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Session 4, Track C: Translate Policy into Practice: Applying Health Canada's 2026 Pharmacovigilance Guidance
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 explore how evolving regulatory expectations can be translated into practical, operational strategies for industry stakeholders. Health Canada will provide an overview of updates to the guidances related to Notice of Foreign Actions (NFA) and Annual Summary Reports (ASR), highlighting key requirements and considerations for implementation. The session will also touch on selected elements of the guidance covering Risk Management Plan (RMP), offering perspectives on implementation of Agile RMP regulations.
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