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Post-Authorisation Safety and Efficacy Studies: Operational Challenges and Factors for Success
Session Chair(s)
Corinne de Vries, MA
EMA liaison official to the US FDA, European Medicines Agency, Netherlands
Post-Authorisation Safety and Efficacy Studies: Operational Challenges and Factors for Success
Speaker(s)
Carrying Out Joint Studies between Multiple Companies: Lessons Learnt
Stephanie Tcherny- Lessenot, MD, MPH, MSc
Head of Benefit-Risk Evaluation, Epidemiology & Benefit-Risk Evaluation, Sanofi, France
How Best to Develop Your Pharmacovigilance Plan - PRAC Experience with PASS Protocols
Valerie Strassmann, PhD, RPh
Scientific Administrator, Data Analytics and Methods Task Force, European Medicines Agency (EMA), Netherlands
How Can We Facilitate the Conduct of Studies: A Regulator’s Perspective
Peter Richard Arlett, MD, FFPM, FRCP
Head Data Analytics and Methods Task Force, European Medicines Agency, Netherlands
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