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Session 6C: Postmarket Considerations: Including PV Inspections, Global Drug and Device Challenges, and Vanessa’s Law
Session Chair(s)
Lorella Garofalo, PHD
Head of Regulatory Sciences, Pfizer Canada ULC, Canada
Amendments to the Canadian Food and Drugs Act under Bill C-17 have resulted in a broadening of Health Canada’s (HC) powers in particular concerning the collection of post-market safety information. This session will provide an overview of the ongoing modernization and renewal efforts being undertaken by Health Canada on its Good Pharmacovigilance Program (GVP) inspection program and in addition discuss recent trends in GVP inspections. An update by HC on Bill C-17 related regulations and the Industry perspective on the impact, benefit and cost of implementing Bill C-17 requirements based on current proposals will also be presented.
Speaker(s)
Sophie Lafrance
Corporate Regulatory Compliance & Enforcement Advisor, Health Canada, Canada
Updates on the Good Pharmacovigilance Practices Inspections
Rocelyn DelCarmen
Director, Regulatory Affairs and Quality Assurance, Astrazeneca Canada Inc., Canada
Vanessa's Law - Costs and Benefits of Implementation
Debra Haltrecht
, Health Canada, Canada
Vanessa’s Law – Update on Implementation
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