Since the new EU pharmacovigilance legislation came into force in 2012, large volumes of data relating to post-authorization safety studies (PASSs) that drug companies conduct in Europe have become privately available. These data cover such things as regulatory methodological and operational considerations for post-approval studies. They provide a rich source of information for companies to consult when planning and designing a new PASS. This article reports on the first comprehensive review of three years of PASS protocols submitted to the European Medicines Agency.
Article August 17, 2016