戻る Agenda
Post-Authorisation Safety and Efficacy Studies: Operational Challenges and Factors for Success
Session Chair(s)
Corinne de Vries, PHD, MA, MSC
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
Sanofi, France
Head of Benefit-Risk Evaluation, Epidemiology & Benefit-Risk Evaluation
How Best to Develop Your Pharmacovigilance Plan - PRAC Experience with PASS Protocols
Valerie Strassmann, PHD, RPH
European Medicines Agency (EMA), Netherlands
Scientific Administrator, Data Analytics and Methods Task Force
How Can We Facilitate the Conduct of Studies: A Regulator’s Perspective
Peter Richard Arlett, MD, FFPM, FRCP
European Medicines Agency, Netherlands
Head Data Analytics and Methods Task Force