Volver a Agenda
Session 4: Health Canada’s Review of the Draft Guidance on Annual Reporting and the Updated Guidance on ADR Reporting; Bill C-17 Updates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)
Anne Tomalin, RAC
, Tpireg, A Division of Innomar-Strategies Inc., Canada
Update on Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law)
Sarah Clayman
Regulator Project Manager, Health Products & Food Branch, Health Canada, Canada
Revised Canadian Guidelines for Adverse Reaction and Summary Reporting
Bruce Wozny, MA
Sr. Policy Officer, Health Products and Food Branch, Marketed Health Products, Health Canada, Canada
Co-Presenter
¿Tiene una cuenta?