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Session 1: What’s New and What’s Hot in Pharmacovigilance
Session Chair(s)
Marc Poitras, PhD, MBA
Scientific Manager, Marketed Pharmaceuticals and Medical Devices Bureau
Health Canada, Canada
In this session, you will learn about new/ongoing initiatives to strengthen postmarket surveillance activities. Representatives from Regulatory Agencies and industry will describe and discuss the progress of the implementation and the challenges anticipated and encountered. You will learn, among other things, how leveraging pharmacovigilance databases could facilitate the detection, assessment and confirmation of safety signals.
Speaker(s)
Modernizing Pharmacovigilance in Canada
Melissa Hunt, MSc
Health Canada, Canada
Director
Real World Evidence: How Can We Use It Effectively to Inform Decision-Making
Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
Consultant, United Kingdom
Strategy
New Developments in Postmarketing Drug Safety
Gerald Dal Pan, MD, MHS
FDA, United States
Director, Office of Surveillance and Epidemiology, CDER
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