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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)
Understanding Challenges in Safety Reporting in Asia – The Emerging Regulatory Market: Comparison with US and EU
Mugdha Chopra, DDS
AWINSA Life Sciences, United States
Co-Founder and Director
Pre-Market Pharmacovigilance and its Challenges: Canadian Regulator’s Perspective
Hoda Eid, PhD, MSc
Health Canada, Canada
Manager, Office of Clinical Trials, Adverse Drug Reaction Division
Canadian Industry Perspective on Challenges Regarding ADR Reporting for Marketed Health Products
Caroline Croteau, PhD, RPh
Pfizer Canada Inc, Canada
Country Safety Lead