Canadian Pharmacovigilance and Risk Management Conference

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Session 3: Canada Vigilance

Session Chair(s)

Marcia Bailey, BSN, MHS, RN

Safety Evaluation and Risk Management Scientific Director, GSK, Canada

Deborah Danoff, MD, FRCPC

Medical Evaluator, Health Canada, Canada

With many increasing health care and drug safety challenges, a good understanding of recent and evolving regulatory requirements and guidance will be important in maintaining patient safety in today’s climate. In this session, strategies in safety data collection, mandatory reporting, and in managing duplicate reports will be discussed.

Learning Objective : At the conclusion of this session, participants should be able to:
Understand updates related to the ICH E19 Guideline and its impact on Industry
Identify methods to help reduce duplicate reports in the Canada Vigilance Adverse Reaction Online Database
Describe important factors involved in the Implementation of Vanessa’s Law

Speaker(s)

Bernard Ogbiti, DrMed

Manager Medical Affairs, Methapharm Inc, Canada

Gayatri Jayaraman, PHD, MPH

Director, Marketed Health Products Directorate, Health Canada, Canada

Heidi Levens, MSC

Head of Canada, Patient Safety, Bristol-Myers Squibb Company, Canada

Fannie St-Gelais, PHD

Manager, Health Product and Food Branch, Health Canada, Canada

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