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Session 3 Track 1 - New Frontiers: Harmonizing in the Post-Approval Pharmacovigilance: Challenges and Opportunities
Session Chair(s)
Vratislav Hadrava, MD, PhD
Vice President and Medical Director, Global Innovative Products
Pfizer Canada, Inc., Canada
Pharmacovigilance is a rapidly evolving and increasingly global field. Government and Industry are often criticised for taking action in one jurisdiction not always harmonised to action in another. With the near instantaneous dissemination of information and the different global regulatory practices with respect to risk management, the regulators and the pharmaceutical industry are faced with challenges in trying to find the best way to manage risk while at the same time meeting expectations from various stakeholders. This session will provide the perspective of Health Canada, Industry and other stakeholders to provide understanding and appreciation of the current practices, consumers’ expectations, challenges and opportunities for change. The expectations of global harmonisation will also be explored.
Speaker(s)
Challenges and Opportunities in Post Market Pharmacovigilance: A Canadian Perspective
Melissa Hunt, MSc
Health Canada, Canada
Director
Presenter
Dianne Azzarello
Celgene Inc., Canada
Director, Pharmacovigilance and Regulatory
Harmonizing in the Post-Approval Pharmacovigilance: Challenges and Opportunities
Yola Moride, PhD, FISPE
YolaRX Consultants, Canada
President