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Session 8, Track C: Vanessa's Law: Impact and Challenges of Mandatory Adverse Reaction Reporting
Session Chair(s)
Marcia Bailey, BSN, MHS, RN
Safety Evaluation and Risk Management Scientific Director, GSK, Canada
Vanessa Zapata
Associate Director, Regional Pharmacovigilance Officer, Merck Canada Inc., Canada
Vanessa’s Law (Bill C-17) became effective in 2014. This session provides an overview of Health Canada’s perspective and expectations regarding implementation of the law and its impact on health care facilities. This session will also include challenges that the pharmaceutical industry is currently facing.
Learning Objective : At the conclusion of this session, participants should be able to:- Explain Health Canada’s expectation regarding the implementation of Vanessa’s Law
- Identify the actions required by health care facilities to be compliant with Vanessa’s Law
- Describe challenges faced by the Industry following the implementation of Vanessa’s Law
Speaker(s)
Aurela Balla, DrMed
Senior Director, Pharmacovigilance, Merck Canada Inc., Canada
Vanessa's Law: Impact and Challenges of Mandatory Adverse Reaction Reporting, from an Industry Perspective
Marie-Claude Brutus Lopez, RPH
Coordinator, Canada Vigilance Program, Marketed Health Products Directorate, Health Canada, Canada
Health Canada Refresher: Mandatory Reporting of Medical Device Incidents (MDIs) and Serious Adverse Drug Reactions (ADRs) by Hospitals
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