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Session 5, Track C: Health Canada Pharmacovigilance Updates
Session Chair(s)
Yulia Vasianovich, PhD, RAC
Scientific Evaluator, Marketed Health Products Directorate
Health Canada, Canada
Daniel Greco, PharmD, MS, RPh
Associate Director of Patient Safety
Bristol-Myers Squibb Company, Canada
This session will highlight key initiatives transforming post-market safety evaluation in Canada. We will begin with the Health Canada’s Operation Glasswing, an activity aimed at exploring a long-standing concern raised by industry with obtaining meaningful AR data from the Canada Vigilance Program. Health Canada will also provide an overview of the WHO pharmacovigilance tools such as VigiLyze database, the global platform from the Uppsala Monitoring Centre, which enables review of aggregated AR reports across countries, and providing valuable international context for Health Canada's pharmacovigilance activities.
- Operation Glasswing: Understanding Barriers to Adverse Reaction Data Access for Industry
Laura Muranyi, Health Canada - Health Canada’s Overview and Use of WHO/UMC Pharmacovigilance Tools
Da Graça, Health Canada
Learning Objective :
At the conclusion of this session, participants should be able to:
- Describe industry barriers to accessing the Canada Vigilance adverse reaction (AR) data
- • Explain how continued collaboration with the World Health Organization (WHO) supports Health Canada pharmacovigilance activities
Speaker(s)
Health Canada’s Overview and Use of WHO/UMC Pharmacovigilance Tools
Silas Da Graça, MSc
Health Canada, Canada
A/Manager, Adverse Reaction Monitoring and Information Section
Operation Glasswing: Understanding Barriers to Adverse Reaction Data Access for Industry
Laura Muranyi
Health Canada, Canada
Manager, Health Products Surveillance and Epidemiology Bureau
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