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Session 6: Signal Detection
Session Chair(s)
Bruce Valliant
Head of Pharmacovigilance and Medical Information, Pharmascience Inc., Canada
Methods selected for detection of safety signals for a drug are dependent upon the safety profile of the drugs. The safety profile will also have a direct impact on how many reports of adverse drug reactions would be received over a given time period. The expectedness, quantity, seriousness and severity of such reports will all impact on the methods to be used in the signal detection process. As well, the capacity of a small pharmaceutical company to undertake a robust signal detection process may be somewhat limited as compared with that of a large multi-national corporation. Presentations will consider the effectiveness of various methodologies based on these scenarios and compare that with expectations of the regulatory authorities.
Learning Objective : At the conclusion of this session, participants should be able to:- Better understand the selection of signal detection methodolies
- Have better insights of what methods would meet the needs for a given drug
- Have a better understanding of exectations and considerations of the health authorities in the signal detection process
Speaker(s)
Stéphane Bérard, MS
Regional Regulatory Compliance and Enforcement Specialist, Health Canada, Canada
Bruce Gordon, MSC
Senior Evaluator, Health Canada, Canada
Ruben Ayzin Rosoky, MD, PHD
Global Program Safety Lead, Novartis, France
Panel Discussion
, All Session Speakers, United States
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