need Papers
Component Type: Session



Chair

Rick Vreman


Wednesday February 6, 2019 12:30 - 13:00
Content Hub 4 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

13:15

#L2: Lunch in the Exbition Hall
Component Type: Social Event




Wednesday February 6, 2019 13:15 - 15:15
Exhibition Hall Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

13:30

#LS01: Debate: Does the Future Legislative Framework in the EU Need Transformative Legislative change? Or Have We ‘Almost Got It Right’?
Component Type: Session

With a potential re-opening of the Medicines Legislation on the horizon, now is the time to have a top level debate on the state of medicines legislation in the EU.

Chair

Maureen Kenny

Speaker

Debater
Anastassia Negrouk

Debater
Peter W.L. Bogaert, MA

Debater
David Haerry

Debater
Thomas Senderovitz, DrMed, MD



Speakers
avatar for Peter Bogaert

Peter Bogaert

Partner, Covington & Burling LLP
A managing partner of the Brussels office of Covington & Burling, with a broad European life sciences practice. He has detailed regulatory expertise under EU and national laws, handles legislative and other policy assignments and provides strategic advice. Also represents life sciences... Read More →
avatar for David Haerry

David Haerry

Member, European AIDS Treatment Group
David has been involved with health care professionals’ education projects since 2007 and, in 2015, became Secretary General for the Swiss Academic Foundation on Education in Infectious Diseases (SAFE-ID). He has been Work-Package Co-leader and a member of the Executive Committee... Read More →
MK

Maureen Kenny

EXECUTIVE EDITOR, Informa
avatar for Anastassia  Negrouk

Anastassia Negrouk

Head of International Policy Office, DPO, EORTC
Anastassia Negrouk is holding master's degree in Biology, she specialized during 5 years in cellular biology and biochemistry working in a research laboratory focusing on cancer research. She joined EORTC in 2000; Involved in the regulatory since 2003, she took on her current position... Read More →
avatar for Thomas Senderovitz

Thomas Senderovitz

Chair of HMA Management Group; Director General, Danish Medicines Agency
Thomas Senderovitz took over as Director General of the Danish Medicines Agency on 1 April 2016. His career includes more than 20 years working with medicinal products and he has held several senior positions in international biopharmaceutical Companies. He previously worked at the... Read More →


Wednesday February 6, 2019 13:30 - 14:30
DIAlogue Space Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

14:15

#PS05: Oral Poster Session 5 - Translational Medicines and Science & Data and Data Standards Content Hub
Component Type: Session



Speaker

Turn Compliance into Value – Decrease Complexity, Increase Compliance and Reduce Total Costs of Ownership
Romuald Braun, MS, MSc, RAC

An Assessment of Real-World Data, Artificial Intelligence, and their Use in Drug Development
Kenneth Hu, PharmD

Text Mining Discharge Summaries of Hospital Electronic Medical Records to Detect Adverse Drug Reactions
Sreemanee Raaj Dorajoo, PhD



Speakers
avatar for Romuald Braun

Romuald Braun

Vice President, Strategy - Life Sciences, AMPLEXOR Life Sciences
Braun’s 25-year career to-date has been spent across roles related to Compliance, Document Management, Content Management in the Life Sciences industry – both on the client side and in consulting, spanning delivery, sales, project and line manager roles. His experiences bridge... Read More →
avatar for Sreemanee Dorajoo

Sreemanee Dorajoo

Data Analyst, Health Sciences Authority, Singapore
Dr Dorajoo is a Data Analyst at the Health Sciences Authority (HSA), the drug regulatory agency in Singapore. A pharmacist by training, part of his time is devoted to serving the Adverse Event Monitoring Team at HSA, reviewing adverse event reports to detect emerging drug safety signals... Read More →
avatar for Kenneth Hu

Kenneth Hu

Faculty, Rutgers University


Wednesday February 6, 2019 14:15 - 14:45
Content Hub 3 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

14:15

#LOT00: Meet & Greet with Senior Experts
Component Type: Session

Don’t lose the chance to network with senior DIA volunteers and get insights on their career evolution. Ask your burning questions and get advice from DIA Regional Advisory Council members.

Who will you meet:

Vivianne Arencibia, Arencibia Quality and Compliance Associates
Tatyana Benisheva, National Drug Institute, Bulgaria
Gabriele Braeunlich, Bayer Pharma
Emmanuel Chantelot, Celgene
Vicki Edwards, Abbvie
Niklas Hedberg, Chair EUnetHTA Executive Board; TLV
Cordula Landgraf, Swissmedic
Tiia Metiäinen, Lundbeck
Inger Mollerup, Novo Nordisk
Mira Pavlovic-Ganascia, MDT services
Peter Schueler, ICON
Maren von Fritschen, Addon Pharma (RAC Chair)
Frank Wartenberg, IQVIA


Wednesday February 6, 2019 14:15 - 15:15

14:45

#CHS04: Navigating the Regulatory Landscape for Safety Reporting in Clinical Trials: Key Principles, Best Practices, and Upcoming Automation
Component Type: Session



Chair

Beata Kolon


Speakers
avatar for Beata Kolon

Beata Kolon

Director Medical Safety Services, ICON
Beata Kolon, is Molecular Biologist and PV expert by dedication and passion. In 2007 she joined Roche as Drug Safety Associate in the UK, where she started her career in PV. Later on, she joined ICON Clinical Research in the UK. She got involved in a variety of PV activities in oncology... Read More →


Wednesday February 6, 2019 14:45 - 15:15
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

15:15

#CH201: Recent Developments and Possibilities in Using CPRD as a ‘Real World Data Source’
Component Type: Session

For more than 30 years, electronic health records (EHRs) provided by CPRD have supported a range of drug safety and epidemiological studies impacting on health care and producing 2000 publications. Recently CPRD launched a real world clinical research service, designed to increase study efficiencies and reduce costs though EHR-based protocol design, patient recruitment and clinical trials management.

Chair

Janet Valentine, PhD


Speakers
avatar for Janet Valentine

Janet Valentine

Director of Clinical Practice Research Datalink (CPRD), MHRA
Janet Valentine PhD joined the Clinical Practice Research Datalink (CPRD) as Director in 2015. CPRD is the UK Government real world health data research service supporting retrospective and prospective public health and clinical studies. Previously Janet was Head of Population Health... Read More →


Wednesday February 6, 2019 15:15 - 15:45
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

15:15

#CH404: EMA Policy 0070 - Arguing for a Pro-Active Anonymisation Process and External Validation of Identification Risk and Utility
Component Type: Session
Level: Intermediate



Chair

Friedrich Maritsch, PhD


Speakers
avatar for Friedrich Maritsch

Friedrich Maritsch

Data Anonymization Lead, Shire Now Part of Takeda
Friedrich Maritsch, Sr. Director, Data Anonymization Lead at Shire’s (now part of Takeda’s) Clinical Trial Transparency Group, holds a PhD from the University of Vienna in Austria and has over 25 years of experience in the pharmaceutical industry, working in various capacities... Read More →


Wednesday February 6, 2019 15:15 - 15:45
Content Hub 4 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

15:15

#S0103: The Regulatory Role in EU Public-Private Partnerships (PPPs)
Component Type: Session

This forum will discuss how regulatory contribution to EU public-private partnerships like the Innovative Medicines Initiative (IMI) was critical for its outcomes and for the advancement of EU regulatory science. Panelists will reflect on past and current achievements, while looking beyond 2019 and towards the new Framework Programme 9 (Horizon Europe), reflecting on possible partnerships that can bring added value to drug development and healthcare in the EU and globally.

Chair

João Duarte, MPharm, MSc

Speaker

Panel Discussion
Magda Chlebus, MA

Panel Discussion
Solange Corriol-Rohou, DrMed, MD, PhD

Panel Discussion
David Haerry



Speakers
avatar for João Duarte

João Duarte

Associate Director, Regulatory Intelligence, Alexion Pharmaceuticals
João Duarte received his Master degree in Pharmaceutical Science in 2011 from the Faculty of Pharmacy of the University of Lisbon. He is currently Associate Director for Europe Regulatory Policy & Intelligence at Takeda, based in London, where he is responsible for intelligence and... Read More →
MC

Magda Chlebus

Executive Director Science Policy & Regulatory Affairs, EFPIA
Magda Chlebus is Executive Director Science Policy & Regulatory Affairs at the European Federation of Pharmaceutical Industries and Associations (EFPIA), representing the R&D-based pharmaceutical industry in Europe. | Magda and her team are in charge of following policy and legislative... Read More →
avatar for Solange Corriol-Rohou

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, Europe, Astrazeneca Research & Development
Pulmonologist and immuno-allergologist by training, Solange joined AstraZeneca R&D in 2004. Moving from the French Medicines Agency and hospital to Industry, she has gained strategic experience in drug development. As the chair of the EFPIA Clinical Development Expert Group, she has... Read More →
avatar for David Haerry

David Haerry

Member, European AIDS Treatment Group
David has been involved with health care professionals’ education projects since 2007 and, in 2015, became Secretary General for the Swiss Academic Foundation on Education in Infectious Diseases (SAFE-ID). He has been Work-Package Co-leader and a member of the Executive Committee... Read More →


Wednesday February 6, 2019 15:15 - 16:15
E1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Regulatory Science
  • Tags Session

15:15

#S0203: Precision Medicine: Gene-Editing, Advance Therapies and Personalised Medicine
Component Type: Session

Precision medicine is the present and future of tailored therapies. This session covers 3 important aspects of precision medicine: 1) Precision in genome editing using e.g. Crisp/Cas technology allows us to modify cells and use them to treat cancer, infectious disease and hematological conditions. 2) With precision medicine, treatment choice and benefit-risk assessment will have to rely on new and more individualised methods, such as generalised pairwise comparisons of patient outcomes. 3) Genomics on a population scale may be used to identify individual disease risks and suitability of preventive measures, even before the onset of disease.

Chair

Klaus Cichutek, PhD

Speaker

Overview of Current Gene Editing Landscape
Tatiana Anna Reimer, PhD

The Future of Personalised Medicine – Exploring the Successes and Challenges
Kristiina Rosin

From Precision to Personalised Medicine: Generalised Pairwise Comparisons as a Tool to Individualise Treatment Choices
Everardo Saad, MD



Speakers
avatar for Klaus Cichutek

Klaus Cichutek

President, Paul-Ehrlich-Institut
Prof. Dr. Klaus CICHUTEK is the President of the Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, in Germany. PEI is a senior federal agency reporting to the German Federal Ministry of Health and member of the network of the European regulatory authorities united... Read More →
avatar for Tatiana Reimer

Tatiana Reimer

Regulatory Affairs Strategist, Bayer
Tatiana Anna Reimer is a Global Regulatory Strategist (GRS) at Bayer AG. As GRS, Tatiana is responsible for a regulatory strategy of development and marketed products in ophthalmic, haemophilia and pulmonary diseases. In addition, she is providing operational and strategic expertise... Read More →
avatar for Kristiina Rosin

Kristiina Rosin

Regulatory Policy & Intelligence Manager, Abbvie Ltd
Kristiina is a Regulatory Policy and Intelligence Manager at AbbVie Ltd with a focus on medical devices and personalised medicine in the EU. Prior to joining AbbVie in 2014 Kristiina held labelling and regulatory positions at Pfizer and Alltech. Kristiina holds a BSc(Hons) degree... Read More →
ES

Everardo Saad

Medical Director, IDDI
Everardo Saad is a medical oncologist with a special interest in clinical-trial methodology. He graduated in Medicine and trained in Internal Medicine in Sao Paulo, Brazil, and pursued a fellowship in Medical Oncology at the University of Texas M.D. Anderson Cancer Center, in Houston... Read More →


Wednesday February 6, 2019 15:15 - 16:15
K2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Translational Medicine
  • Tags Session

15:15

#S0303: The New EudraVigilance System: One Year After
Component Type: Session



Chair

Margaret Anne Walters

Speaker

Experience with Reporting and Accessing ICSRs in EV
Margaret Anne Walters

NCA Perspective
Rory Littlebury

Industry Experience with Signalling in EV
Christiane Michel, DrMed, MSc

Panel Discussion
Gaby L. Danan, MD, PhD



Speakers
avatar for Gaby Danan

Gaby Danan

Pharmacovigilance Expert, NA
Gaby Danan, MD, PhD, was the EU Qualified Person for Pharmacovigilance for Sanofi until his 2010 retirement. He has served on the Council for International Organizations of Medical Sciences and International Council on Harmonisation Expert Working Groups, especially as the European... Read More →
avatar for Rory Littlebury

Rory Littlebury

Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA)
Rory has ten years experience working at the MHRA, including working within Licensing and Pharmacovigilance Divisions prior to taking on a Pharmacovigilance Inspector role. Rory’s experience includes engagement as a regulator with a variety of stakeholders, from multi-national pharma... Read More →
avatar for Christiane Michel

Christiane Michel

Global Head Safety Signal Detection, Novartis Pharma AG
With more than 25 years of experience in Pharmacovigilance, Christiane is currently the Global Head of Safety Signal Detection & MedDRA Query Mgmt. at Novartis, Basel, Switzerland. She was trained as a medical doctor in Frankfurt, Germany and obtained her MSc in Epidemiology and Biostatistics... Read More →
avatar for Margaret Walters

Margaret Walters

Deputy EU Qualified Person for Pharmacovigilance, Merck, Sharp & Dohme Ltd
With 10 years in research and 30 in safety, Margaret is currently the Deputy EU Qualified Person for Pharmacovigilance at MSD Ltd. Activities include input to the EFPIA PV EWG, ICH, MedDRA (pre-ICH), the EMA EudraVigilance Steering Committee and the EWG, plus authoring papers on parasitology... Read More →


Wednesday February 6, 2019 15:15 - 16:15
E2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Pharmacovigilance
  • Tags Session

15:15

#S0403: Change is Coming… Getting the Questions Right in Clinical Development
Component Type: Session

The need for greater clarity in the articulation of the scientific questions to be answered with randomised clinical trials has recently resulted in regulations that aim at the development of clear scientific questions as a prerequisite of adequate study design and analysis. The session will discuss challenges and opportunities for clinical development both for the evaluation of efficacy and safety as well as implications on benefit-risk evaluations and product labeling.

Chair

Jürgen Kübler, PhD

Speaker

Getting the Questions Right in Efficacy
Wolfgang Kothny, MD

Getting the Questions Right in Safety
Reinhard Fescharek, MD

Implications on Benefit-Risk and Labelling
Robert Hemmings, MS, MSc



Speakers
RF

Reinhard Fescharek

Vice President, CSL Behring GbmH
avatar for Robert Hemmings

Robert Hemmings

Statistics and Pharmacokinetics Unit Manager, Medicines and Healthcare products Regulatory Agency (MHRA)
Rob has been with MHRA for 16 years and heads up the team of statisticians and pharmacokineticists. Much of Rob’s time is spent educating colleagues in the importance and artistry of clinical trial statistics; their use in proof and in obfuscation. Rob is a co-opted member of the... Read More →
avatar for Wolfgang Kothny

Wolfgang Kothny

Global Head Clinical Sciences, Novartis Pharma
Dr. Wolfgang Kothny is a physician who did his clinical training in the department of cardiology at the University Munich before joining the industry in 1999. Wolfgang joined Novartis in 2007 and currently is holds the Position of Global Head Clinical Sciences. Before that, he was... Read More →
avatar for Jürgen Kübler

Jürgen Kübler

Owner, QSciCon
Dr. Kübler has over 25 years of experience in the pharmaceutical industry. He has published in statistical and scientific journals, regularly gives scientific - presentations and organized various sessions at scientific conferences. He has a Masters and PhD in Statistics from the... Read More →


Wednesday February 6, 2019 15:15 - 16:15
F1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Clinical Development
  • Tags Session

15:15

#S0503: Medical Functions Contribution to Benefit-Risk Assessment
Component Type: Session

Machine Learning, Artificial Intelligence and Blockchain are just some of the technologies finding applications in healthcare. In this session, we will focus on a few of the challenges and exciting advancements enabled by computer- based data management.

Chair

Lisa Beth Ferstenberg, MD

Speaker

Challenges in Post-Marketing Benefit Risk Assessment
Simon Ingate, PhD, MBA

Blockchain in Clinical and Safety Data Management
Kate Gofman, MD, PhD

Factbox For Benefit Risk Analysis
Frederic Bouder, PhD

A Mobile App for Assessing Patient Risk
Ravi Gopalakrishnan, MBA, MS



Speakers
FB

Frederic Bouder

Professor in Risk Management, University of Stavanger
Frederic Bouder is Assistant Professor at Maastricht University in the Department of Technology and Society Studies and Research Associate at King's College London. For over ten years he has developed policy oriented research on risk communication and risk regulation. Frederic has... Read More →
LF

Lisa Ferstenberg

Principal Patient Safety Physcian, AstraZenca
KG

Kate Gofman

Patient Safety Physician, AstraZeneca
RG

Ravi Gopalakrishnan

Head of Digital Platform and Applications, AstraZeneca
Ravi is based in San Francisco and currently leads the Digital /AI Platform and Applications team at Astrazeneca. Prior to joining AZ Ravi was CTO of Alivecor , a Digital Health Startup . Prior to that Ravi was CTO of Barnes and Noble where he led the Product Strategy , Development... Read More →
avatar for Simon Ingate

Simon Ingate

Principal Consultant (Director), Huron Consulting Group Ltd
Simon Ingate is a Principal Consultant at Huron Consulting Group (Formerly Pope Woodhead) where he develops and implements risk management/minimisation (RM) strategy and programmes. Simon leads teams developing new approaches for disseminating and evaluating risk minimisation measures... Read More →


Wednesday February 6, 2019 15:15 - 16:15
G2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Medical Affairs
  • Tags Session

15:15

#S0603: Value Assessment of Combinations in Oncology (or others): Questions and Steps toward Practical Solutions
Component Type: Session

The panel will discuss likely solutions for allowing patients to get access to combination drugs in oncology in a fast and sustainable manner. Panellists will also describe positive developments and highlight what they see as practical ways to advance the debate on this critical matter for the treatment of oncology.

Chair

Meni Styliadou

Speaker

Panelist
Francis Arickx

Panelist
Fiona Carlin

Panelist
Michael Schroter, PhD, MBA

Panelist
Timothy Wilsdon, MS



Speakers
avatar for Francis Arickx

Francis Arickx

Head of the Directorate Pharmaceutical Policy, National Institute for Health and Disability Insurance (RIZIV-INAMI)
Francis Arickx is head of the directorate Reimbursement of Medicines and Pharmaceutical Policy within the Health Care Department at the National Institute for Health and Disability Insurance (NIHDI RIZIV/INAMI) in Belgium. He manages administrative and scientific assessments, and... Read More →
FC

Fiona Carlin

Partner, Baker McKenzie
MS

Michael Schroter

Founding Partner, Viopas
Michael is a managing partner at Viopas, a venture capital and asset management firm investing in privately held and listed companies with a sustainable healthcare focus. As such Viopas favours investments in solutions which deliver cost-effective and improved clinical outcomes. Prior... Read More →
MS

Meni Styliadou

VP Government Affairs & Public Policy, Europe & Canada, Takeda
TW

Timothy Wilsdon

Principal, Charles River Associates International


Wednesday February 6, 2019 15:15 - 16:15
K1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Value and Access
  • Tags Session

15:15

#S0703: The Digital Transformation of Clinical Trials and its Regulatory Implications – What are the Challenges?
Component Type: Session

Digital technology and novel approaches to clinical trial conduct have the potential to simplify the clinical trial process to become more patient-centric. What are the regulatory challenges and hopefully solutions for using these tools in clinical trials of the future?

Chair

Mireille Muller, DrSc, PhD, MSc

Speaker

Challenges Using Digital Tools in Clinical Research
Nitharna Sivarajah

FDA View
David Martin, MD, MPH

The Importance of Software and Apps in Healthcare – Regulatory Considerations
Maria Isabel Manley, LLM



Speakers
avatar for Maria Manley

Maria Manley

Partner, Head of the UK Life Sciences, Sidley Austin LLP
Marie advises on a broad spectrum of matters, both contentious and non-contentious, that arise in the conduct of a bio pharmaceutical business. Marie represents pharma companies before UK and EU institutions (EMA, MHRA, NICE, PMCPA DOH and the European Commission). Marie is Chairperson... Read More →
avatar for David Martin

David Martin

Associate Director, RWE Analytics, Office of Medical Policy, CDER, FDA
David Martin is the Associate Director for Real World Evidence Analytics, Office of Medical Policy, FDA Center for Drug Evaluation and Research. He oversees demonstration projects intended to support the agency’s evaluation of real world evidence, reviews real world evidence submissions... Read More →
avatar for Mireille Muller

Mireille Muller

Regulatory Policy Director, Novartis Pharma AG
Mireille Muller Ph.D. has over 19 years of experience in regulatory affairs at the global level, including policy, benefit-risk research, drug development focused in clinical research. Special interest in early development, scientific advice, and technology-enabled clinical trials... Read More →
NS

Nitharna Sivarajah

Pharmacovigilance Information Coordinator - Direct Reporting lead, Medicines and Healthcare products Regulatory Agency
Nitharna graduated in Natural Sciences at the University of Cambridge. She joined the Medicines and Healthcare products Regulatory Agency (MHRA) in 2015 and swiftly built her knowledge in pharmacovigilance across a range of roles, from case processing to signal management. As a Pharmacovigilance... Read More →


Wednesday February 6, 2019 15:15 - 16:15
F2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Data and Data Standards
  • Tags Session

15:15

#S0803: Updates from the Middle East Region: Key Insights from Agencies & Industry on the Regulatory Environment, Opportunities and the Challenges; Sharing Best Practices of Reliance Model Implementation
Component Type: Session

This session is an opportunity to hear from leading regional health authorities about their role in the region, their vision for the future and the roadmap to achieve that vision. The session will also hear about the hurdles and opportunities for both industry and the health authorities. The presentations will be followed by a Q & A session taking questions from the audience.

Chair

Greg Jordinson, MSc

Speaker

Panellist
Hassaan S Alwohaibi

Panelist
Inas Chehimi



Speakers
avatar for Hassaan S Alwohaibi

Hassaan S Alwohaibi

Executive Director of Regulatory Affairs Directorate, Saudi Food and Drug Authority
ALWOHAIBI holds a bachelor degree in Pharmacy and an MBA. Started his profession in 2001 as in-patient Pharmacist. Then a Medical Application Analyst. Then he joined Saudi Food and Drug Authority in 2007. He held different departments, and currently as the Executive Director of Regulatory... Read More →
avatar for Inas Chehimi

Inas Chehimi

Head DRA Middle East & North Africa, Novartis Pharma Services AG
Holder of Pharmacy diploma, and Master in EU and International Regulation and Healthcare Laws. Currently heading the regulatory department for MENA region in Novartis. She has 15 years’ experience and expertise in the European and Emergent markets regulations; worked for various... Read More →
avatar for Greg Jordinson

Greg Jordinson

Associate Director, Global Regulatory Affairs, Janssen R&D


Wednesday February 6, 2019 15:15 - 16:15
G1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Regulatory Science
  • Tags Session

15:15

#S0903: Histology-Independent Indications
Component Type: Session

Biological drivers that define cancer course across anatomical sites and histologies offer an opportunity to select populations sensitive to specific drugs based on those drivers, independently of the specific site or histology. The FDA regulatory approvals of the first medicines in 2017 marked an important milestone that a cancer treatment may be approved based on a common biomarker rather than the anatomic location in the body where the tumor originated, and therefore established a precedent for histology-independent labels. With increasing accessibility to genetic analysis tools such as next-generation sequencing, this type of personalized therapy has become a reality, both during clinical development and in clinical practice. This session aims to provide an exchange of views from different stakeholders about situations where a site and histology-independent clinical development might be a viable option and the associated challenges in terms of drug development, benefit-risk evaluation and health-technology assessment. A second part of the discussion mainly focusing on challenges for the value assessment of these drugs will be held in session 0606.

Chair

Chitkala Kalidas

Speaker

Panelist
Claus Bolte

Panelist
Sophie Cooper

Panelist
Mike Holmes

Panelist
Amy McKee

Panelist
Daniela Melchiorri



Speakers
CB

Claus Bolte

Head of Authorisation, Swissmedic
avatar for Sophie Cooper

Sophie Cooper

Scientific Adviser, National Institute for Health and Care Excellence (NICE)
Sophie Cooper is currently a Scientific Adviser in the Science Policy and Research programme at NICE, following several years’ experience in NICE's Technology Appraisals programme. Her role involves developing Institute responses to science policy issues and undertaking and commissioning... Read More →
MH

Mike Holmes

Associate Vice President, Global Medical Affairs Oncology, MSD
CK

Chitkala Kalidas

VP and Head Oncology Regulatory Affairs, Bayer
AM

Amy McKee

Deputy Director FDA/Oncology Center of Excellence, FDA
DM

Daniela Melchiorri

Member CHMP, University of Roma


Wednesday February 6, 2019 15:15 - 16:15
DIAlogue Space Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

15:15

#LOT04: Value and Access
Component Type: Session

Market access as a function has been growing in importance over the last decade. This trend is expected to accelerate given the pace of change across all aspects of the healthcare value chain (e.g. informatics, comprehensive diagnostic, new medicine technology, increasing cost pressure, personalisation). In this session we will start with where market access as a function is coming from and where we expect it to be heading and conclude with the new capabilities that would needed to be successful.

Chair

Patrick Gassenbauer

Speaker

Speaker
Nicole Waser, MA



Speakers
avatar for Patrick Gassenbauer

Patrick Gassenbauer

QA Specialist, MSD Sharp & Dohme GmbH
avatar for Nicole Waser

Nicole Waser

Principal, Boston Consulting Group
Since joining BCG, Nicole has been working with multiple international Healthcare clients. Her work has covered a broad range of topics in Market Access, Strategy, Operations/Regulatory and Organizations. In Market Access, Nicole has supported projects in the area of pricing, integrated... Read More →


Wednesday February 6, 2019 15:15 - 16:15
0.96-0.97 (Level 0) Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

15:15

#SP01: Nanomedicines and Nanosimilars – Implications for Regulators, Payers and Prescribers
Component Type: Session

Nanomedicines have been gaining increasing attention in academia and research and over the past twenty years due to the potential they can offer in opening up new or improved therapeutic opportunities. Nanomedicines are however highly complex. Due to their size, they different from small molecules as their properties cannot be fully characterised and minor changes in manufacturing can affect size and/or morphology influencing their quality, biological properties and therapeutic profiles. In the absence of a specific regulatory pathway and legal definition, this workshop will discuss the appropriateness of the current regulatory approval process for nanomedicines and their follow-on products and analyse the potential implications for regulators, payers, physicians and ultimately patients. **This is an invitation-only workshop sponsored by Vifor. For further information please contact DIA.

Chair

Hubert G. M. Leufkens, PharmD

Speaker

Regulatory Considerations for the Approval of Nanomedicines and Nanosimilars Regulatrory Considerations for the Approval of Nanomedicines and Nanosimilars
Beatriz Silva Lima, PharmD, PhD

Clinical Perspective of the Potential Implications of Nanosimilars What are Nanomedicines and How Do They Differ from ‘Traditional’ Small Molecules?
Gerrit Borchard



Speakers
avatar for Hubert Leufkens

Hubert Leufkens

Professor, Pharmaceutical Policy and Regulatory Science, Utrecht University
Hubert (Bert) G. Leufkens is professor of Pharmaceutical Policy and Regulatory Science at Utrecht University. He is research and policy-wise active at several (inter)national platforms on innovation, drug safety, pharmaceutical policy and regulatory science (e.g. past-member EMA Pharmacovigilance... Read More →
avatar for Beatriz Silva Lima

Beatriz Silva Lima

Professor of Pharmacology; NDA Advisory Board, NDA Advisory Services Limited
i) Coordinates the Group of Pharmacological Sciences of the iMed.ULisboa, ii) for 20 years acted as expert in nonclinical and regulatory science at Infarmed, Portugal and EMEA, UK iii) has been (end July 2012) member of CHMP, CAT and SAWP and Chair of Safety Working Party and EU Co-Deputy... Read More →
avatar for Gerrit Borchard

Gerrit Borchard

University of Geneva
Gerrit Borchard is a licensed pharmacist and obtained his Ph.D. in pharmaceutical technology from the University of Frankfurt. After holding several academic posts at Saarland University (DE) and at Leiden University (NLD), he joined Enzon Pharmaceuticals, Inc. (USA) as Vice President... Read More →


Wednesday February 6, 2019 15:15 - 16:45
0.11-0.12 (Level 0) Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

15:45

#CH202: Collaborating to Solve the Industry’s Toughest Challenges: Maximizing the Regulator-Sponsor Relationship
Component Type: Session
Level: Basic



Chair

Christine Mayer-Nicolai, PharmD


Speakers
CM

Christine Mayer-Nicolai

Global Head, Global Regulatory and Scientific Policy, EMD Serono
Pharmacist with over 19 years experience in RA, including working for more than 7 years for BPI (German Industry Association), with Merck (now Merck Serono) since 2002/responsible for Regulatory & Scientific Policy Europe


Wednesday February 6, 2019 15:45 - 16:15
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

15:45

#CH405: Aligning expectations for product label terminology: disease modification in neurodegenerative disorders as a case example
Component Type: Session
Level: Intermediate



Chair

Anne Vinther Morant, PhD, MSc


Speakers
avatar for Anne Morant

Anne Morant

Senior Specialist, Regulatory Science & Advocacy, H. Lundbeck A/S
Anne Vinther Morant is a Senior Specialist in Regulatory Science & Advocacy at H. Lundbeck A/S. Since 2008 she has worked in various functions within regulatory strategy and regulatory science with focus on development of medicines to treat psychiatric and neurologic diseases. Anne... Read More →


Wednesday February 6, 2019 15:45 - 16:15
Content Hub 4 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

16:15

#CB3: Coffee Break in the Exhibition Hall
Component Type: Social Event




Wednesday February 6, 2019 16:15 - 16:45
Exhibition Hall Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

16:15

#PS06: Oral Poster Session 6 - Clinical Development & Pharmacovigilance Content Hub
Component Type: Session



Speaker

Could we do without RCTs? The emergence of single-arm studies as a basis for approval, a meta epidemiologic study
Theo Blaise, MPharm

ClinLine.ru – the first Russian clinical trial platform for Patients, Investigators, Sponsors and CRO
Oksana Karavaeva

Quality Assessment of Published Pharmacogenetic Association in Randomized Clinical Trials, a Systematic Review
Julie Quemeneur, MSc



Speakers
TB

Theo Blaise

Pharmacy resident - Master degree, Universite Claude Bernard Lyon
OK

Oksana Karavaeva

Director of Clinical Operations, IPHARMA LLC
JQ

Julie Quemeneur

Pharmacy and Master 2 Clinical Evaluation Student, Claude Bernard University Lyon 1


Wednesday February 6, 2019 16:15 - 16:45
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

16:45

#CH303: Repurposing - Working Together on New Uses for Old Drugs
Component Type: Session
Level: Intermediate

Drug repurposing is the process of identifying new uses for existing medicines in indications outside the scope of the original approved product information. Drug repurposing constitutes a dynamic field of drug development that can offer real benefits to patients. More and more stakeholders are involved in the debate on how repurposing can be best enabled, including academics, patients groups, the European Commission and the pharmaceutical industry. Local initiatives in some countries such as the UK have started to identify possible frameworks to improve access to repurposed medicines for patients. Using case studies, this session will present in an interactive manner what repurposing can be in practice, and the roles the various stakeholders can play. Attendees will get a better understanding of the key aspects that must be taken into consideration to enable repurposing in ways which benefit patients with medicines supported with robust data.

Chair

Sheuli Porkess, MD, MRCP, FFPM


Speakers
SP

Sheuli Porkess

Deputy Chief Scientific Officer, ABPI
Dr Sheuli Porkess is the Deputy Chief Scientific Officer at the Association of the British Pharmaceutical Industry. Sheuli’s career began in clinical medicine in the NHS and subsequently has included a number of medical leadership roles at a national, regional and international... Read More →


Wednesday February 6, 2019 16:45 - 17:15
Content Hub 3 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

16:45

#S0104: Evidence Generation as a Continuum: Can We Benefit from Advice?
Component Type: Session
Level: Intermediate

We are generating new evidence about medicines in an ever more continuous cycle, with new sources and standards emerging across the globe. But how do decision makers use this evidence and do these assessments align over time? In this session, we look across the lifecycle of a medicine to explore evidence generation at different points in time and from different stakeholder perspectives. We ask participants to consider how scientific advice and assessments processes can help companies, healthcare systems and patients to navigate this changing horizon for evidence and assessment. How can we optimize the regulatory system to meet the challenges of tomorrow? Do we need new processes, guidelines or technologies?

Chair

Virginia Lee Acha, PhD, MSc

Speaker

Evidence Generation as a Continuum: Can We Benefit from Advice?
Isabelle Stoeckert, PharmD

Post-Licensing Evidence Generation: The Role for the Regulator
Peter Mol, PhD, RPh

Post-Launch Evidence Generation: EUnetHTA Pilot and the Implications for Value Assessment
Irena Guzina, PharmD, MPH, MSc

Evidence Generation for Medicines: How Does this Support Patients?
François Houyez



Speakers
avatar for Peter Mol

Peter Mol

Member SAWP, Principal Clinical Assessor, Dutch Medicines Evaluation Board & University Medical Center Groningen
Peter Mol is a principal assessor at the Dutch Medicines Evaluation Board and a member (vice chair) of EMA’s Scientific Advice Working Party. He is chair of the EMA Cross-Committee Task force on Registries. He is also an assistant professor at the University Medical Center Groningen... Read More →
avatar for Irena Guzina

Irena Guzina

Scientific Project manager, HAS
Irena Guzina is a Pharmacist with a Master degree in Quality Control and Public Health. She has joined HAS in 2011, where she is working as Project manager at the Department for the Assessment of Medical Procedures. Moreover, Irena Guzina is also part of HAS EUnetHTA team. She is... Read More →
avatar for Virginia Acha

Virginia Acha

Executive Director, Global Regulatory Policy, MSD
Virginia (Ginny) has worked in industry and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She recently joined MSD to lead regulatory policy efforts for innovation that will lead to better... Read More →
avatar for François Houyez

François Houyez

Treatment Information and Access Director, Health Policy Advisor, European Organisation for Rare Diseases (EURODIS)
François Houÿez is working at the European Organisation for Rare Diseases EURORDIS where he is Director of Treatment Information and Access, Policy Advisor. He has always been working as a patient advocate since the early 90s, first in the HIV/AIDS advocacy, and in rare diseases... Read More →
avatar for Isabelle Stoeckert

Isabelle Stoeckert

Head Regulatory Affairs Europe Middle East Africa, Bayer AG
Dr. Isabelle Stoeckert is Vice President and Head Regulatory Affairs Europe Middle East Africa at Bayer AG. With more than 20 years of experience in Regulatory Affairs she held several leading positions in a wide area of Regulatory and Scientific Affairs matters. Such as Vice President... Read More →


Wednesday February 6, 2019 16:45 - 18:00
DIAlogue Space Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Regulatory Science
  • Tags Session

16:45

#S0204: Patient Preferences – The Science of Tomorrow
Component Type: Session

The science of patient preferences is evolving rapidly. Close interactions between patients, researchers and decision makers show how a new approach to support medicinal development can be established.

Chair

Conny Berlin, MS

Speaker

Rare Disease Patients in Dialogue with Regulators and HTA Bodies: Patient Views
Rocco Falchetto, PhD

IMI PREFER: What Do We Want to Learn from Case Studies?
Ardine De Wit

Preference Elicitation in at Risk Individuals of Rheumatoid Arthritis – an IMI PREFER study
Christine Radawski, MPH



Speakers
avatar for Conny Berlin

Conny Berlin

Global Head, Quantitative Safety and Epidemiology, Novartis Pharma AG
Conny Berlin leads the department Quantitative Safety and Epidemiology at Novartis Pharma AG. Her responsibilities include supervising a team of statisticians and epidemiologists, providing epidemiology support for all clinical programs and promoting a quantitative safety culture... Read More →
avatar for Rocco Falchetto

Rocco Falchetto

President, International Porphyria Patient Network
Rocco Falchetto is president of the Swiss Society for Porphyria and the International Porphyria Patient Network, two associations representing the interests of patients affected by porphyria, a class of rare to ultra-rare diseases caused by intoxication-type inborn errors of heme... Read More →
avatar for Christine Radawski

Christine Radawski

Benefit Risk Scientist, Eli Lilly
Christine (Chris) Radawski, is a research scientist in the Benefit-Risk (B-R) management group at Lilly where she is responsible for providing B-R assessment support across the portfolio. Since 2013 she has been involved in guiding teams through the application of a systematic method... Read More →
avatar for Ardine De Wit

Ardine De Wit

Associate Professor of HTA, University Medical Center Utrecht


Wednesday February 6, 2019 16:45 - 18:00
G1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Translational Medicine
  • Tags Session

16:45

#S0404: Study Design and Innovative Statistics
Component Type: Session

Having “got the questions right” (Session 0403 Change is Coming… Getting the Questions Right in Clinical Development), trial designs and analytical approaches are needed that are able to give reliable answers to those questions while being efficient in terms of costs and burdens to patients and the healthcare system. This session will explore novel approaches that are working in practice.

Chair

Robert Hemmings, MS, MSc

Speaker

Innovation in Clinical Trial Design – Why Embracing Novel Approaches is Important and Where We Go from Here
Chrissie Fletcher, MSc

New Precision R&D Models in Oncology – Complex Clinical Trials to Investigate Histology-Independent Indications
Sacha Wissink, PhD

Adaptive Trial Designs: Delivering the Unicorn of Clinical Trials in the UK
Matt Cooper, PhD

Panel Discussion
Kirsty Wydenbach, DrMed, MSc



Speakers
avatar for Matt Cooper

Matt Cooper

Business Development and Marketing Director, NIHR Clinical Research Network
Matt has been Business Development & Marketing Director at the Clinical Research Network Coordinating Centre since 2014, having been part of the Network structure for a decade. In a previous roles he was a member of the leadership team of the National Cancer Research Network and before... Read More →
avatar for Chrissie Fletcher

Chrissie Fletcher

Executive Director, Biostatistics in Global Biostatistical Science, Amgen Ltd
Chrissie is an Executive Director Biostatistics in Global Biostatistical Science at Amgen. She is the Global Biostatistics TA Head for Cardiovascular, Metabolic, Neuroscience, Bone, Inflammation and Nephrology disease areas, the EU Regional Head for Biostatistics and leads a Health... Read More →
avatar for Robert Hemmings

Robert Hemmings

Statistics and Pharmacokinetics Unit Manager, Medicines and Healthcare products Regulatory Agency (MHRA)
Rob has been with MHRA for 16 years and heads up the team of statisticians and pharmacokineticists. Much of Rob’s time is spent educating colleagues in the importance and artistry of clinical trial statistics; their use in proof and in obfuscation. Rob is a co-opted member of the... Read More →
SW

Sacha Wissink

Exec. Director Regulatory Affairs Europe, MSD
Dr. Wissink joined Regulatory Affairs Europe MSD in January 2014 to lead the company’s oncology efforts, including the registration of the PD-1 inhibitor, Keytruda® as well as its developmental activities. Prior to joining Regulatory Affairs Europe, Dr. Wissink was Director, Global... Read More →
avatar for Kirsty Wydenbach

Kirsty Wydenbach

Deputy Unit Manager, Clinical Trials Unit, MHRA
Joined MHRA in 2009, as the Senior Medical Assessor and Deputy Unit Manager in the Clinical Trials Unit. Involved in the UK regulation of clinical trials across all therapy areas and all phases of development, including trials for chemical and biological products, Advanced Therapy... Read More →


Wednesday February 6, 2019 16:45 - 18:00
F1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Clinical Development
  • Tags Session

16:45

#S0504: Dialog with Patients - Moving Forward with Digital Information
Component Type: Session

Patients are no longer satisfied with static pdfs of patient leaflets on the web - they want information about their medicines that takes advantage of all the options available with web based information. How are we going to rise to that challenge? Evidence from research, industry and patients about the goals will be presented and how we might achieve them. The session will be interactive, and include plenty of time for a discussion with the panel at the end.

Chair

D.K.Theo Raynor, PhD, MPharm

Speaker

What are the Imperitives for Industry?
Aimad Torqui, MSc

Reflections from a Patient Expert
Trishna Bharadia



Speakers
avatar for Trishna Bharadia

Trishna Bharadia

Patient Advocate, International Speaker, Writer, Advisor and Content Reviewer, -
Multiple award-winning patient advocate Trishna Bharadia raises awareness & improves support for people affected by chronic illness. She aims to put the patient voice into the entire healthcare journey. She collaborates with organisations globally, including from industry, the third... Read More →
KB

Kirstin Blackwell

Senior Manager, Luto Research Ltd
Kirstin Blackwell has been with Luto Research for the best part of a decade and during this time she has collaborated with stakeholders across the EU and US to develop and test a range of healthcare communication materials. With extensive involvement in moderating and observing User... Read More →
DR

D.K.Theo Raynor

Professor of Pharmacy Practice, University of Leeds
A hospital pharmacist before becoming inaugural Professor of Pharmacy at Leeds, Theo has 35 years of research improving patient information and ‘user testing’ the information with lay people. This led to forming the spin-out company Luto Research , a leading provider of user testing... Read More →
AT

Aimad Torqui

Director Global Regulatory Policy, MSD
Aimad Torqui is Director of Global Regulatory Policy at MSD. Previous employment includes Medicines Evaluation Board and Novartis Vaccines. He has worked with governments, regulators, trade bodies and other external stakeholders to shape robust science-based regulatory policy.


Wednesday February 6, 2019 16:45 - 18:00
G2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Medical Affairs
  • Tags Session

16:45

#S0604: Outcomes Measurement: The Key to Value-Based Healthcare
Component Type: Session

The concept of Value Based Health Care (VBHC) is becoming a leading principle in hospitals to guide quality of care. In order to establish VHBC quality of care is measured with patient relevant outcomes using ICHOM (International Consortium for Health Outcomes Measurement) criteria. During this session we will introduce VBHC and the ICHOM outcomes but also discuss an example of breast cancer care for which VBHC and ICHOM have been used. Subsequently, different stakeholders such as industry, HTA, regulators and patients discuss to which extent VBHC and ICHOM could be relevant for the development of new drugs, for instance in breast cancer, and their value assessment by regulators and HTA.

Chair

Wim Goettsch, PhD, MSc

Speaker

Panelist
Annemarie Haverhals, MSc

Panelist
Adam Heathfield, PhD

Panelist
Niklas Hedberg, MPharm

Panel Discussion
Hubert G. M. Leufkens, PharmD



Speakers
avatar for Wim Goettsch

Wim Goettsch

Special Advisor HTA, Dutch National Health Care Institute (ZIN)
Wim Goettsch, PhD is currently Special Advisor HTA at the Dutch National Health Care Institute He was the Director of the EUnetHTA JA3 (2016-2020) Directorate between June 2016 and March 2018. He also has a position as an affiliate associate professor at Utrecht University (NL). He... Read More →
avatar for Annemarie Haverhals

Annemarie Haverhals

Independent Consultant On VBHC
Annemarie Haverhals is an independent healthcare consultant stimulating the implementation of value based healthcare delivery as a way to improve value for patients. Previously she was responsible for the design and implementation of Santeon’s Value Based Healthcare Program (Santeon... Read More →
avatar for Adam Heathfield

Adam Heathfield

Senior Director, Patient and Health Impact, Pfizer
Adam has worked for Pfizer for over 10 years. His current role is Senior Director in Pfizer’s Patient and Health Impact division. Previously, Adam has worked in Pfizer’s international policy division and led Pfizer’s work on science policy in Europe for several years. Adam initially... Read More →
avatar for Niklas Hedberg

Niklas Hedberg

Chair EUnetHTA Executive Board, Chief Pharmacist, Dental and Pharmaceutical Benefits Agency, TLV
Niklas Hedberg, MSc, is Chief Pharmacist for the Dental and Pharmaceuticals Benefits Agency (TLV) in Sweden. He is also Chair of the EUnetHTA Executive Board, TLV’s lead partner in EUnetHTA, and has led EUnetHTA WP3 – Evaluation since 2016. Mr. Hedberg has broad experience in... Read More →
avatar for Hubert Leufkens

Hubert Leufkens

Professor, Pharmaceutical Policy and Regulatory Science, Utrecht University
Hubert (Bert) G. Leufkens is professor of Pharmaceutical Policy and Regulatory Science at Utrecht University. He is research and policy-wise active at several (inter)national platforms on innovation, drug safety, pharmaceutical policy and regulatory science (e.g. past-member EMA Pharmacovigilance... Read More →


Wednesday February 6, 2019 16:45 - 18:00
K1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Value and Access
  • Tags Session

16:45

#S0704: Digital Innovation is Revolutionising All Aspects of Trial Execution: Opportunities and Requirements
Component Type: Session

Digital innovation is a key enabler in the drive to modernise clinical trials and make them faster, better and different. Technology promises to bring efficiency to our processes, insights for planning, richer information on interventions being studied, and new paradigms to simplify trial participation. How do we leverage these new approaches to gain efficiencies, increase the quality of clinical research and remain in compliance with current regulatory requirements and thinking?

Chair

Bill Byrom, PhD

Speaker

Virtual Trials
Scott Askin

TransCelerate's Common Protocol Template: Overview and Implementation Case Studies
Mitzi Allred, PhD

Endpoints Using Wearables: How Do I Know Data Will Be Accepted?
Bill Byrom, PhD



Speakers
avatar for Mitzi Allred

Mitzi Allred

Director Clinical Operations [Head, Clinical Content Standards], MSD
Mitzi Allred is a Director at MSD where her focus is on Structured Content Management and Regulatory Writing. She has over 20 years of experience in the biopharmaceutical industry in Regulatory & Clinical Operations. Mitzi uses process improvement through information design and structured... Read More →
SA

Scott Askin

Digital Solutions Director, Novartis
Scott Askin, a Digital Solutions Director with Novartis, plays a leading role in many of the company’s digital projects such as eSource (electronic Source), electronic Informed Consent (eICF/eConsent) and Decentralized Clinical Trials. He has ~20 years of industry experience, from... Read More →
avatar for Bill Byrom

Bill Byrom

Vice President, Product Strategy and Innovation, CRF Health
Bill leads product strategy and innovation at CRF Health. He has worked in the Pharmaceutical industry for over 25 years and is the author of over 70 publications and an industry textbook on ePRO. His recent scientific work includes the use of wearable technology and BYOD eCOA in... Read More →


Wednesday February 6, 2019 16:45 - 18:00
F2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Data and Data Standards
  • Tags Session

16:45

#S0804: Update on PMDA’s Activities
Component Type: Session

In this session, PMDA will share the latest details regarding its policies and initiatives and other related strategic directives. The goal of the session will be to keep participants informed of the agency’s handling of the most critical issues facing Japanese and global stakeholders. The session will also include time for Q&A.

Chair

Nobumasa Nakashima, PhD

Speaker

PMDA’s Regulatory Science and Innovation
Tatsuya Kondo, MD, PhD

Regulatory Updates – Facilitating Early Patient Access
Kenichi Mikami, MPharm

Real World Data Utilisation: PMDA’s Approach to Pharmacovigilance
Daisaku Sato, PhD, MPharm



Speakers
avatar for Tatsuya Kondo

Tatsuya Kondo

Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Tatsuya Kondo is Chief Executive of PMDA since 2008. He spent most of his career as a neurosurgeon after his graduation from the University of Tokyo in 1968. He has various experiences including a hospital doctor, a fellowship in Max-Planck Institute for brain tumor research... Read More →
KM

Kenichi Mikami

Office Director, Office of Review Management, Pharmaceuticals and Medical Devices Agency (PMDA)
Mr. Mikami has taken his position as Office Director of Office of Review Management, Pharmaceuticals and Medical Devices Agency (PMDA), Japan since July 2018. After he earned his master degree at Graduate School of Pharmaceutical Sciences, Tohoku University, Mr. Mikami joined Ministry... Read More →
avatar for Nobumasa Nakashima

Nobumasa Nakashima

Senior Director for International Programs, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Nakashima joined Pharmaceutical and Food Safety Bureau of Ministry of Health, Labor, and Welfare (MHLW) in 1992. He spent his career in the international field such as at WHO and OECD, not only in the domestic field. He worked as International Planning Director since September... Read More →
DS

Daisaku Sato

Chief Management Officer & Associate Centre Director for Advanced Evaluation, Pharmaceuticals and Medical Devices Agency (PMDA)
Daisaku Sato is Chief Management Officer & Associate Centre Director for Regulatory Science, Pharmaceuticals and Medical Devices Agency (PMDA). From June 2016 to July 2018, he was Director, Pharmaceutical Safety Division, Pharmaceutical Safety and Environmental Health Bureau, the... Read More →


Wednesday February 6, 2019 16:45 - 18:00
K2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Regulatory Science
  • Tags Session

16:45

#S0304: Decision Science, Communication and Pharma Comparing Older People to Younger Ones with Regard to Making Decisions about Taking Pharmaceuticals
Component Type: Session

Until recently, interest in how older adults make decisions with regard to the taking of pharmaceuticals has surprisingly been an under-researched area despite the obvious needs. What research does show is that older individuals display poorer decision-making competence skills than younger individuals. This in turn leads to older people having more difficulties with numeric processing and with “wisdom” or “experience” becoming more important than scientific findings. The panel will examine a series of topics, including:
a) If the elderly can be better supported to become more involved and proactive
b) What should be in place to better manage their pill burden
c) Why we don’t have better data on treatment effectiveness in the elderly and finally
d) Should there be a geriatric legislation, similar to the paediatric

Chair
Ragnar Lofstedt

Panelist

Dominic Balog-Way

Panelist

David Haerry

Panelist

Fariba Mirzaei

Panelist
Jasminka Tadin


Speakers
DB

Dominic Balog-Way

Research Associate, King's College London
avatar for David Haerry

David Haerry

Member, European AIDS Treatment Group
David has been involved with health care professionals’ education projects since 2007 and, in 2015, became Secretary General for the Swiss Academic Foundation on Education in Infectious Diseases (SAFE-ID). He has been Work-Package Co-leader and a member of the Executive Committee... Read More →
RL

Ragnar Lofstedt

Professor of Risk Management, Kings College London
JT

Jasminka Tadin

Spokesperson, Croatian Agency for Medicinal Products and Medical Devices


Wednesday February 6, 2019 16:45 - 18:00
TBD Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

16:45

#S0904: Fighting Falsified Medicines in Europe –Supply Chain Digitalisation for the Benefit of Patients: Are You Ready?
Component Type: Session

The FMD comes into force on 9th February 2019. This session will discuss a few of the practical issues which may come up during the go-live phase, including the current state of play, the use of the data by the supervising authority, the enforcement of the rules and the handling of alerts in the system.

Chair

Andreas Walter

Speaker

Legislative Framework
Agnes Mathieu-Mendes, RPh

State of the EMVS
Andreas Walter

Case Study
Belen Escribano Romero, PharmD, MPA

Case Study
Philippe De Buck, MPharm



Speakers
avatar for Andreas Walter

Andreas Walter

Director General, European Medicines Verification Organisation
After studying Administration Sciences at the U of Konstanz (DE) Andreas M. Walter joined EFPIA in 1993 as Executive for Administration and Finance. From 2011, he was Project Director tasked with ensuring the compliance of EFPIA members with the safety requirements of the Falsified... Read More →
avatar for Philippe De Buck

Philippe De Buck

Head of Authorisations, FAGG-AFMPS
Philippe serves currently as Head of the Division Authorisations, overseeing the issuing of MIA, WDA, narcotics, etc. licences. Before this he trained as a pharmacist and started his professional career in pharmacy software development, followed by a switch to inspector for the Pharmaceutical... Read More →
avatar for Agnes Mathieu-Mendes

Agnes Mathieu-Mendes

Deputy Head of Unit, European Commission
Agnès Mathieu-Mendes is deputy Head of the unit dealing with the quality, safety and innovation of medicinal products in the Directorate General on Health and food safety in the European Commission. Her responsibilities include the implementation of the falsified medicines Directive... Read More →
avatar for Belen Escribano Romero

Belen Escribano Romero

Head of Department, Pharmaceutical Inspection and Enforcement, AEMPS
Belén Escribano PhD, Head of Department, AEMPS PhD in Pharmacy from Madrid University Complutense and Hospital Pharmacy Specialist. Since 2007 is the Head of the Pharmaceutical Inspection and Enforcement Department of the Spanish Agency for Medicinal Products and Medical Devices... Read More →


Wednesday February 6, 2019 16:45 - 18:00
E1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

16:45

#LOT03: Regulatory Affairs: Career Opportunities and Field Development
Component Type: Session

Regulatory Affairs, an often unknown but a diverse and dynamic discipline which is a critical part of our healthcare system. Regulatory Affairs professionals are at the forefront of the development of new medicinal therapies, diagnostics and technologies as they support or manage key steps in product development, ranging from early research to post-marketing activities.

Chair

Cécile Bertin, PharmD

Speaker

Introduction
Cécile Bertin, PharmD

A Regulator's Perspective - Main Activities
René Anour, DVM

Industry View
Marloes van Bruggen, MS



Speakers
RA

René Anour

Senior Clinical Expert, AGES
René Anour started his doctoral studies at the Institute of Pathophysiology at the University of Veterinary Medicine, Vienna where his research was focused on bone and mineral homeostasis. After graduation he was invited as a visiting scientist to Harvard School of Dental Medicine... Read More →
avatar for Cécile Bertin

Cécile Bertin

Associate Regulatory Program Manager, F. Hoffmann La Roche LTD.
Cécile holds a Pharm.D and a Master’s in International Drug Development and Registration. She joined Roche headquarters in Basel in 2015, first as a trainee and then as a post graduate. She currently works as an Associate Regulatory Program Manager in the Oncology Department. Her... Read More →
avatar for Marloes van Bruggen

Marloes van Bruggen

Regional Regulatory Policy Lead, F.Hoffmann-La Roche Ltd.
Marloes has a MSc in Drug Innovation with focus on regulatory affairs. She started at Roche as an intern in 2010 and has since progressed to a Regulatory Intelligence Manager and currently works as Regional Regulatory Policy Lead. She focuses on acquiring and maintaining an overview... Read More →


Wednesday February 6, 2019 16:45 - 18:00
0.96-0.97 (Level 0) Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

17:15

#CH304: New Changes to the National Drug Code in the U.S.
Component Type: Session
Level: Intermediate



Chair

Leyla Rahjou-Esfandiary, PharmD


Speakers
LR

Leyla Rahjou-Esfandiary

Lead CSO, Office of Compliance, CDER, FDA
Leyla Rahjou-Esfandiary, Pharm D, is a Lead Consumer Safety Officer with FDA's CDER, Office of Compliance. She joined the Drug Registration and Listing Staff in 2008 and has been a big part of CDER's implementation of electronic Drug Registration and Listing System (eDRLS), developing... Read More →


Wednesday February 6, 2019 17:15 - 17:45
Content Hub 3 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

18:00

#NW02: Networking Reception in the Exhibition Hall
Component Type: Social Event




Wednesday February 6, 2019 18:00 - 19:00
Exhibition Hall Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
 
Thursday, February 7
 

08:30

#KN3: Health Systems: Doomed to Fail or About Be Saved by a Copernican Shift?
Component Type: Session



Speaker

Health Systems: Doomed to Fail or About Be Saved by a Copernican Shift?
Kristel Van der Elst



Speakers
avatar for Kristel Van der Elst

Kristel Van der Elst

CEO, The Global Foresight Group
Kristel Van der Elst has 17 years of experience in forward-looking strategy and policy advisory roles. She works with senior executives and policy makers including heads of state, ministers, heads of international organisations and think tanks, and CEOs providing the insights, resources... Read More →


Thursday February 7, 2019 08:30 - 09:00
E1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

09:15

#CH104: Patient-reported, Patient-relevant, Patient-centred outcomes: definitions, roles and importance for health technology assessment
Component Type: Session
Level: Intermediate



Learning Objectives

Provide a clear definition of Patient-reported, patient-relevant and patient-centered outcomes, their roles as well as role of patients’ involvement in regulatory and HTA process in Europe

Chair

Mira Pavlovic, DrMed, MS


Thursday February 7, 2019 09:15 - 09:45
Content Hub 1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

09:15

#CH203: Innovation in Pharmacovigilance
Component Type: Session
Level: Intermediate



Chair

Christian Mueller, DrSc


Speakers
avatar for Christian Mueller

Christian Mueller

Global Head of Safety Analytics and Reporting, F. Hoffmann-La Roche AG
PhD in Immuno-biochemistry at the University of Lausanne in Switzerland (1995). Master program in Applied Statistics (Neuchâtel, 1997) Biometrics in Pharmaceutical Industry: Novartis (1997 – 2017) then Roche (2017 – 2016). Project statistician in Novartis, a 6-month rotation... Read More →


Thursday February 7, 2019 09:15 - 09:45
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

09:15

#CH305: Data’s Revenge
Component Type: Session
Level: Basic



Chair

Olaf Schoepke, PhD


Speakers
avatar for Olaf Schoepke

Olaf Schoepke

VP Regulatory Solutions, Samarind, Instem
Dr. Olaf Schoepke studied Computing Sciences in Germany and holds a PhD in Computer Architecture from Bath University (UK). He is now the Director of Strategic Development at Samarind Ltd., having worked for PricewaterhouseCoopers, advising pharmaceutical companies worldwide on document... Read More →
avatar for Olaf Schoepke

Olaf Schoepke

VP Regulatory Solutions, Samarind, Instem
Dr. Olaf Schoepke studied Computing Sciences in Germany and holds a PhD in Computer Architecture from Bath University (UK). He is now the Director of Strategic Development at Samarind Ltd., having worked for PricewaterhouseCoopers, advising pharmaceutical companies worldwide on document... Read More →


Thursday February 7, 2019 09:15 - 09:45
Content Hub 3 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

09:15

#S0105: Opportunities in Regulatory System Optimisation - How to Maximise the Benefit?
Component Type: Session

An efficient, well-functioning EU regulatory system is critical for timely access to medicines. Due to increasing pressure on authorities and industry’s resources, the optimisation of regulatory processes can bring a significant benefit for all stakeholders. The session will focus on possible solutions which can be put in place to improve the efficiency of the regulatory operations.

Chair

Beata Stepniewska, MPharm

Speaker

Working Smarter, Not Harder - Why Do We Need Regulatory Optimisation?
Beata Stepniewska, MPharm

Regulatory Optimisation as an Important HMA Priority 
Hugo Hurts

Realising the Benefits of Regulatory Optimisation 
Sarah Montagne



Speakers
avatar for Hugo Hurts

Hugo Hurts

Chair HMA Task Force; Executive Director, Medicines Evaluation Board (MEB)
BS

Beata Stepniewska

Deputy Director , Head of Regulatory Affairs, Medicines for Europe
B.Stepniewska after an academic career at the Fac. of Pharmacy as Head of the Dep. of Pharm. Law and Pharmacoeconomics, joined the industry as Head of the Regulatory Dep for PLIVA Krakow. She has now been with the European Generic medicines Association (now Medicines for Europe) since... Read More →
avatar for Sarah Montagne

Sarah Montagne

Bayer PLC
Sarah Montagne holds a Bachelor of Science 2(1) Degree in Toxicology and Law. In her current position she is responsible for addressing EU regulatory policy topics impacting on the Company and taking operational responsibility for the UK regulatory team based in Reading, UK. Using... Read More →


Thursday February 7, 2019 09:15 - 10:15
E1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Regulatory Science
  • Tags Session

09:15

#S0205: Orphan and Paediatric Medicines – Future Direction and Regulatory Landscape
Component Type: Session

The EU orphan and paediatric regimes aim at addressing specific patient and public health needs. They form part of the scope of the current incentives review. What are the dynamics of the systems, what lessons can be learnt, what way to go forward?

Chair

Peter W.L. Bogaert, MA

Speaker

The Current Legal Interpretation of the EU Orphan Medicines Regime by the EU Courts
Peter W.L. Bogaert, MA

Pediatric Orphan Medicines Development in Rare Diseases
Dinah Duarte, MSc

Patient Perspective
Dimitrios Athanasiou, MBA



Speakers
avatar for Dimitrios Athanasiou

Dimitrios Athanasiou

Patient Advocate, WORLD DUCHENNE ORGANIZATION (WDO) , MDA HELLAS
Dimitrios Athanasiou is a PDCO member representing EURORDIS. He holds a BA and an MBA in Financial Management He attended Eurordis Summer School and European Patient Academy (EUPATI) acquiring basic biotech and regulatory knowledge. As a full time patient advocate in DMD, he is a... Read More →
avatar for Peter Bogaert

Peter Bogaert

Partner, Covington & Burling LLP
A managing partner of the Brussels office of Covington & Burling, with a broad European life sciences practice. He has detailed regulatory expertise under EU and national laws, handles legislative and other policy assignments and provides strategic advice. Also represents life sciences... Read More →
avatar for Dinah Duarte

Dinah Duarte

Scientific Evaluation Unit, Directorate of Medicinal Products, INFARMED
Dr. Dinah Duarte is a senior assessor at the Scientific Evaluation Unit at the Directorate of Medicinal Products, in the Portuguese regulatory authority for medicines and health products (INFARMED). She is an expert member at the European Medicines Agency (EMA); the current Committee... Read More →


Thursday February 7, 2019 09:15 - 10:15
G1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Translational Medicine
  • Tags Session

09:15

#S0905: Converging Global Life Science Regulation – Where Are We Heading in 2025?
Component Type: Session

The session will set out a vision for a globalised regulatory framework and provide opportunity for regulators and industry to discuss the current and future state of convergence for the benefit of patients’ access. Faster adoption of new technologies, common global standards & requirements, increased collaboration among regulators and rapid adoption of new technologies can accelerate the regulatory licensing process, simplify compliance and facilitate the regulatory surveillance of marketed medicinal products. What can we do to make this happen?

Chair

Angelika Joos, MPharm

Speaker

The Future of Regulation: How to Thrive in the Converging Regulatory Environment
Sebastian Payne

EFPIA Perspective on Global Regulatory Convergence
Thomas Kühler, PhD, MSc

Regulators Setting Global Standards
Lenita Lindström-Gommers, LLM

WHO Supporting Regulators for Capacity Building and Global Collaboration
Mike Ward

IFPMA Views on Regulatory Systems Strengthening and Collaboration
Judith Catherine Macdonald



Speakers
avatar for Angelika Joos

Angelika Joos

Executive Director, Global Regulatory Policy, MSD (Europe) Inc.
Angelika Joos, MPharm, is responsible for Regulatory Policy issues within MSD's Global Regulatory Affairs and Clinical Safety department. This role includes identifying regulatory policy priorities that align with MSD’s business priorities, leading cross-functional networks to define... Read More →
avatar for Thomas Kühler

Thomas Kühler

Head GRSP EU/AMESA, Sanofi R&D
avatar for Lenita Lindström-Gommers

Lenita Lindström-Gommers

ICH Assembly Chair and Senior Expert, European Commission, European Commission
ICH Assembly Chair Senior Policy Officer in DG SANTE/European Commission dealing with international relations in the field of pharmaceuticals
avatar for Judith Macdonald

Judith Macdonald

Head of Global Regulatory Policy & Intelligence, Pfizer
Judith is responsible for global regulatory policy development at Pfizer. She has more than 25 years’ experience in regulatory affairs, where she has been responsible for both small molecule and biological products across the entire development cycle. Judith joined Pfizer in 2007... Read More →
avatar for Sebastian Payne

Sebastian Payne

Associate Director, Deloitte
Sebastian is a Director at Deloitte specialising in Regulatory Advisory within Life Sciences and has over 18 years of experience in Life Sciences and Healthcare (LSHC) consultancy. He leads Deloitte CORE for LS (Centre of Regulatory Excellence for Life Sciences), a global initiative... Read More →
avatar for Mike Ward

Mike Ward

Coordinator, Regulatory Systems Strengthening, EMP, World Health Organization (WHO)
Mike Ward is Coordinator of the Regulatory System Strengthening Team, Department of Essential Medicines and Health Technologies, Health Systems and Innovation Cluster, WHO Headquarters; he joined WHO as the Coordinator, Prequalification Team, in this same Department. He previously... Read More →


Thursday February 7, 2019 09:15 - 10:15
K1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

09:15

#S0305: GVP Module V Risk Management Plan: Lessons Learned One Year after the Revision 2
Component Type: Session

This session will provide an overview on Risk Management Plan preparation nearly two year after of the implementation of the revision 2 of module V and the updated RMP template. The lessons learned from that change and challenges will be presented and discussed by a panel of experts from industry and regulatory authorities.

Co-Chairs

Francoise Dumas-Sillan
Sabine Straus, MD, PhD, MSc

Speaker

Result of the EFPIA Survey on the RMP Implementation
Jane Feron

Time to Reflect and Build on Experience: Generics Sector View 
Susana Almeida, PhD



Speakers
avatar for Francoise Dumas-Sillan

Francoise Dumas-Sillan

EU QPPV, Pfizer Italy
Françoise is a medical doctor as background, working in Pharmacovigilance for more than 20 years in big Pharmaceutical companies with different managerial roles (Sanofi, now Pfizer), exposure to international activities and interactions with Health Authorities, and has been in charge... Read More →
avatar for Susana Almeida

Susana Almeida

Clinical Development and Safety Director, Medicines for Europe
Dr. Susana Almeida is Clinical Development and Safety Director at Medicines for Europe. Before joining Medicines for Europe, Susana was the Chair of the Association’s Bioequivalence Working Group for almost 15 years. She has worked in clinical development in Europe and in North... Read More →
avatar for Sabine Straus

Sabine Straus

PRAC Chair, Staff Member, Medicines Evaluation Board (MEB)
Dr. Sabine Straus has been with the Medicines Evaluation Board (MEB) in the Netherlands since 1997, where she started as an Assessor Pharmacovigilance. Prior to working at the MEB she held different positions in the pharmaceutical industry, her last job as Medical Director at Searle... Read More →
avatar for Jane Feron

Jane Feron

Risk Management Director, AstraZeneca UK Ltd
Jane Feron BSc (Hons) has spent most of here working life in the pharmaceutical industry. After working in Clinical Research for nearly 10 years, she joined the PV department at AstraZeneca. She worked in safety surveillance before becoming the process owner for Risk Management and... Read More →


Thursday February 7, 2019 09:15 - 10:15
E2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Pharmacovigilance
  • Tags Session

09:15

#S0405: Reducing Cost and Improving Quality of Clinical Trials
Component Type: Session

Discover three questions to ask before you innovate to reduce cost and improve quality of clinical trials from lessons learned.

Chair

Clara Heering, MS, MSc

Speaker

Evolution of RBM - Risk-Based Quality Management
Artem Andrianov, PhD, MBA

Implementing a Scalable Risk-Based Monitoring Strategy
Richard Davies

How to drive forward clinical development between Japan and EU?
Hideyuki Kondo, MBA

An Integrated Artificial Intelligence Platform for Clinical Study Management
Manfred Koehler, DrSc



Speakers
avatar for Artem Andrianov

Artem Andrianov

CEO, Cyntegrity Germany GmbH
Artem Andrianov graduated with degrees in software engineering, and MBA. After graduation, he defended a PhD with the focus on mathematical modeling. Artem started his career at CareFusion, and after three years shifted to the position of Development Manager with a focus on Data Quality... Read More →
avatar for Richard Davies

Richard Davies

Vice President, Solution Expert, CluePoints
Richard Davies joined CluePoints in September 2018 and is based in the UK. As VP, Solution Expert his role is to support organizations’ adopting CluePoints solutions from a technical, functional and business process perspective, particularly as they execute their vendor selection... Read More →
CH

Clara Heering

Enterprise JJCO lead for Capacity & Alliance Management, Johnson & Johnson
Clara Heering is lead for Capacity and Alliance management at Johnson & Johnson Clinical Operations. Clara began her career as Research Fellow at Harvard Medical School, then joined Pfizer in Clinical Research & Development, where she served in roles of increasing responsibility for... Read More →
MK

Manfred Koehler

CEO, Koehler eClinical GmbH
CEO and Founder KOEHLER eClinical GmbH in Freiburg, Germany.
avatar for Hideyuki Kondo

Hideyuki Kondo

Deputy Director, Office of International Program, Pharmaceuticals and Medical Devices Agency (PMDA)
Hideyuki Kondo experienced, for more than 10 years of carrier in Ministry of Health, Labour and Welfare, Japan, several positions in the field of pharmaceutical and medical device regulations, including those related to pre-market review policies, GMP/QMS inspections, post-market... Read More →


Thursday February 7, 2019 09:15 - 10:15
F1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Clinical Development
  • Tags Session

09:15

#S0505: How to Extend MSL Expertise to Patient Engagement Activities
Component Type: Session

This session will focus on : Perspectives from Patient Groups - Knowing What They Want; Considerations for MSL Engagement with Patients/Patient Groups in Rare Disease Areas; Centrally Moderated Support for Patient Directed MSL Engagement

Chair

Rebecca A. Vermeulen, RPh

Speaker

Perspectives from Patient Groups - Knowing What They Want
Pisana Maria Ferrari

Considerations for MSL Engagement with Patients/Patient Groups in Rare Disease Areas
Lori Mouser, PharmD

Centrally Moderated Support for Patient Directed MSL Engagement
Anja Schaefer, DrSc, MSc



Speakers
avatar for Lori Mouser

Lori Mouser

Global Head, Medical Science Liaisons, F. Hoffmann-La Roche Ltd.
Lori Mouser brings over 15 years of experience in leading Medical Science Liaison teams to her role as Global Head of MSLs for Roche Product Development-Medical Affairs. Lori thrives on collaborating across teams to find clever approaches to challenging situations.  She strives... Read More →
avatar for Anja Schaefer

Anja Schaefer

Chief Executive Officer, TaRes GmbH
Anja Schaefer has since 2014 been CEO of a strategy consultancy company TaRes GmbH, Germany. She has more than 25 years experience in the health care industry including international leadership roles for pharmaceutical and medical device companies in various medical affairs functions... Read More →
avatar for Rebecca Vermeulen

Rebecca Vermeulen

Head, Customer Strategy Global Medical Affairs, Hoffmann-La Roche Ltd.
Rebecca Vermeulen, RPh, brings a variety of experiences to her role as Customer Strategy and Patient Partnership for Global Medical Affairs at Roche. She has served in numerous functions including Medical Affairs, Clinical Research, Sales, Medical Communications, Medical Science Liaisons... Read More →
PF

Pisana Ferrari

Vice President, PHA Europe, European Pulmonary Hypertension Assoc.


Thursday February 7, 2019 09:15 - 10:15
G2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Medical Affairs
  • Tags Session

09:15

#S0705: Can We Improve Patient Experience with Digitisation – Part 1: Patient Information
Component Type: Session

Patients expect to take greater accountability for their health, are researching symptoms and taking greater control of the treatment of their disease. Timely access to reliable information in a format that is suitable for patients in the 21st century will transform communication with patients in the healthcare setting.

Chair

Valdo Arnera, DrMed, MD

Speaker

How eConsent will Support Study Oversight and Future Enhancement of Informed Consent
Mika Lindroos, MSc

Towards an Electronic Patient Information Leaflet – Industry Experience with the Belgian Pilot
Koen Nauwelaerts, PharmD, PhD, MBA



Speakers
avatar for Valdo Arnera

Valdo Arnera

General Manager, Europe, ERT
An MD by training, Valdo has 30+ years of experience in the pharma industry. After having practiced medicine, he started in the industry as a clinical pharmacologist at Ciba-Geigy. He then founded the 1st European Central Clinical Lab for clinical trials, SciCor (now Covance Central... Read More →
avatar for Mika Lindroos

Mika Lindroos

Director, Product Management, eConsent, CRF Bracket
Mika Lindroos is the Director of Product Management and an eConsent expert at CRF Bracket, and he says he is most at home where technology meets humanity. With over 24 years of experience in software product management in the global environment, Mika’s breadth of experience spans... Read More →
KN

Koen Nauwelaerts

Head Regulatory Affairs and Quality Belgium Luxemburg, Bayer
Koen Nauwelaerts studies pharmaceutical sciences at Leuven University in Belgium and obtained a PhD at the same university. Before joining Bayer he worked in Quality and regulatory affairs functions in the pharmaceutical industry.


Thursday February 7, 2019 09:15 - 10:15
F2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Data and Data Standards
  • Tags Session

09:15

#S0805: China - Update on the Regulatory Environment
Component Type: Session

• Latest Changes in NMPA • Update on the (Clinical) Development Environment /Regulations/Approvals in China • Update on the GCP/GMP Environment in China and its Changes

Chair

Joseph C. Scheeren, PharmD

Speaker

The Latest Progress of the Drug Regulatory Environment in China
Jianqing Chang, DrMed

China Speed: An Overview of Fast Evolving Biopharma Innovation Ecosystem in China
Walter Beck, DVM

Panelist
Lingshi Tan, PhD



Speakers
WB

Walter Beck

VP RD CO Head of Business Excellence & Innovation, Bayer AG
More than 30 years work experience in Clinical Development at Schering and Bayer. Different roles in Clinical Development and Clinical Operations including Global Data Management Head. Since 2014 Head of Business Excellence & Innovation in Clinical Operations in Bayer Pharmaceuticals... Read More →
avatar for Joseph Scheeren

Joseph Scheeren

Chair of the Board of Directors, DIA
Joseph Scheeren, Pharm.D. is Dutch and studied pharmacy at the University of Leiden. He has a long global career in the pharmaceutical industry in development and in Regulatory Affairs (RA). He has joined Bayer in 2004 as SVP, Head of RA and Development responsible for the US. He... Read More →
avatar for Lingshi Tan

Lingshi Tan

Chief Exceutive Officer, Dmed
Lingshi Tan, PhD, is Chairman and Chief Executive Officer of dMed Co. Ltd., a China-based contract research organization. Prior to founding dMed, Dr. Tan was Pfizer’s Vice President of Worldwide Development Operations, and Chairman and General Manager of Pfizer (China) Research... Read More →


Thursday February 7, 2019 09:15 - 10:15
K2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

09:15

#S0605: How to Facilitate Access to Advanced Therapy Medicinal Products in Europe
Component Type: Session

This session will focus on current experiences and challenges surrounding the market access of advanced therapy medicinal products. (ATMPs). The session will also highlight opportunities to secure access for patients to these innovative therapies, in particular for ATMPs addressing diseases with high unmet medical needs.

Chair

Maria Pascual, PharmD

Speaker

Can We Improve Access to ATMPs? The Results of ARM’s Multi-Stakeholder Study
Paolo Morgese, MSc

Practical Challenges for Access of ATMPs in Europe – An Industry Perspective
Etienne Jousseaume

Challenges in the Development of ATMPs in Europe – A Regulator Perspective
Ilona G. Reischl, PhD, MPharm



Speakers
EJ

Etienne Jousseaume

Head Market Access Cell and Gene Europe, Novartis
avatar for Paolo Morgese

Paolo Morgese

Director, EU Market Access and Member Relations, Alliance for Regenerative Medicine (ARM)
Paolo is a healthcare investment and market access professional with more than 15 years of experience in both assessing and supporting access to innovative healthcare technologies. Paolo’s interests and expertise are centered around healthcare technology value assessment and maximization... Read More →
MP

Maria Pascual

Chair of Advanced Therapies Working Group, EBE-EFPIA
Pharmacy degree from Granada University, PhD in Immunology from Spanish National Research Council, and Master degree in Regulatory Affairs from Barcelona Autonoma University. Worked with peptides and vaccines in autoimmune diseases in LUMC, The Netherlands and Mayo Clinic, US. Specialized... Read More →
MP

Maria Pascual

Chair of Advanced Therapies Working Group, EBE-EFPIA
Pharmacy degree from Granada University, PhD in Immunology from Spanish National Research Council, and Master degree in Regulatory Affairs from Barcelona Autonoma University. Worked with peptides and vaccines in autoimmune diseases in LUMC, The Netherlands and Mayo Clinic, US. Specialized... Read More →
avatar for Ilona Reischl

Ilona Reischl

CAT Vice-Chair, Clinical Trials Assessor, Federal Office for Safety in Health Care(BASG)
Ilona Reischl joined the Austrian Agency in March 2006 and is currently an assessor within the clinical trials unit that is responsible for the evaluation of clinical trials with medicinal products and medical devices as well as GCP inspections. Her background is that of a quality... Read More →


Thursday February 7, 2019 09:15 - 10:15
DIAlogue Space Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Value and Access
  • Tags Session

09:15

#WS01: Automatic Translations Workshop
Component Type: Session

This workshop is for all who manage translations in clinical development and marketing and are interested to hear about and discuss innovative software-driven solutions to speed up any translation.

Chair

Peter Schueler, DrMed, MD

Speaker

Panelist
Alex Farrell

Panelist
Adelina Lear

Panelist
Adam Wozniak, MA



Speakers
AF

Alex Farrell

Regional Director Business Development, TransPerfect
AL

Adelina Lear

Strategic Account Executive, ICON plc
avatar for Adam Wozniak

Adam Wozniak

Director, Program Management, TransPerfect


Thursday February 7, 2019 09:15 - 10:15
0.11-0.12 (Level 0) Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

09:45

#CH105: Pilot Study Exploring Routes of Plain Language Summary Development: In Search of Efficiencies and Optimum Quality
Component Type: Session
Level: Intermediate



Chair

Jennifer Doralt, MSc


Speakers
avatar for Jennifer Doralt

Jennifer Doralt

Lead Medical Writer - Hematology/Oncology, Shire, Now Part of Takeda
Jennifer Doralt is Lead Medical Writer, Clinical Scientific Writing & Clinical Trial Transparency, at Shire, now part of Takeda. She received her Master of Science in International Health Policy from the London School of Economics, and her BA from Northwestern University, in Evanston... Read More →


Thursday February 7, 2019 09:45 - 10:15
Content Hub 1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

09:45

#CH204: Innovative Designs under the New Clinical Trials Regulations
Component Type: Session



Chair

Kirsty Wydenbach, DrMed, MSc


Speakers
avatar for Kirsty Wydenbach

Kirsty Wydenbach

Deputy Unit Manager, Clinical Trials Unit, MHRA
Joined MHRA in 2009, as the Senior Medical Assessor and Deputy Unit Manager in the Clinical Trials Unit. Involved in the UK regulation of clinical trials across all therapy areas and all phases of development, including trials for chemical and biological products, Advanced Therapy... Read More →


Thursday February 7, 2019 09:45 - 10:15
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

09:45

#CH306: Can the Efficacy and Quality of Medical Coding Be Improved by the Use of Artificial Intelligence?
Component Type: Session
Level: Intermediate



Learning Objectives

The participants will be able to: - Describe the basic concepts of medical coding and identify its role in modern clinical research and pharmacovigilance. - Identify advantages and distadvantages of applying Artificial Intelligence in medical coding.

Chair

Malin Gunilla Jakobsson, MPharm, RPh


Speakers
MJ

Malin Jakobsson

Product Strategy Manager, Uppsala Monitoring Centre
Malin Jakobsson is Product Manager at the Uppsala Monitoring Centre. She is a pharmacist and is responsible for the usability of the dictionaries to ensure the products and services meet the user needs. Malin joined the UMC in 2005 and has been involved in drug dictionary developments... Read More →
MJ

Malin Jakobsson

Product Strategy Manager, Uppsala Monitoring Centre
Malin is Product Strategy Manager for WHODrug at Uppsala Monitoring Centre (UMC). She is a pharmacist by training and she has been working with WHODrug in different roles for twelve years, from data validation to production and now she is involved in the strategic development of the... Read More →


Thursday February 7, 2019 09:45 - 10:15
Content Hub 3 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

09:45

#CH407: Coping with a Medicine Mid-Life(Cycle) Crisis: Future Opportunities and Challenges in the Management of Post-Licensing Change
Component Type: Session



Chair

Simon Bennett, MSc


Speakers
SB

Simon Bennett

Director, EU Regulatory Policy, Biogen
As Director of EU Regulatory Policy at Biogen, Simon is responsible for developing and leading Biogen’s European regulatory policy agenda and associated activities. Simon started at Biogen in 2003 in the clinical group before moving into Regulatory Sciences and undertaking increasingly... Read More →


Thursday February 7, 2019 09:45 - 10:15
Content Hub 4 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

10:15

#CHS05: Prudenta: An Electronic Solution for Local Literature Monitoring in Pharmacovigilance
Component Type: Session



Chair

Polina Dombure


Thursday February 7, 2019 10:15 - 10:45
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

10:15

#CB4: Coffee Break in the Exbition Hall
Component Type: Social Event




Thursday February 7, 2019 10:15 - 10:45
Exhibition Hall Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

10:45

#S0106: Regulatory Data Use and Integrity across Stakeholders
Component Type: Session

• Electronic optimisation and recent regulatory updates (e.g. SPOR, IRIS, Telematics strategy) • Ensure data use efficiencies and integrity across stakeholders • Technological advancements in regulatory systems


Co-Chairs
Peter Bachmann
Christa Wirthumer Hoche

Speaker

EMA’s Telematics Strategy/SPOR 
Niels Buch Leander, PhD

The Importance of Data Modelling for Successful Regulatory Affairs Units
Joerg Stueben, DrSc

Regulator Data Exchange Projects within EU
Laurent Desqueper



Speakers
avatar for Peter Bachmann

Peter Bachmann

Deputy-Head, European Union and International Affairs, Federal Institute for Drugs and Medical Devices (BfArM)
Peter Bachmann, PhD, chairs the Coordination Group for Mutual Recognition and Decentralised Procedures – human, and is a Member of the Scientific Coordination Board of the European Medicines Agency. He is also Head of the Unit of European Coordination and Deputy-Head of the Division... Read More →
avatar for Laurent Desqueper

Laurent Desqueper

XEVMPD-IDMP Regional Business Lead, MSD Europe
Laurent Desqueper is Business Lead for XEVMPD/IDMP Digital Transformation in the Regulatory Affairs Operations department at MSD Europe, Brussels, Belgium. After 10 years of IT projects and consultancy, Laurent transitioned to Business Regulatory Pharma topics by working for the European... Read More →
avatar for Niels Leander

Niels Leander

Consulting Director, NNIT
Dr. Niels Buch Leander is a Consulting Director and lead for Regulatory Affairs at NNIT, a global IT service provider to the pharmaceutical industry. Dr. Leander has 10 years of R&D IT project experience with eCTD, eTMF, EDMS, RIMS, xEVMPD and ISO IDMP and hence extensive experience... Read More →
avatar for Joerg Stueben

Joerg Stueben

Head of Regulatory Information Management, Boehringer Ingelheim International Gmbh
Dr Joerg Stueben works as “Head of Regulatory Information Management and Senior Expert” for Boehringer Ingelheim. He oversees all typical activities of a RIM group with a focus on Data Management incl modelling, IDMP/SPOR and Data Quality questions and on exploring AI and new... Read More →
avatar for Christa Wirthumer-Hoche

Christa Wirthumer-Hoche

Chair, EMA Management Board, Head, Austrian Medicines and Medical Devices Agency
Christa Wirthumer-Hoche studied biochemistry TU Vienna, doctoral thesis at Medical Physiology. Starting at the AT Nat. Inst. for Quality Control of Drugs - quality assessment, Head of Regulatory Affairs in the Ministry of Health, Now Head of the Austrian Medicines and Medical Devices... Read More →


Thursday February 7, 2019 10:45 - 11:45
E1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Regulatory Science
  • Tags Session

10:45

#S0206: Regulatory Innovation: Regulatory Science
Component Type: Session

We will discuss the current vibrant environment on science and technology innovation from in academia, industry and society as well as the challenges posed to regulators to enable fast development and access to the innovative medicine(s) solutions.

Chair

Beatriz Silva Lima, PharmD, PhD

Speaker

Regulatory Science in the Next Decade
Beatriz Silva Lima, PharmD, PhD

Multistakeholders’ Interaction is a Key Success Factor for any IMI project – the Experience of the IMI PROactive in COPD Consortium
Solange Corriol-Rohou, DrMed, MD, PhD

Experimental Regulatory Research on Vaccines and CAR T Cells
Klaus Cichutek, PhD

The New Health Paradigm in a Smart World Environment
Marek Tyl, DrSc, MSc

Panelist
Miguel Forte, FACP



Speakers
avatar for Klaus Cichutek

Klaus Cichutek

President, Paul-Ehrlich-Institut
Prof. Dr. Klaus CICHUTEK is the President of the Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, in Germany. PEI is a senior federal agency reporting to the German Federal Ministry of Health and member of the network of the European regulatory authorities united... Read More →
avatar for Solange Corriol-Rohou

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, Europe, Astrazeneca Research & Development
Pulmonologist and immuno-allergologist by training, Solange joined AstraZeneca R&D in 2004. Moving from the French Medicines Agency and hospital to Industry, she has gained strategic experience in drug development. As the chair of the EFPIA Clinical Development Expert Group, she has... Read More →
MF

Miguel Forte

Chief Executive Officer, Miguel Forte
avatar for Beatriz Silva Lima

Beatriz Silva Lima

Professor of Pharmacology; NDA Advisory Board, NDA Advisory Services Limited
i) Coordinates the Group of Pharmacological Sciences of the iMed.ULisboa, ii) for 20 years acted as expert in nonclinical and regulatory science at Infarmed, Portugal and EMEA, UK iii) has been (end July 2012) member of CHMP, CAT and SAWP and Chair of Safety Working Party and EU Co-Deputy... Read More →
MT

Marek Tyl

CEO, Innovation Forum
Marek is a scientist, manager and a technology commercialisation strategist. He completed his PhD at the Department of Biochemistry, University of Cambridge followed by a Post Doc at Imperial College London (chromatin biology). Marek is the Founder and CEO of the Innovation Forum... Read More →


Thursday February 7, 2019 10:45 - 11:45
G1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Translational Medicine
  • Tags Session

10:45

#S0306: Risk Communication: New Directions for the Future
Component Type: Session

Risk communication is an integral component of public health management and need to be continuously updated to meet new and developing demands. When deployed effectively, risk communication is an invaluable tool for engendering trust, protecting organizational value, and helping the public make informed decisions. Conducting risk perception research, addressing the role of trust and having a realistic outlook on the impact of risk communications are crucial considerations in risk communication evolvements for the future. This session aims at discussing implications, insights and key lessons learned from the application of risk communication principles in real-world settings, offering suggestions for risk communication research, policies and strategies.

Chair

Amelia Cupelli, MPharm

Speaker

Benefit-Risk Communication: Lessons from Patients
Dinah Duarte, MSc

Evaluation of the Impact of Risk Communication on Public’s Risk Perceptions Knowledge, Attitudes, and Behaviors including Compliance (Focus groups, Surveys, and other Experiences)
Peter Mol, PhD, RPh

Risk Communication in the European Context, Building on the Best Practice Examples - Lessons from SCOPE Project
Sieta de Vries, PhD



Speakers
avatar for Peter Mol

Peter Mol

Member SAWP, Principal Clinical Assessor, Dutch Medicines Evaluation Board & University Medical Center Groningen
Peter Mol is a principal assessor at the Dutch Medicines Evaluation Board and a member (vice chair) of EMA’s Scientific Advice Working Party. He is chair of the EMA Cross-Committee Task force on Registries. He is also an assistant professor at the University Medical Center Groningen... Read More →
avatar for Dinah Duarte

Dinah Duarte

Scientific Evaluation Unit, Directorate of Medicinal Products, INFARMED
Dr. Dinah Duarte is a senior assessor at the Scientific Evaluation Unit at the Directorate of Medicinal Products, in the Portuguese regulatory authority for medicines and health products (INFARMED). She is an expert member at the European Medicines Agency (EMA); the current Committee... Read More →
avatar for Amelia Cupelli

Amelia Cupelli

Senior Pharmacovigilance Assessor, PRAC member, AIFA
Amelia Cupelli has been in force at the Italian Medicines Agency (AIFA) since 2011 as pharmacovigilance assessor. She is a pharmacologist. Prior to joining the AIFA, she held positions for 15 years in pharmaceutical industry and as hospital pharmacist. She has participated in the... Read More →
SD

Sieta de Vries

Post-doctoral researcher, University Medical Center Groningen
Sieta de Vries obtained her master’s degree in Social Psychology in 2010 after which she conducted her PhD-project at the University Medical Center Groningen (UMCG) in the Netherlands. She graduated in 2015 on the PhD-project with the title ‘Patient perspectives in the benefit-risk... Read More →


Thursday February 7, 2019 10:45 - 11:45
E2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Pharmacovigilance
  • Tags Session

10:45

#S0406: Will Patient Involvement Improve Clinical Research?
Component Type: Session



Chair

Jan Geissler, MBA

Speaker

The EUPATI Patient Qualification Programme
Jan Geissler, MBA

Patient Preferences for Medical Decision Making - A Portfolio of Case Studies Using Patient Preference Methods in Different Patient Populations
Ardine De Wit



Speakers
avatar for Matt Cooper

Matt Cooper

Business Development and Marketing Director, NIHR Clinical Research Network
Matt has been Business Development & Marketing Director at the Clinical Research Network Coordinating Centre since 2014, having been part of the Network structure for a decade. In a previous roles he was a member of the leadership team of the National Cancer Research Network and before... Read More →
avatar for Jan Geissler

Jan Geissler

CEO, Patvocates
Founder and Managing Director of Patvocates. Former Director of the European Patients' Academy (EUPATI). Cancer survivor and co-founder of the CML Advocates Network, the Leukemia Patient Advocates Foundation, LeukaNET, Leukämie-Online and the European Cancer Patient Coalition.
avatar for Ardine De Wit

Ardine De Wit

Associate Professor of HTA, University Medical Center Utrecht


Thursday February 7, 2019 10:45 - 11:45
F1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Clinical Development
  • Tags Session

10:45

#S0606: Precision Medicine into Action: The Case of a Histology Independent Label - What Implications for Value Assessment?
Component Type: Session

A histology-independent label (encompassing all tumours with a common biomarker, regardless of tumour type) will cover an extremely heterogeneous population with varied comparators and prognoses, and likely be based on evidence from non comparative basket trials, with little or no data on survival outcomes. Representatives from health technology assessment (HTA) bodies, industry and patient organisations will discuss the challenges this poses for the value assessment of these drugs, and explore possible solutions to facilitate timely access to potentially innovative treatments for patients with no alternative options.

Chair

Sophie Cooper

Speaker

Panel Discussion
Linda Landells, PhD

Panel Discussion
Iain Leslie

Panel Discussion
Bettina Ryll

Panel Discussion
Anja Schiel, PhD

Panel Discussion
Stephen Palmer



Speakers
avatar for Sophie Cooper

Sophie Cooper

Scientific Adviser, National Institute for Health and Care Excellence (NICE)
Sophie Cooper is currently a Scientific Adviser in the Science Policy and Research programme at NICE, following several years’ experience in NICE's Technology Appraisals programme. Her role involves developing Institute responses to science policy issues and undertaking and commissioning... Read More →
LL

Linda Landells

Associate Director Technology Appraisals (Cancer Drugs Fund), National Institute for Health and Care Excellence (NICE)
IL

Iain Leslie

Health Outcomes Manager, Communications, Policy and Access Directorate, F. Hoffmann-La Roche
SP

Stephen Palmer

Professor, University of York
avatar for Bettina Ryll

Bettina Ryll

Chair ESMO Patient Advocates Working Group (PAWG), Melanoma Patients
Bettina Ryll, MD/PhD founded the Melanoma Patient Network Europe in 2013 and developed a special interest in patient-centric clinical research and drug development. Bettina’s current areas of focus are Adaptive Licensing/ MAPPS , innovative sustainable healthcare models and patient-centered... Read More →
avatar for Anja Schiel

Anja Schiel

Senior Adviser/Statistician, Unit for HTA and Reimbursement, Norwegian Medicines Agency (NoMA)
Anja Schiel is working as Senior Advisor and Statistician for Norwegian Medicines Agency (NoMA. She has studied Biology at the Johannes Gutenberg-University Mainz, holds a PhD from the Free University Amsterdam and has many years of experience in medical research. Since 2017, she... Read More →


Thursday February 7, 2019 10:45 - 11:45
DIAlogue Space Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Value and Access
  • Tags Session

10:45

#S0706: Can We Improve Patient Experience with Digitisation – Part 2: Digital Devices
Component Type: Session

Digital devices are increasingly used in clinical trial execution – and certainly around Phase 4 studies. While these enable remote trials and collection of new clinical end points, they do not always take into account the view of the patient (e.g., patient comfort) and may not therefore enhance compliance. Listen to concrete examples on how to improve patient experience and retention.

Chair

Valdo Arnera, DrMed, MD

Speaker

Medical Devices and mHealth - Bridging Trial and Health Care and Putting Patients at the Center of Clinical Research
Bruce Hellman, MBA

Deploying a Digital Platform Optimising Patient Monitoring, Compliance and Retention – Uses Cases
Julia Lakeland

Validating Digital Mobility Outcomes as Clinical Endpoints – Easier Said than Done?
Beatrix Vereijken, PhD, MSc



Speakers
avatar for Valdo Arnera

Valdo Arnera

General Manager, Europe, ERT
An MD by training, Valdo has 30+ years of experience in the pharma industry. After having practiced medicine, he started in the industry as a clinical pharmacologist at Ciba-Geigy. He then founded the 1st European Central Clinical Lab for clinical trials, SciCor (now Covance Central... Read More →
avatar for Bruce Hellman

Bruce Hellman

CEO and Co-founder, uMotif
Bruce is the CEO of uMotif and co-founded the company in 2012. He and his team have developed the leading platform for real-world and observational research – a modern data capture platform that patients love to use. Bruce began his career working in clinical trials at British Biotech... Read More →
avatar for Julia Lakeland

Julia Lakeland

Product Director, PAREXEL
Julia is a Product Director at PAREXEL who is passionate about improving the patient experience within the Clinical Trial. She has 20 years experience in industry and plays a key role in identifying and understanding market problems, managing the product portfolio life cycle and leading... Read More →
avatar for Beatrix Vereijken

Beatrix Vereijken

Professor, Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology
Beatrix Vereijken is Professor in Medicine/Movement Science at the Norwegian University of Science and Technology in Trondheim, Norway. She has a PhD in Human Movement Science and a Master degree in Experimental Psychology, both from the Netherlands. She has long-standing expertise... Read More →


Thursday February 7, 2019 10:45 - 11:45
F2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Data and Data Standards
  • Tags Session

10:45

#S0806: The Eurasian Union - Reflection on the Changes in Regulatory and Ways of Working
Component Type: Session

The first EEU regional submissions procedures have been kicked off and regulators as well as companies are gaining their first experiences. Where do we stand and what needs to be addressed to ensure smooth implementation of procedures and guidelines? We will outline the EEU regulatory framework and recent changes / challenges within EEU and Russia regulations Illustrate experience gained during first submissions/approvals by sharing regulators and industry perspective Identify what to do better and how

Chair

Susanne Ausborn, PhD

Speaker

Implementing the Eurasian Regulatory System - Where Do We Stand and How Do We Prepare for the New Developments Addressing Unmet Medical Need
Rustam Abdussalamov, SR, MPA

Implementing the Eurasian Regulatory System - Where Do We Stand and How Do We Prepare for the New Developments Addressing Unmet Medical Need
Dmitriy Goryachev, DrMed, PhD

Panel Discussion
Elena Popova, DrMed

Panel Discussion
Florent Hartmann, PharmD, MS

Panel Discussion
Tomas Salmonson, PhD



Speakers
avatar for Rustam Abdussalamov

Rustam Abdussalamov

Chief Development Officer, National Center For Expertise of Medicines, Medical Devices and Medical Equipmen
avatar for Susanne Ausborn

Susanne Ausborn

Regulatory Policy Lead, Hoffmann-La Roche Ltd
M.Sci. in Analytical Chemistry, PhD in Biophysical Chemistry with Roche since 2001 currently Head Regulatory Policy & International Operation EEMEA, extensive experience with global filings, strong advocate for global regulatory convergence, engaged in numerous workshops/ meetings... Read More →
avatar for Dmitriy Goryachev

Dmitriy Goryachev

Director, Center of Expertise and Quality Control of Medicinal Products, Moh Russian Feder
I graduated from the Moscow Sechenov Medical Academy in 1995. I worked as a research doctor at the Institute of Rheumatology of the Russian Academy of Medical Sciences. Since 2003 - employee of the Center of expertise. The main area of work was related to the evaluation of painkillers... Read More →
avatar for Florent Hartmann

Florent Hartmann

Regulatory Sub-Region Head, Novartis Pharma AG
Florent Hartmann is currently Regulatory Sub-Region Head at Novartis, responsible for regulatory oversight of Region Europe countries including Eurasian Economic Union. He is a pharmacist with over 12 years of experience in global Regulatory Affairs, including drug development, clinical... Read More →
avatar for Elena Popova

Elena Popova

Senior Director Regulatory Affairs & Healthcare Policy, Association of International Pharmaceutical Manufacturers (AIPM)
Elena has broad experience in R&D, RA, business development, and healthcare policy. She graduated from Russian State Medical University, holds PhD degree in medicine, and eMBA degree in Strategic Management from University of Antwerp, Belgium. Elena in her role in AIPM is responsible... Read More →
avatar for Tomas Salmonson

Tomas Salmonson

Senior Scientific Advisor, Medical Products Agency (MPA)
Tomas Salmonson, M.Sc., PhD, brings outstanding experience and expertise from a long career in the regulation of medicines both on a national and European level to his new role. A pharmacist by training, he is currently senior scientific advisor at the Swedish Medical Products Agency... Read More →


Thursday February 7, 2019 10:45 - 11:45
K2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Regulatory Science
  • Tags Session

10:45

#S0906: ICH Info Day – Part 1
Component Type: Session

The International Council for Harmonisation (ICH) held its last meeting in Charlotte, NC, USA on 10-15 November 2018. Three years on from the reform of ICH, all organisational changes have been implemented, with the Charlotte meeting being illustrative of ICH’s steady evolution to a more global initiative. This is evidenced by the fact that ICH is now constituted by 16 Members and 28 Observers with harmonisation efforts ongoing in 25 Working Groups which currently involve over 600 experts. Participants will learn about the recent developments of the ICH Association both regarding strategic initiatives such as ICH’s approach to training and the implementation of ICH guidelines as well as regarding technical guidelines. Part 1 of the ICH Info Day includes a presentation describing the ICH focus on managing the continued efficiency of the ICH process and facilitating a harmonized implementation of ICH guidelines as well as a presentation of the recently agreed new quality topic, Q13 on Continuous Manufacturing.

Chair

Petra Doerr, PharmD, RPh

Speaker

Introduction
Petra Doerr, PharmD, RPh

What’s New in ICH? Membership/Implementation/Training
Lenita Lindström-Gommers, LLM

Continuous Manufacturing Q13
Wendy L Zwolenski-Lambert, MSc



Speakers
avatar for Petra Doerr

Petra Doerr

Deputy Executive Director, Swissmedic
Since January 2014 Head of Communication and Networking and Deputy Executive Director at Swissmedic, Swiss Agency for Therapeutic Products. Oversees the international cooperation with other agencies and international organisations. Member of the ICH Management Committee & Vice-chair... Read More →
avatar for Lenita Lindström-Gommers

Lenita Lindström-Gommers

ICH Assembly Chair and Senior Expert, European Commission, European Commission
ICH Assembly Chair Senior Policy Officer in DG SANTE/European Commission dealing with international relations in the field of pharmaceuticals
avatar for Wendy Zwolenski-Lambert

Wendy Zwolenski-Lambert

Director Regulatory Affairs, Novartis
Wendy Zwolenski-Lambert Wendy Zwolenski-Lambert is the Efpia topic lead on the ICH Q13 Continuous Manufacturing Expert Working Group. Following a decade working in medical devices and drug delivery systems, she moved to biopharmaceutical manufacturing of monoclonal antibodies. She... Read More →


Thursday February 7, 2019 10:45 - 11:45
K1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

10:45

#LOT05: Patient Advocacy, Next Generation of Young Patient advocates and Why Patient Advocacy Matters
Component Type: Session

Why is patient advocacy the stepping stone to better healthcare for all stakeholders today?

Chair

Lyudmil Ninov

Speaker

Why is patient advocacy the stepping stone to better healthcare for all stakeholders today?
Valentina Strammiello, MA

Panelist
Lembe Kullamaa

Panelist
Lyudmil Ninov

Panelist
Kirsty Wydenbach, DrMed, MSc



Speakers
avatar for Valentina Strammiello

Valentina Strammiello

Senior Programme Manager, European Patients' Forum
Valentina Strammiello joined EPF in late January 2013. She holds a BA in International Relations and a Master’s Degree in European Studies. She works as Senior Programme Manager and oversees the EPF project portfolio and Youth Strategy. She represents EPF in HTA-related activities... Read More →
LK

Lembe Kullamaa

Representative Estonian Chamber of Disabled People at EPF Youth Group, European Patients' Forum
Lembe is an undergraduate student in Sociology with minors in Biology. Her main interest is in addressing problems for young patients’ in the healthcare system. Lembe was diagnosed with Juvenile Idiopathic Arthritis when she was seven years old. From an early age on, she has volunteered... Read More →
avatar for Lyudmil Ninov

Lyudmil Ninov

Project Officer and EPF Youth Group Coordinator, European Patients' Forum (EPF)
EPF Project Officer and EPF Youth Group Coordinator. Lyudmil focuses mainly on: the EC PRO-STEP tender project (EPF-led), Annual Summer Training for Young Patient Advocates Leadership Programme, contributing to H2020 project proposals/calls and day-to-day management of DigitalHealthEurope... Read More →
avatar for Kirsty Wydenbach

Kirsty Wydenbach

Deputy Unit Manager, Clinical Trials Unit, MHRA
Joined MHRA in 2009, as the Senior Medical Assessor and Deputy Unit Manager in the Clinical Trials Unit. Involved in the UK regulation of clinical trials across all therapy areas and all phases of development, including trials for chemical and biological products, Advanced Therapy... Read More →


Thursday February 7, 2019 10:45 - 11:45
0.96-0.97 (Level 0) Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

12:00

#S0107: Comparing Apples with Oranges: How EU and US Expedited Regulatory Pathways Differ in Practice - Learnings, Reflections and Future Trends
Component Type: Session

This session will compare recent hands-on experience with expedited regulatory pathways in EU and US (e.g. PRIME, Breakthrough Designation and beyond) both from the regulators’ and sponsor’s viewpoint. It will also include broader stakeholders’ perspectives on the present and future of these regulatory tools. A panel debate will be structured around statements that both panelists and the audience will be able to vote upon with the aim of inspiring honest discussion on the real benefits, drawbacks and future opportunities of these regulatory tools in the EU, US and globally.

Chair

Tiia Metiäinen, MPharm
Nadia Assenova, MBA, MPharm, MS

Speaker

Case Study: Recent Experience with US Breakthrough and EU PRIME Designations – Reflections and Learnings from the Applicant’s Perspective
Carol Pitcher-Towner, PhD

Health Authority Perspectives on Expedited Pathways: Reflection on Experience to Date, Stakeholder Collaboration and Future Trends
Sandra L. Kweder, MD

Experience and Reflections on PRIME from CHMP Perspective– Most Common Challenges, Opportunities for Stakeholder Collaboration and Possible Future Evolution of the Programme
Milena Stain, MD

Panel Discussion
Murray M. Lumpkin, DIAFellow, MD, MSc



Speakers
avatar for Nadia Assenova

Nadia Assenova

Head Regulatory Affairs Europe, Sage Therapeutics
Nadia Assenova MPharm, MBA, MSc is Head of Regulatory Affairs Europe at Sage Pharmaceuticals GmbH. She has more than 15 years of global regulatory strategy experience spanning across a variety of therapeutic areas and development stages. Nadia started her career at Novartis Pharma... Read More →
avatar for Sandra Kweder

Sandra Kweder

Deputy Director, Liaison to the EMA, Office of International Programs, OC, FDA
Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA Office of International Programs. Dr. Kweder previously served for more than a decade as Deputy Director, Office of New Drugs, in FDA’s Center for Drug Evaluation & Research, where she actively led numerous... Read More →
avatar for Murray Lumpkin

Murray Lumpkin

Deputy Director, Regulatory Affairs, Lead Global Regulatory Systems Initiatives, Bill and Melinda Gates Foundation
Murray M. Lumpkin, MD, serves as Deputy Director, Integrated Development, and Lead for Global Regulatory Systems Initiatives, for The Bill & Melinda Gates Foundation, working to improve the efficiency and effectiveness of regulatory processes in low- and middle-income countries. He... Read More →
avatar for Tiia Metiäinen

Tiia Metiäinen

Specialist, Regulatory Science & Advocacy, Lundbeck
Tiia Metiäinen is currently working as Specialist, Regulatory Science and Advocacy at Lundbeck headquarters in Copenhagen, focusing on regulatory policy and intelligence from a global development angle. H. Lundbeck A/S is a global pharmaceutical company specialized in psychiatric... Read More →
CP

Carol Pitcher-Towner

VP, EU Regulatory Affairs, Alnylam Pharmaceuticals
Carol Pitcher-Towner is Head of International Regulatory Affairs at Alnylam. Alnylam is leading the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of patients who have limited or inadequate treatment... Read More →
avatar for Milena Stain

Milena Stain

AT CHMP Alternate Member, BASG
Milena Stain joined the Austrian Federal Office for Safety in Health Care in 2006. She is working in the Scientific Office, which focusses on centralised European procedures during drug development, marketing authorisation and life-cycle management. Since 2009 she is the Austrian... Read More →


Thursday February 7, 2019 12:00 - 13:15
E1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Regulatory Science
  • Tags Session

12:00

#S0307: Capacity Building and Capability Building in Pharmacovigilance
Component Type: Session

The session will discuss the importance and components of defining roles and designing a competency framework in a global pharmacovigilance system.

Chair

Shelley Gandhi, MSc

Speaker

Capacity and Capability Building in PV- Large Pharma Experience
Elizabeth Hancox, DrMed, FFPM

Capability and Capacity Building, Competency Model for PV Organisation
Preeti Verma, DrMed, MD

Global PV System – What Does This Mean when Preparing for an Inspection?
Wendy Huisman, PharmD



Speakers
avatar for Shelley Gandhi

Shelley Gandhi

Strategic Advisor, NDA Group
Shelley is an experienced and highly motivated pharmacovigilance and risk management expert, with an international reputation in her field, specialising in delivering global safety solutions including safety governance models. Former senior manager at MHRA for over 19 years and represented... Read More →
avatar for Elizabeth Hancox

Elizabeth Hancox

Deputy QPPV and Head of Safety Governance, GSK
Dr Elizabeth Hancox has completed specialist training in Pharmaceutical Medicine and has over 18 years of experience in Industry. She is Deputy QPPV and Head of Safety Governance at GSK and has worked at GSK for 10 years in a variety of safety roles including materiovigilance and... Read More →
avatar for Wendy Huisman

Wendy Huisman

Vigifit
Wendy worked the last 15 years as (deputy) EU QPPV for Teva. She gained broad experience in a pharmacovigilance in complex organisations. Starting in 2005 Wendy built the pharmacovigilance working group of Medicines for Europe from almost nothing to the respected counterpart for the... Read More →
avatar for Preeti Verma

Preeti Verma

AVP, Pharmacovigilance, APCER Life Sciences
Dr. Preeti Verma is an MS in OBG with over 13 years of experience in Medicine and PVG. She is Associate Vice President, Pharmacovigilance Operations at APCER.Before joining APCER, she was the Associate Director for Pharmacovigilance,Kinapse.She heads Medical Safety,EU along working... Read More →


Thursday February 7, 2019 12:00 - 13:15
E2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Pharmacovigilance
  • Tags Session

12:00

#S0407: What Do These Buzzwords Mean – for Me? Artificial Intelligence, Big Data Mining, Machine Learning, Quantum Computing…
Component Type: Session



Chair

Peter Schueler, DrMed, MD

Speaker

Artificial Intelligence & Blockchain Technology
Srinivas Karri, MSc

Big Data
Frederik Floether, PhD, MA, MSc

Machine Learning
Richard Davies



Speakers
avatar for Peter Schueler

Peter Schueler

Senior Vice President, Drug Development Neurosciences, ICON plc (CRO)
Peter Schüeler, MD, serves as Senior Vice President, Drug Development Neurosciences, for ICON plc (Germany). He joined ICON as Vice President for Medical Affairs and Drug Safety for Europe, and has authored an eBook about drug development methodology. Dr. Schüeler is Head Lecturer... Read More →
avatar for Richard Davies

Richard Davies

Vice President, Solution Expert, CluePoints
Richard Davies joined CluePoints in September 2018 and is based in the UK. As VP, Solution Expert his role is to support organizations’ adopting CluePoints solutions from a technical, functional and business process perspective, particularly as they execute their vendor selection... Read More →
avatar for Frederik Floether

Frederik Floether

IBM Q Consulting Global Life Sciences Leader, Quantum & AI, IBM
avatar for Srinivas Karri

Srinivas Karri

Senior Director, Clinical Warehousing Cloud Strategy, Oracle Corporation
As an industry strategy lead for clinical data cloud based applications, I help identify, define and create new services to support management of clinical data using cloud based technologies and capabilities. I have over 20 years experience with developing, implementing, selling and... Read More →


Thursday February 7, 2019 12:00 - 13:15
DIAlogue Space Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Clinical Development
  • Tags Session

12:00

#S0507: Hey Siri, I Am Not Feeling Well Today
Component Type: Session

Digital technologies and the internet have had huge impact on the accessibility to data and knowledge and in the way in which we communicate in professional and home life. Expert systems already provide healthcare professionals with the ability to analyse large amounts of data, alerting them to abnormal test results, helping with diagnoses or providing therapy recommendations. Social media and networking systems have also become powerful communication tools. How is medical information within the pharmaceutical industry embracing these digital technologies to improve accessibility to data and the way we communicate with our customers? Does the Med Info Service need to change to keep step with the digital evolution in information provision outside pharma? What will a medical information service look like in 2030? This session will explore these questions and many more in engaging dialogue and interviews with our expert medical information professional panel.

Chair

Jill Voss, MSc

Speaker

Panel Discussion
Ian Hamilton

Panel Discussion
Isabelle C. Widmer, DrMed

Panel Discussion
Gavin Lyndon, PhD

Panel Discussion
Suzanne C. Meenan



Speakers
avatar for Jill Voss

Jill Voss

Scientific Communications Director, Novartis Pharma AG
Jill is a medical information professional with more than 25 years’ experience in international, regional and affiliate roles in large and small pharmaceutical companies, as well as 9 years providing strategic business and medical consultancy services. Jill has held leadership roles... Read More →
avatar for Ian Hamilton

Ian Hamilton

Medical Affairs Global IT Account Manager, Eli Lilly and Company
Ian’s academic background is in Electronic Engineering but has worked in the Pharmaceutical industry for over 30 years, with the last five years being focused on providing IT consultancy to the Global Medical Affairs area at Eli Lilly & Company. In his current role for Lilly he... Read More →
avatar for Gavin Lyndon

Gavin Lyndon

Global Lead, Content Strategy and Management – Medical Information, Pfizer
Gavin Lyndon is an experienced medical affairs professional, with over 17 years in the pharmaceutical industry. After completing his PhD in pharmacology at the University of Bath, UK, Gavin joined the Medical Information department at Pfizer Ltd in 2001. He then moved into UK Medical... Read More →
avatar for Suzanne Meenan

Suzanne Meenan

Medical Information Group Lead, Roche Products Ltd, UK
As a Medical Information Group lead, she manages the Medical Information and Library functions. She has been involved in the development of the company’s healthcare professional portal and the recent re-launch of the Roche UK website. Suzanne has a degree in Biochemistry and a post-graduate... Read More →
avatar for Isabelle Widmer

Isabelle Widmer

Medical Affairs Consultant, elytra GmbH
Isabelle Widmer, MD is a life science consultant based in Europe. Isabelle supports teams in both Fortune 500 companies and biotech to deliver global transformation programmes in Medical Affairs and Med Info. Combining an entrepreneurial mindset, analytical and project management... Read More →


Thursday February 7, 2019 12:00 - 13:15
G2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

12:00

#S0607: Assessing the Value of a Cure: Are HTA Approaches and Payment Models Fit for Purpose?
Component Type: Session

In this session we discuss how to prove value, establish a price, payment models

Chair

Koen Torfs

Speaker

Panel discussion
Charlotte Anderberg, PhD, MSc

Panel discussion
Francis Arickx

Panel discussion
Michael Schlander

Panel discussion
Steve Wooding

Panel discussion
Olivier Wong, MD



Speakers
avatar for Charlotte Anderberg

Charlotte Anderberg

Pharmaceutical Assessor, Dental and Pharmaceutical Benefits Agency
Charlotte Anderberg, PhD, MSc, works as a Pharmaceutical Assessor at the Dental and Pharmaceutical Benefits Agency, TLV, in Stockholm. She has a PhD in Medical Science based on her work on the tumor microenvironment and an MSc in Biomedicine, both from Karolinska Institutet. At TLV... Read More →
avatar for Francis Arickx

Francis Arickx

Head of the Directorate Pharmaceutical Policy, National Institute for Health and Disability Insurance (RIZIV-INAMI)
Francis Arickx is head of the directorate Reimbursement of Medicines and Pharmaceutical Policy within the Health Care Department at the National Institute for Health and Disability Insurance (NIHDI RIZIV/INAMI) in Belgium. He manages administrative and scientific assessments, and... Read More →
MS

Michael Schlander

Head of the Division of Health Economics, German Cancer Research Center (DKFZ)
KT

Koen Torfs

Head of Market Access & Pricing, Actelion
avatar for Olivier Wong

Olivier Wong

CMO, Medi-Qualite Omega
Olivier Wong is Chief Medical Officer at Medi-Qualité Omega (M?Q), France, and an HTA expert. He was a voting member of the Transparency Committee (French national HTA and reimbursement committee with 13 years in office and former fully pledged member of the French National Payer... Read More →
SW

Steve Wooding

Head, Global Commercial and Market Access Strategy Organisation, Janssen


Thursday February 7, 2019 12:00 - 13:15
G1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Value and Access
  • Tags Session

12:00

#S0707: Preparing the Way for a Learning Healthcare Ecosystem
Component Type: Session

A learning healthcare system will connect available health data from multiple sources and ensure feedback from this data is used to enhance future medicine development, improve use of medicines and enhance the overall health of European citizens. Hear from those helping to advance the improvement of this ecosystem.

Chair

Emma Du Four, MBA

Speaker

Vision for a Learning Healthcare Ecosystem –– Signature Digital Health Initiatives: How They Fit Together as Enablers to Each Other
Thomas Metcalfe, MBA

Panel Discussion
Elena Bonfiglioli

Panel Discussion
Magda Chlebus, MA



Speakers
EB

Elena Bonfiglioli

Managing Director, Health and Life Sciences, Microsoft
MC

Magda Chlebus

Executive Director Science Policy & Regulatory Affairs, EFPIA
Magda Chlebus is Executive Director Science Policy & Regulatory Affairs at the European Federation of Pharmaceutical Industries and Associations (EFPIA), representing the R&D-based pharmaceutical industry in Europe. | Magda and her team are in charge of following policy and legislative... Read More →
avatar for Emma Du Four

Emma Du Four

Head of International Regulatory Policy, Abbvie
Emma Du Four has extensive global experience in the biopharmaceutical industry encompassing product development, clinical trials, real world evidence, paediatric medicines, biotherapeutics, devices, pharmacovigilance, policy and strategy development. Emma currently serves as Head... Read More →
avatar for Thomas Metcalfe

Thomas Metcalfe

Data Policy Leader, Personalised Healthcare, F. Hoffmann-La Roche
Tom Metcalfe graduated in Biochem from King's in London and has an MBA from the Open University. He currently works as a Data Policy Leader in Roche Pharma's Personalised Healthcare Centre of Excellence. Prior to that he worked for Roche as a Strategic Innovation Leader in Global... Read More →


Thursday February 7, 2019 12:00 - 13:15
F2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Data and Data Standards
  • Tags Session

12:00

#S0807: Strengthening the Supply Chain to Improve Access to Medicines in Africa
Component Type: Session

Session in development

Chair

Greg Perry

Speaker

Panelist
Winnie Nganga

Panelist
Lisa Hedman, MBA, MHA

Panelist
Elisa Zwaneveld

Panelist
Alastair West



Speakers
LH

Lisa Hedman

World Health Organisation
Ms Hedman works with the WHO Department of Essential Medicines and Health Products, specializing in initiatives to promote access to medicines, as well as capcity development in procurement and supply chain for medicines. Prior to joining WHO, she worked with governments, NGOs on... Read More →
WN

Winnie Nganga

Regulatory and Quality Manager, GSK
GP

Greg Perry

Assistant Director General, IFPMA
AW

Alastair West

Business Plan Coordinator, United Nations Industrial Development Organization


Thursday February 7, 2019 12:00 - 13:15
K2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

12:00

#S0907: ICH Info Day – Part 2
Component Type: Session

Part 2 of the ICH Info Day focuses on the Safety guideline S1 on criteria for when to conduct rodent carcinogenicity studies and on the Efficacy guideline E8 as the first step towards the GCP renovation initiated in 2017.

Chair

Pär Tellner, MSc

Speaker

Introduction
Pär Tellner, MSc

Carcinogenicity Studies S1
Tania Cecilia Cavaliero, DVM

General Considerations for Clinical Trials E8 (GCP Renovation)
Fergus Sweeney, PhD



Speakers
avatar for Tania Cecilia Cavaliero

Tania Cecilia Cavaliero

Preclinical Assessor, Swissmedic
Tania Cavaliero is Preclinical Assessor at Swissmedic since 2010. Before this role, she worked in research, early development and project management in the animal health pharmaceutical industry. She is member of the ICH S1 (R1) expert working group.
avatar for Fergus Sweeney

Fergus Sweeney

Head of Inspections and Human Medicines Pharmacovigilance (Division), European Medicines Agency, European Union
PhD in pharmacology 1986 Joined EMEA in 1999. Head of Division, Inspections and Human Medicines Pharmacovigilance
avatar for Pär Tellner

Pär Tellner

EFPIA ICH Coordinator, Director Regulatory Affairs, EFPIA
Pär Tellner is Director EFPIA since 2012 and member of ICH Management Committee and Assembly since 2016. Pär has previously been working as Compliance officer (marketing ethics) and Director of Veterinary Medicine, LIF Sweden and as Head of regulatory affairs for several pharmaceutical... Read More →


Thursday February 7, 2019 12:00 - 13:15
K1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

13:15

#L3: Lunch in the Exhibition Hall
Component Type: Social Event




Thursday February 7, 2019 13:15 - 14:00
Exhibition Hall Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

13:30

#PS07: Oral Poster Session 7 - Clinical Development & Pharmacovigilance Content Hub
Component Type: Session



Speaker

Polycyclic aromatic Hydrocarbons in herbal medicinal Products: T Vavvas and G Bode
Gerd Bode, MD, PhD

Meta-analysis of spontaneous remission percentage in placebo arm of biologic agents in randomized controlled trials for lupus
Clémentine POILROUX, MSc

Adaptive trial design with dose-selection and enrichment for assessing 2-OHOA for treatment of glioblastoma
Ursula Maria Garczarek, DVM, AHIP



Speakers
GB

Gerd Bode

University of Goettingen, Honorable Member of the Medical Faculty, Department of Pharmacology Toxicology
Gerd Bode holds board certified specializations in Pathology, Neuropathology, Legal Medicine, Pharmacology and Toxicology. He works now as a lecturer and independent consultant in Toxicology and Pathology. Gerd was long term ICH Topic Leader for Safety Guidelines.
UG

Ursula Garczarek

Associate Director, Strategic Consulting, Cytel
CP

Clémentine POILROUX

6th year pharmacy and Master degree "Clinical evaluation" student, Claude Bernard University Lyon 1


Thursday February 7, 2019 13:30 - 14:00
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

14:00

#DMD10: Raising Europe’s Voice in Globalising Regulatory Science
Component Type: Session

In this session, we aim to take the long view of regulatory science and innovation in establishing the value of medicines and medical treatments, exploring the heritage of European contributions to this scholarship and practice. However, this is undertaken only in the service of the principal goal of this session: to map out the role that Europe could - and should - play in the global evolution of regulation.

Chair

Virginia Lee Acha, PhD, MSc

Speaker

Panel Discussion
Dimitrios Athanasiou, MBA

Panel Discussion
Marieke De Bruin, PharmD, PhD

Panel Discussion
Sini Eskola, MPharm, MSc

Panel Discussion
Ian Hudson

Panel Discussion
Anthony Humphreys, MPharm



Speakers
avatar for Virginia Acha

Virginia Acha

Executive Director, Global Regulatory Policy, MSD
Virginia (Ginny) has worked in industry and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She recently joined MSD to lead regulatory policy efforts for innovation that will lead to better... Read More →
avatar for Dimitrios Athanasiou

Dimitrios Athanasiou

Patient Advocate, WORLD DUCHENNE ORGANIZATION (WDO) , MDA HELLAS
Dimitrios Athanasiou is a PDCO member representing EURORDIS. He holds a BA and an MBA in Financial Management He attended Eurordis Summer School and European Patient Academy (EUPATI) acquiring basic biotech and regulatory knowledge. As a full time patient advocate in DMD, he is a... Read More →
avatar for Marieke De Bruin

Marieke De Bruin

Director, Copenhagen Centre for Regulatory Science, Copenhagen University
Marieke De Bruin, PhD was trained as a pharmacist and epidemiologist. Her drug regulatory science research has focused on pharmacoepidemiology in the drug regulatory setting and pharmacovigilance. The main clinical areas are cardiovascular diseases and cancer. As of August 2016, she... Read More →
avatar for Sini Eskola

Sini Eskola

Director Regulatory Affairs, European Federation of Pharmaceutical Industries and Associations (EFPIA)
Sini is working as Regulatory, Drug Development and Manufacturing Director at EFPIA since 2014. She leads regulatory policy and advocacy activities on clinical trials and transparency, pharmacovigilance, regulatory information technology and environmental sustainability aspects. She... Read More →
avatar for Ian Hudson

Ian Hudson

Chief Executive, Medicines and Healthcare products Regulatory Agency (MHRA)
Dr Ian Hudson became Chief Executive of the MHRA in September 2013. He is a physician who practiced as a paediatrician prior to working in the pharmaceutical industry in clinical research and development. In 2001 he joined the former Medicines Control Agency as its Licencing Division... Read More →
avatar for Anthony Humphreys

Anthony Humphreys

Head of Scientific Committees Regulatory Science Strategy, European Medicines Agency, European Union
He is the Head of Scientific Committees Regulatory Science Strategy Division (SciRS). He is responsible for providing leadership in the Agency in the areas of Scientific Committees Coordination and Regulatory Science Strategy in support of delivering the EMRN 2020 Strategy. He chairs... Read More →


Thursday February 7, 2019 14:00 - 15:00
E2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Regulatory Science
  • Tags Session

14:00

#DMD11: Modern Clinical Research and Paradigm Shift – What Can We Take Home?
Component Type: Session

The panel will reflect on the previous days’ key messages about “Modern Clinical Research”, such as innovative study design and statistics, patient centricity, digital technologies. The audience will be involved through the voting system.

Chair

Peter Schueler, DrMed, MD

Speaker

Panel Discussion
Janet Valentine, PhD

Panel Discussion
Jan Geissler, MBA

Panel Discussion
Tomas Salmonson, PhD



Speakers
avatar for Jan Geissler

Jan Geissler

CEO, Patvocates
Founder and Managing Director of Patvocates. Former Director of the European Patients' Academy (EUPATI). Cancer survivor and co-founder of the CML Advocates Network, the Leukemia Patient Advocates Foundation, LeukaNET, Leukämie-Online and the European Cancer Patient Coalition.
avatar for Robert Hemmings

Robert Hemmings

Statistics and Pharmacokinetics Unit Manager, Medicines and Healthcare products Regulatory Agency (MHRA)
Rob has been with MHRA for 16 years and heads up the team of statisticians and pharmacokineticists. Much of Rob’s time is spent educating colleagues in the importance and artistry of clinical trial statistics; their use in proof and in obfuscation. Rob is a co-opted member of the... Read More →
avatar for Tomas Salmonson

Tomas Salmonson

Senior Scientific Advisor, Medical Products Agency (MPA)
Tomas Salmonson, M.Sc., PhD, brings outstanding experience and expertise from a long career in the regulation of medicines both on a national and European level to his new role. A pharmacist by training, he is currently senior scientific advisor at the Swedish Medical Products Agency... Read More →
avatar for Peter Schueler

Peter Schueler

Senior Vice President, Drug Development Neurosciences, ICON plc (CRO)
Peter Schüeler, MD, serves as Senior Vice President, Drug Development Neurosciences, for ICON plc (Germany). He joined ICON as Vice President for Medical Affairs and Drug Safety for Europe, and has authored an eBook about drug development methodology. Dr. Schüeler is Head Lecturer... Read More →
avatar for Janet Valentine

Janet Valentine

Director of Clinical Practice Research Datalink (CPRD), MHRA
Janet Valentine PhD joined the Clinical Practice Research Datalink (CPRD) as Director in 2015. CPRD is the UK Government real world health data research service supporting retrospective and prospective public health and clinical studies. Previously Janet was Head of Population Health... Read More →


Thursday February 7, 2019 14:00 - 15:00
F1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Clinical Development
  • Tags Session

15:15

Conference Closer- Rapid Fire Session
This must-attend ‘Rapid Fire’ session is an excellent opportunity to hear what you have missed in the sessions that you could not attend! Topic Leaders will have 4 minutes onstage to share the essence from the presentations and discussions in their topics by delivering summaries of novel insights and key takeaways from the DIA Europe meeting. DIA is capturing emerging knowledge and insights in order to advance selected topics after the meeting.

Moderator:
Thomas Bols, SVP and Managing Director DIA EMEA

Speakers
avatar for Claudine Sapède

Claudine Sapède

Global HTA and Payment Policy Lead, F. Hoffmann-La Roche
Claudine Sapède is Global HTA and Payment Policy Lead at Roche based in Basel. She works on the development of Roche’s external policy positions and projects on market access related subjects including HTA and pricing. She has been working in the field of reimbursement, market... Read More →
avatar for Robert Hemmings

Robert Hemmings

Statistics and Pharmacokinetics Unit Manager, Medicines and Healthcare products Regulatory Agency (MHRA)
Rob has been with MHRA for 16 years and heads up the team of statisticians and pharmacokineticists. Much of Rob’s time is spent educating colleagues in the importance and artistry of clinical trial statistics; their use in proof and in obfuscation. Rob is a co-opted member of the... Read More →
avatar for João Duarte

João Duarte

Associate Director, Regulatory Intelligence, Alexion Pharmaceuticals
João Duarte received his Master degree in Pharmaceutical Science in 2011 from the Faculty of Pharmacy of the University of Lisbon. He is currently Associate Director for Europe Regulatory Policy & Intelligence at Takeda, based in London, where he is responsible for intelligence and... Read More →
EH

Esteban Herrero-Martinez

Director Regulatory Policy and Intelligence, Abbvie Ltd
Previously Director of Regulatory Intelligence and Policy at Daiichi Sankyo Development Ltd, lead for Pharmacovigilance & Regulatory Affairs at the Association of the British Pharmaceutical Industry (ABPI) and Pharmacovigilance Manager at P&G Pharmaceuticals. Education: Biochemistry... Read More →
avatar for Gaby Danan

Gaby Danan

Pharmacovigilance Expert, NA
Gaby Danan, MD, PhD, was the EU Qualified Person for Pharmacovigilance for Sanofi until his 2010 retirement. He has served on the Council for International Organizations of Medical Sciences and International Council on Harmonisation Expert Working Groups, especially as the European... Read More →
avatar for Chris Walker

Chris Walker

Vice President, European Head of Regulatory Affairs, Amgen Ltd
Chris Walker (MSc RA & BSc Hons), is Head of Regulatory Affairs for Europe for Amgen and Head of the UK R&D sites.. Chris is chair of the Digital Health Taskforce at EFPIA, a member of the Innovation BSC & Regulatory Strategy Groups. Chris leads the regulatory strategy team for Amgen’s... Read More →
avatar for Danie Du Plessis

Danie Du Plessis

Managing Director and Owner, The Next Version
After completing his medical studies and a Master’s Degree in Pharmacology in South Africa, Danie spent 3 years working in a primary care setting including his own private practice. He joined the pharmaceutical industry in 1991 and held roles of increasing responsibility and leadership... Read More →


Thursday February 7, 2019 15:15 - 16:15
F2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria