Coordinated by the European Medicines Agency, the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) project was launched to strengthen the monitoring of the benefit-risk of medical products in Europe. A methodological framework for the project is currently being developed through public and private partnerships. This framework focuses on data collection and the early detection and assessment of adverse events. Dr. Xavier Kurz, Principal Scientific Administrator at the Post-Authorisation, Pharmacovigilance, and Risk Management Sector of the European Medicines Agency, provided an overview of this project. Dr. Kurz discussed PROTECT’s governance, innovative tools, methods that are currently being or have recently been developed, and the project’s future direction.