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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 Europe | International - Patient Safety, Bristol Myers Squibb, 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)
Nuria Semis-Costa, MSC
Scientific Specialist (Risk Management), European Medicines Agency, Netherlands
EMA GVP on RMM: Updates from a Regulator
Vicki Edwards, RPH
Vice President, Pharmacovigilance Excellence and International QPPV, Abbvie, United Kingdom
Updates on ICH E2D: Post-Approval Safety Data Management
Martin Huber, MPH, MPHARM
Pharmacovigilance Risk Assessment Committee (PRAC) Vice Chair, Federal Institute for Drugs and Medical Devices (BfArM), Germany
EV/EVDAS: Updates
Elke Stahl, PHD
Senior Expert, Clinical Trials Department, Federal Institute For Drugs and Medical Devices (BfArM), Germany
CTR and Implementing Act
Jean-Christophe Delumeau, MD, PHD
Senior Expert, Institute of Pharmacovigilance, Czech Republic
Updates on ICH E2B
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