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Session 3C: Pharmacovigilance for Medical Devices – A Global Perspective
Session Chair(s)
Maggie Graham
Senior Policy Analyst, Natural and Non-Prescription Health Products Directorate, Health Canada, Canada
Over time, there is a progression in the knowledge about a health product. Regulators are using this knowledge to inform postmarket work that considers the full life cycle of a health product. This session will take a closer look at medical devices and discuss the strategies for postmarket surveillance on an international level.
Speaker(s)
Sanjeev Miglani, MD
Founder and Director, AWINSA Life Sciences, United States
Pharmacovigilance Challenges And Complexities in Medical Devices: US and EU Perspective
Patrick Fandja, MBA, MS
Director, Bureau of Biologics, Radiopharmaceuticals and Self-care products, Health Canada, Canada
Canadian Perspective on the Challenges on Postmarket Surveillance for Medical Devices
Patrick Caines, PHD, MBA
Senior Director, Quality & Compliance, Baxter Healthcare, United States
Postmarket Surveillance – Industry Perspective