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Tuesday, February 5
 

12:30 CET

#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 CET
Content Hub 3 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  Poster Session, Session

13:30 CET

#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, United Kingdom
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 CET
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  Poster Session, Session

15:30 CET

#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 CET
Content Hub 1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  Poster Session, Session
 
Wednesday, February 6
 

10:15 CET

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

14:15 CET

#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

Postdoctoral Fellow, Rutgers University/Ernest Mario School of Pharmacy
Kenneth is a Global Regulatory Affairs Fellow with the Rutgers Pharmaceutical Industry Fellowship Program. As a Fellow he has worked in Regulatory Science and Policy, Strategy, and Advertising and Promotion across I&I, oncology, and primary care while also gaining insight into digital... Read More →

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

16:15 CET

#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

ClinOps Director, 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 CET
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  Poster Session, Session
 
Thursday, February 7
 

13:30 CET

#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 CET
Content Hub 2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  Poster Session, Session
 
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  • 01 Stakeholders and Regulatory System Optimisation
  • 02 Evolution of Science and Policy
  • 03 Pharmacovigilance
  • 04 Modern Clinical Research
  • 05 Medical Affairs and Communication
  • 06 Access to Medicines
  • 07 Digital Disruptors
  • 08 Regional Updates
  • Conference Closer
  • Content Hub
  • DIAmond Sessions
  • Executive Forum
  • Hot Topics/Stand Alone
  • ICH Info Day
  • Keynote
  • Leader of Tomorrow
  • Networking
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  • Women in Leadership