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Session 1: Pharmacovigilance Guidelines And Regulations Updates (EU, Non-EU, Global)
Session Chair(s)
Maarten Lagendijk, MSc
Deputy EU QPPV
MSD, Netherlands
Willemijn van der Spuij, MSc
Executive Director, WorldWide Patient Safety International, Europe
Switzerland
This session looks to explore multiple aspects of regulatory changes that impact Patient Safety and Pharmacovigilance activities from different regions around the world. Multiple PV topics will be addressed; starting with an FDA perspective on combination product regulations followed by an update on the EMA GVP for RMM; the next topic will cover ICH E2D activities and specifically an update on the discussions that are taking place; the latest on EV monitoring for signals and the industry experience; an update on the Clinical Trial Regulation that is nearing its implementation; and finally, an update on the ICH E2B activities in an international context. A lot of work is taking place in the emerging markets to promote ICHE2B standards, so the final topic in this session will be truly international.
Speaker(s)
EMA GVP on RMM: Updates from a Regulator
Nuria Semis-Costa, MSc
European Medicines Agency, Netherlands
Scientific Specialist (Risk Management)
Updates on ICH E2D: Post-Approval Safety Data Management
Vicki Edwards, RPh
Abbvie, United Kingdom
Vice President, Pharmacovigilance Excellence and International QPPV
EV/EVDAS: Updates
Martin Huber, MPH, MPharm
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Pharmacovigilance Risk Assessment Committee (PRAC) Vice Chair
CTR and Implementing Act
Elke Stahl, PhD
Federal Institute For Drugs and Medical Devices (BfArM), Germany
Senior Expert, Clinical Trials Department
Updates on ICH E2B
Jean-Christophe Delumeau, MD, PhD
Institute of Pharmacovigilance, Czech Republic
Senior Expert
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