PROTECT project - The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium

The Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium is a collaborative European project that comprises a programme to address limitations of current methods in the field of pharmacoepidemiology and pharmacovigilance. EMA is the coordinator of PROTECT and GSK is the deputy co-ordinator of PROTECT. They manage a multi-national consortium of 34 partners including academics, regulators, SMEs and EFPIA companies. The goal of PROTECT is to strengthen the monitoring of the benefit-risk of medicines in Europe. This will be achieved by developing a set of innovative tools and methods that will enhance the early detection and assessment of adverse drug reactions from different data sources, and enable the integration and presentation of data on benefits and risks. These methods will be tested in real-life situations in order to provide all stakeholders (patients, prescribers, public health authorities, regulators and pharmaceutical companies) with accurate and useful information supporting risk management and continuous benefit-risk assessment.