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Session 1: What’s New and What’s Hot: Perspective on Pharmacovigilance and Risk Management
Session Chair(s)
Marc Poitras, PHD, MBA
Scientific Manager, Marketed Pharmaceuticals and Medical Devices Bureau, Health Canada, Canada
In this session, representatives from regulatory agencies and the industry will discuss the progress of the implementation of new/ongoing national, international initiatives to strengthen pharmacovigilance and risk management activities.
Speaker(s)
Tarek Hammad, MD, PHD, MS, MSC, FISPE
Vice President, Global Head of Medical Safety, Marketed Products and PDT, PSPV, Takeda Pharmaceuticals, United States
Overview of Benefit-Risk Assessment in Medical Product Development: Context for Patient Engagement
Rhonda Kropp, BSN, MPH
Director General, Marketed Health Products Division, Health Canada , Canada
Optimizing Canada’s Health Product Vigilance Approach: An Update