Role of the Post-Marketing Authorisation Studies in Drug Risk Surveillance: Specifications and Methodologies

These safety studies, interventional or not, are related to a marketed drug, whether or not the drug is used within the market authorisation conditions. Apart from these safety studies, other studies whose primary objective is not risk assessment, including assessment of efficacy, description of prescription data and use in real life, pharmacokinetics, public health impact . . . can complete available safety data. The Giens Round Table examined PASS from the risk management plans of a sample of marketing authorisation holders (participants to the Round Table) and identified the main characteristics of proposed actions. Concerning the specifications and the choice of methodology, only a general outline has been sketched in view of the complexity and diversity of drug risks situations.