DIA Europe 2019: Full Schedule

13:30 CET

#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 CET
Content Hub 4 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

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15:30 CET

#CHS04: Accelerating Clinical Study Start Up with Innovative Technologies

Component Type: Session

Chair

Evi Cohen, MBA, MS

Speakers

Evi Cohen

Global Industry Leader Life Sciences, Appian, United States

Evi is the Life Sciences Industry Leader at Appian. He is an experienced pharmaceutical executive with an extensive background developing global business portfolios with emphasis on new products, technologies, and IP. Previously, as Global Head of Life Sciences at ServiceNow Evi lead... Read More →

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

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10:15 CET

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

Component Type: Session

Chair

Carmen Arques

Speakers

Carmen Arques

Pharmacovigilance Manager, AZIERTA

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

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10:45 CET

#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

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 CET
Content Hub 1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

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10:45 CET

#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

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 CET
Content Hub 3 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

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11:15 CET

#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

James Duhig

Director, Patient Integration, AbbVie, United States

Dr. James (Jay) Duhig, Ph.D., is director of Patient Integration for AbbVie Pharmacovigilance and Patient Safety. Dr. Duhig is an expert in the application of human factors and health literacy in the investigation of medication errors and in the development of drug and device instructional... Read More →

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

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11:15 CET

#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

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 CET
Content Hub 3 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

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11:15 CET

#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

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 CET
Content Hub 4 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

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12:00 CET

#CH103: EUPATI Update

Component Type: Session

Chair

Matthew May, MS

Speakers

Matthew May

Programme Coordinator, EUPATI Project, EUPATI

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

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12:00 CET

#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 CET
Content Hub 4 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

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12:30 CET

#CH406: Unmet Medical Need Papers

Component Type: Session

Chair

Rick Vreman

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

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14:45 CET

#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

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 CET
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

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15:15 CET

#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

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 CET
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

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15:15 CET

#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

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 CET
Content Hub 4 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

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15:45 CET

#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

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 CET
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

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15:45 CET

#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

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 CET
Content Hub 4 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

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16:45 CET

#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

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 CET
Content Hub 3 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

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17:15 CET

#CH304: New Changes to the National Drug Code in the U.S.

Component Type: Session
Level: Intermediate

Chair

Leyla Rahjou-Esfandiary, PharmD

Speakers

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 CET
Content Hub 3 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

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09:15 CET

#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 CET
Content Hub 1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

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09:15 CET

#CH203: Innovation in Pharmacovigilance

Component Type: Session
Level: Intermediate

Chair

Christian Mueller, DrSc

Speakers

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 CET
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

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09:15 CET

#CH305: Data’s Revenge

Component Type: Session
Level: Basic

Chair

Olaf Schoepke, PhD

Speakers

Olaf Schoepke

Vice President, Regulatory Solutions, Instem, United Kingdom

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 →

Olaf Schoepke

VP Regulatory Solutions, Samarind, Instem

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

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09:45 CET

#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

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 CET
Content Hub 1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

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09:45 CET

#CH204: Innovative Designs under the New Clinical Trials Regulations

Component Type: Session

Chair

Kirsty Wydenbach, DrMed, MSc

Speakers

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 CET
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

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09:45 CET

#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

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 CET
Content Hub 3 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

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09:45 CET

#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

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 CET
Content Hub 4 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

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10:15 CET

#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 CET
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria

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