Joint Drug Information Association/European Medicines Agency information day on post-authorisation studies (PAS)
Location: European Medicines Agency, London, UK
This information day is targeted at industry, academia and contract research organisations (CROs). It will explore regulatory procedures, requirements and scientific guidelines on the conduct of both safety and efficacy studies, and explore the benefits of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) in supporting stakeholders in the conduct of PAS for regulatory decision making. This day will introduce new methodological guidance for pharmacoepidemiology studies investigating safety outcomes and regulatory guidance on post-authorisation efficacy studies. It will provide insight into current regulatory thinking about joint studies and how projects such as Accelerated development of vaccine benefit-risk collaboration in Europe (ADVANCE) and Pharmacoepidemiological research on outcomes of therapeutics by a European consortium (PROTECT) could enhance a lifecycle approach to product development and benefit risk management. Places limited.