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Approaches for Active Pharmacovigilance

October 2014

Dr. Donald M. Mattison
Senior Vice President and Chief Medical Officer
Risk Sciences International
Ottawa, ON, Canada


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Pharmacovigilance is a methodology used by many of the regulatory agencies to allow for improving patient safety through identifying, monitoring, and assessing the epidemiology of adverse health outcomes due to public consumption of medicinal products. This methodology allows for closing the knowledge gap regarding how drugs perform in real-life situations, when used by the different age groups, and where other comorbidities and risk factors come into play; which represent a group of important conditions that are not experienced and/or examined in the context of controlled clinical trials that precede the drugs’ approval and market entry phases. Pharmacovigilance aims eventually at preventing the incidence of, or mitigating the risks to the public due to use of such products, through providing useful information on the effectiveness, mechanisms of action, factors predisposing to the development of adverse outcomes, and the overall risk-benefit profiles of the different drugs.






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