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Session 5: Canada Vigilance Updates
Session Chair(s)
Mélanie Derry, PhD
Associate Director
Health Canada, Canada
The Canada Vigilance database has been evolving at a rapid rate over the past few years. With the advent of mandatory reporting of adverse drug reactions (ADRs) by hospitals, Canada Vigilance and its partners face new opportunities and challenges in data collection and analysis. This session will describe new developments in Health Canada and industry perspectives on expanding and improving Canada Vigilance’s capacities.
Learning Objective : At the conclusion of this session, participants should be able to:- Identify ADR reporting regulatory requirements and related topical issues
- Discuss new improvements to the Canada Vigilance database from an information management/technology perspective
- Describe challenges faced by industry partners in meeting ADR reporting regulatory requirements
Speaker(s)
Reporting Adverse Reactions from Various Sources: Regulatory Requirements and Submission Process
Paul Litowitz, MBA, RAC
Health Canada, Canada
Manager, Public and Regulatory Affairs Outreach Section
Adverse Reaction Reporting: Industry Challenges
Gautamdeep Kaur
Certus PV Services, Canada
Pharmacovigilance and Medical information Manager
Speaker
Laura Meaney
Health Canada, Canada
Manager, Health Products Surveillance and Epidemiology Bureau