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Session 1: Premarketing Reporting Obligations in EU and US
Session Chair(s)
Sylvie Tomczyk, MD, PhD
Senior Medical Director
EMD Serono, United States
This session will describe the safety reporting requirements for drugs prior to market approval in the US and the EU region. This will help understand the key obligations and key differences between US and EU regions on individual and aggregate reporting to Health Authorities, IRB or investigators, clinical trial registration, signal detection and special reporting situations for development drugs.
Speaker(s)
Overview of Premarketing Safety Reporting Obligations in the US
Michael Keatley
Janssen Scientific Affairs, LLC, United States
Director, Local Safety Officer
Overview of Premarketing Safety Reporting Obligations in Europe
Vicki Edwards, RPh
Abbvie, United Kingdom
Vice President, Pharmacovigilance Excellence and International QPPV
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