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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)
Canada Vigilance Database Duplicate Cases – Industry Challenges
Bernard Ogbiti, DrMed
Methapharm Inc, Canada
Manager Medical Affairs
Assuring Complete and Accurate Adverse Reaction Reporting-Moving from Good to Best
Gayatri Jayaraman, PhD, MPH
Health Canada, Canada
Director, Marketed Health Products Directorate
ICH E19 Guideline – An Industry Perspective
Heidi Levens, MSc
Bristol-Myers Squibb Company, Canada
Head of Canada, Patient Safety
ICH E19 Guideline Updates
Fannie St-Gelais, PhD
Health Canada, Canada
Manager, Health Product and Food Branch
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