The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance: application to diabetes and vascular disease

Abstract

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) is an initiative led by the European Medicines Agency (EMA) aimed at further strengthening the post-authorisation monitoring of medicinal products in Europe by facilitating the undertaking of multi-centre, independent, studies focusing on safety and on benefit/risk. A key objective of ENCePP is to provide a unique point of access for all involved stakeholders, including industry or regulatory authorities, who are seeking collaboration for the commissioning or the performance of post-authorisation studies. The 2010 EMA regulatory action relating to rosiglitazone included a pharmacoepidemiological drug utilisation study to evaluate the benefit–risk profile in a real-life setting and has also led to the commissioning of an ENCePP study to evaluate the impact of risk-minimisation activities. ENCePP seeks to improve the European Union capacity to conduct such studies and thus support decision making. Application of the ENCePP study concept will result in an increase in trust in medicines and their use. In addition, the ENCePP register of studies will serve as a resource to allow for ready access to study protocols and results, thereby ensuring transparency.