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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, MS
Risk Management Lead, Sanofi Canada, 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.
Updates – Implementation of Agile RMP Regulations and Guidance Marie-Thérèse Bawolak, Health Canada
Annual Summary Reports (ASRs) and Notifications of Significant Change (NSC) under the Food and Drug Regulations Bruce Gordon, Health Canada
Overview of the NFA Process Aws Abdul-Wahid, Health Canada
Vicki Sabourin, Health Canada
Learning Objective : At the conclusion of this session, participants should be able to: - Identify updates to Health Canada’s NFA, Summary Reporting, and RMP guidances and their implications for PV and regulatory processes
- Outline practical approaches to integrate evolving regulatory expectations into PV systems and workflows
- Discuss lifecycle risk management strategies, including implementation of Agile RMP requirements
Speaker(s)
Annual Summary Reports (ASRs) and Notifications of Significant Change (NSC) under the Food and Drug Regulations
Bruce Gordon, MSc
Senior Evaluator, Health Canada, Canada
Overview of the NFA Process
Aws Abdul-Wahid, PhD
Scientific Evaluator, Health Canada, Canada
Updates – Implementation of Agile RMP Regulations and Guidance
Marie-Therese Bawolak, PhD, MSc
Manager, Bureau of Biologics, Radiopharmaceuticals and Self-Care Products, Health Canada, Canada
Speaker
Vicki Sabourin, BSN, MSc
Acting Team Lead, Marketed Health Products Directorate, Health Canada, Canada
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