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Virtual Event

Oct 21, 2020 10:25 AM - Oct 22, 2020 4:15 PM

(US Eastern Standard Time)

Fort Washington, PA 19034

Canadian Pharmacovigilance and Risk Management Conference

Session 6: Signal Detection

Session Chair(s)

Bruce  Valliant

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

Health Canada Perspective on Selection of Signal Detection Process

Stéphane Bérard, MS

Health Canada, Canada

Regional Regulatory Compliance and Enforcement Specialist

Bruce  Gordon, MSc

Speaker

Bruce Gordon, MSc

Health Canada, Canada

Senior Evaluator

Ruben  Ayzin Rosoky, MD, PhD

Industry Considerations, Limitations Affecting Choices for Signal Detection

Ruben Ayzin Rosoky, MD, PhD

Novartis, France

Global Program Safety Lead

Panel  Discussion

Panel Discussion

All Session Speakers, United States

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