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Session 3A: Postmarket Pharmacovigilance
Session Chair(s)
Marc Poitras, PHD, MBA
Scientific Manager, Marketed Pharmaceuticals and Medical Devices Bureau, Health Canada, Canada
Adverse Drug Reactions (ADR) reporting is one of the cornerstones of pharmacovigilance. Harmonization of ADR reporting practices nationally and internationally brings its own challenges. Listen in as representatives from Health Canada and the Industry discuss the challenges associated with ADR reporting in Canada and abroad. You will learn the similarities and differences between different ADR reporting regulations in Canada, US, EU, and Asia, and their impact on the ability to monitor drug safety.
Speaker(s)
Mugdha Chopra, DDS
Co-Founder and Director, AWINSA Life Sciences, United States
Understanding Challenges in Safety Reporting in Asia – The Emerging Regulatory Market: Comparison with US and EU
Hoda Eid, PHD, MSC
Manager, Office of Clinical Trials, Adverse Drug Reaction Division, Health Canada, Canada
Pre-Market Pharmacovigilance and its Challenges: Canadian Regulator’s Perspective
Caroline Croteau, PHD, RPH
Country Safety Lead, Pfizer Canada Inc, Canada
Canadian Industry Perspective on Challenges Regarding ADR Reporting for Marketed Health Products