概要
Tutorial: May 20, 2015
Meeting: May 21, 2015
This 1-day meeting will provide new insights into the current issues and associated challenges impacting drug safety in Canada. Expert pharmaceutical, biotechnology, and regulatory thought leaders will discuss Regulatory Guidance Document Updates, the impact of Bill C-17 on adverse drug reaction reporting, Pharmacovigilance (PV) Agreements, eReporting, special product areas; and much more.
Session topics to include:
- ADR Reporting Guidance
- Annual Summary Reporting Guidance
- Risk Management Guidance
- Benefit-Risk Assessment Guidance
- Q&A with Inspectorate
- Industry Perspective on Medical Devices and Combination Products
- Generics
- OTCs and Natural Health Products
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プログラム委員会
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Marcia Bailey, BSN, MHS, RN Safety Evaluation and Risk Management Scientific Director
GSK, Canada -
Rita Cassola, RPH Executive Director PV
Certus PV Services Inc, Canada -
Rebecca Noel, DrPH, MPH Executive Director, Benefit-Risk Assessment
Eli Lilly, United States -
Marc Poitras, PHD, MBA Scientific Manager, Marketed Pharmaceuticals and Medical Devices Bureau
Health Canada, Canada
