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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)
Pharmacovigilance Challenges And Complexities in Medical Devices: US and EU Perspective
Sanjeev Miglani, MD
AWINSA Life Sciences, United States
Founder and Director
Canadian Perspective on the Challenges on Postmarket Surveillance for Medical Devices
Patrick Fandja, MBA, MS
Health Canada, Canada
Director, Bureau of Biologics, Radiopharmaceuticals and Self-care products
Postmarket Surveillance – Industry Perspective
Patrick Caines, PhD, MBA
Baxter Healthcare, United States
Senior Director, Quality & Compliance
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