Description
Drug safety monitoring and risk management are vitally important for medicinal product developers, license holders and clinical investigators. In addition to their duty to protect public health, increasingly tight regulation and potentially massive payments to litigants provide strong incentives for pharmaceutical and biotechnology companies to ensure that they maintain efficient systems for drug safety and good pharmacovigilance practice (GVP), so that all staff are aware of the basic requirements.
This course will provide students with an overview of the most important aspects of this discipline, both before and after marketing of products, especially as they apply in Europe and the USA.
