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Session 5: Signal Management
Session Chair(s)
Peter De Veene, MD
QPPV, MSD Belgium, Belgium
Vicki Edwards, RPH
Vice President, Pharmacovigilance Excellence and International QPPV, Abbvie, United Kingdom
Mette Stockner, MD
Senior Pharmacovigilance Director, Savara ApS, Denmark
In the last few years, signal management requirements have become more international and at the same time more complex. Regulatory authorities across the world have introduced regulations covering signal management varying from information sharing to specific local signal detection requirements. At the same time, a number of initiatives in Europe and the US have changed the way we are managing data and how these data can be used either in the signal detection process as well as the evaluation of signals. This session will provide some practical examples of different data sources and how they can be used. And we will learn how we can cope with the additional local requirements without compromising the global processes.
Speaker(s)
Jean Kilgour-Christie, BSN, MSC
Deputy EU QPPV Head, UK QPPV, Sandoz International GmbH, Germany
Local Signal Detection requirements and their Impact on the Global Signal Detection Process
Jose Alberto Ayala Ortiz, MPHARM, MSC
CEO, PVpharm, Spain
eRMR: Dummy Guide
Carla Rodriguez-Watson, MPH
Director of Research, Reagan-Udall Foundation for the FDA, United States
Sentinel use for signal detection
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