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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)
Overview of Benefit-Risk Assessment in Medical Product Development: Context for Patient Engagement
Tarek Hammad, MD, PhD, MS, MSc, FISPE
Takeda, United States
Vice President, Head of Medical Safety, Marketed Products & Plasma-Derived Thera
Optimizing Canada’s Health Product Vigilance Approach: An Update
Rhonda Kropp, BSN, MPH
Health Canada , Canada
Director General, Marketed Health Products Division