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Ottawa Marriott Hotel

16 oct 2017 7:00 a.m. - 16 oct 2017 5:00 p.m.

100 Kent Street , Ottawa, ON K1P5R7 , CANADA

Canadian Pharmacovigilance and Risk Management Strategies Conference

Session 4: Health Canada’s Review of the Draft Guidance on Annual Reporting and the Updated Guidance on ADR Reporting; Bill C-17 Updates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

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

Update on Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law)

Anne Tomalin, RAC

Tpireg, A Division of Innomar-Strategies Inc., Canada

Sarah  Clayman

Revised Canadian Guidelines for Adverse Reaction and Summary Reporting

Sarah Clayman

Health Canada, Canada

Regulator Project Manager, Health Products & Food Branch

Bruce  Wozny, MA

Co-Presenter

Bruce Wozny, MA

Health Canada, Canada

Sr. Policy Officer, Health Products and Food Branch, Marketed Health Products

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