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Welcome, Opening Remarks and Session 1: Pharmacovigilance and Risk Management during the Pandemic: Perspective from the Regulators
Session Chair(s)
Marc Poitras, PHD, MBA
Scientific Manager, Marketed Pharmaceuticals and Medical Devices Bureau, Health Canada, Canada
The global pandemic has forced public health and regulatory authorities worldwide to adapt rapidly to deal with the evolving situation. In this session, representatives from regulatory agencies (EMA, FDA and Health Canada) will discuss how they have revised their pharmacovigilance and risk management practices while ensuring the safe use of therapeutic health products.
Learning Objective : At the conclusion of this session, participants should be able to:
- Gain a Global Understanding of the Regional Changes Made to Current PV/RM Practices in Order to Deal with the Pandemic
Speaker(s)
Georgy Genov, MD
Head of Pharmacovigilance Office, European Medicines Agency, Netherlands
Gerald Dal Pan, MD, MHS
Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Kelly Robinson, MSC
Director General, Pharmaceutical Drugs Directorate, Health Canada, Canada
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