Pharmacoepidemiology and Pharmacovigilance. Synergistic Tools to Better Investigate Drug Safety

Table of Contents

1. Introduction 2. The role of pharmacoepidemiologic research in drug development 3. Pharmaco-epidemiology in the prevention of adverse drug reactions 4. Case Studies

Authors

Sabrina Nour Pre-Market Scientific Evaluator and Epidemiologist, Health Canada, Montreal, Canada. Sabrina Nour is a Clinical Evaluator and Epidemiologist where she is in charge of reviewing the efficacy and safety of biological products. She holds a Master's degree in epidemiology and a certificate in population risk evaluation and health management. Sabrina has acquired more than 6 years of experience working on drug safety and pharmacovigilance, including pharmacoepidemiology. Her major interests lie in pharmacoepidemiology methodology, pharmacovigilance activities, and in the influence of health policies on populations. Gilles Plourde Senior Clinic Evaluator for Health Canada's regulatory agency; Associate Professor, Department of Clinical Pharmacology and Physiology, University of Montreal, Canada and Associate Professor, School of Physical Activity Science, University of Ottawa, Canada. Dr. Plourde is a senior clinic evaluator for the Health Canada's regulatory agency. He is an associate professor in the department of clinical pharmacology and physiology, Faculty of Medicine at the University of Montreal and at the school of physical activity sciences, Faculty of Health Sciences at the University of Ottawa. He holds a doctorate in medicine (MD) from the University of Montreal and a PhD in experimental medicine from Laval University. His studies led him to publish several articles in highly rated peer-reviewed journals and to make numerous presentations for prestigious national and international associations. He has more than 12 years' experience working on drug safety, especially for biologic products involved in the treatment of various cancers. He has also supervised many students and employees interested in the prevention of the adverse effects of health products both in clinical research and/or when health products have obtained marketing authorization.