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Session 4: Health Canada’s Review of the Draft Guidance on Annual Reporting and the Updated Guidance on ADR Reporting; Bill C-17 Updates
Session Chair(s)
Marcia Bailey, BSN, MHS, RN
Safety Evaluation and Risk Management Scientific Director
GSK, Canada
During this session, Health Canada will review two guidance documents. Updates to Bill C-17 (Vanessa’s Law) will be discussed. Topics addressed will include an overview of the new recall powers of Health Canada, how life science companies can ensure their current process for reporting to regulatory authorities is updated to meet the new requirements, a description of new reporting requirements for companies, and a review of the implementation timeline.
Speaker(s)
Update on Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law)
Anne Tomalin, RAC
Tpireg, A Division of Innomar-Strategies Inc., Canada
Revised Canadian Guidelines for Adverse Reaction and Summary Reporting
Sarah Clayman
Health Canada, Canada
Regulator Project Manager, Health Products & Food Branch
Co-Presenter
Bruce Wozny, MA
Health Canada, Canada
Sr. Policy Officer, Health Products and Food Branch, Marketed Health Products
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