This session will discuss The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) which aims to develop and validate innovative methods for benefit-risk (BR) assessment of medicine and describe the ongoing PROTECT study of signal detection in electronic health records,and in particular its development of strategies to strengthen or refute potential safety signals emerging from routine surveillance of longitudinal observational databases. We will also discuss the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) aimed at further strengthening post-authorization monitoring of medicines by facilitating the conduct of studies focusing on safety and on benefit-risk.