PROTECT

PROTECT is a public-private European project funded by the Innovative Medicines Initiative Joint Undertaking. It comprises a 5 year research programme to address limitations of current methods in the field of pharmacoepidemiology and pharmacovigilance. The European Medicines Agency is the coordinator and Glaxo Smith Kline is the deputy coordinator of this multi-national consortium of 31 partners. The goal 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 to improve the early detection of safety signals,enhance direct data collection from consumers and provide for a continous benefit/risk monitoring of medicines. In addition,a methodological framework of pharmacoepidemiology studies will be developed aiming at increasing the usefulness and reliability of these studies for benefit/risk assessment. All methods will be tested to demonstrate their usefulness and applicability.