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Session 5, Track C: Advance Pharmacovigilance Inspection Readiness: From Health Canada GVP Insights to Global Compliance
Session Chair(s)
Ricardo Pasquel Cook, MD
Safety Team Lead, Pfizer Inc., Canada
Liliana Di Stabile, MD
Safety Physician, Knight Therapeutics Inc., Canada
This session explores the practical implications of Health Canada’s evolving GVP expectations with a focus on inspection readiness and compliance for pharmacovigilance organizations. Anchored in the Canadian context, the discussion will provide an overview of the Health Canada GVP inspection process, key pharmacovigilance inspection metrics and trends, common inspection findings, and recurring global deficiencies that can impact local compliance. Participants will also examine case studies, lessons learned, and recommended corrective and preventive actions (CAPAs), while exploring ways to streamline inspection preparedness across jurisdictions, including coordinated or joint Health Authority inspections. The session will also incorporate an industry perspective on inspection readiness, including practical experience from dual inspections and comparisons with other foreign inspection approaches. Attendees will leave with actionable strategies to strengthen readiness, reduce friction during inspections, and support efficient cross-border compliance.
Learning Objective : At the conclusion of this session, participants should be able to: - Describe the Health Canada GVP inspection process, including key pharmacovigilance inspection metrics and trends
- Identify common inspection findings and recurring global deficiencies that can affect local compliance
- Apply lessons learned from regulatory and industry perspective, including CAPA-focused strategies, to strengthen inspection readiness across jurisdictions
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