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Lecture in “Pharmacovigilance in Canada: Continuous improvement to post-market surveillance and drug safety and effectiveness
February 2010

Vicky Hogan, MSc, PhD.
Director, Office of Risk Management
and Science Marketed Health Product Directorate, Health Canada
Tel: (613) 957-0336



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This presentation entitled Pharmacovigilance in Canada: continuous improvement to post-market surveillance and drug safety and effectiveness summarized the key post-market surveillance program activities undertaken by Health Canada to ensure that health products sold in Canada remain safe and effective. Pharmacovigilance is a science based on hypothesis generation, and it seeks to detect and identify signals or potential problems with pharmaceutical and health products, which can subsequently be assessed using traditional and novel pharmacoepidemiological methods. The World Health Organization (WHO) defines pharmacovigilance as “The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems”. The key challenges of Health Canada’s Post-Market Surveillance Program are also described along with health product risk communication tools such as MedEffectTM Canada. Adverse Reaction (AR) cases and challenges in interpreting AR data are discussed.



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