In cooperation with RTI-Health Solutions, the BIPS in Bremen as well as the Klinikum Oldenburg and the Department of Medical Informatics at the UOL, we are currently conducting two studies on the indirect external validation of safety-relevant outcomes (target criteria).

Both studies were initiated in the context of conditional studies of the European Medicines Agency (EMA) as a result of an evaluation by the Pharmacovigilance Risk Assessment Committee (PRAC).