The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) is a network of over 170 research centres, existing networks and providers of healthcare data, which is coordinated by the European Medicines Agency. Its goal is to strengthen post-authorisation monitoring of medicines by facilitating the conduct of multicentre, independent studies focusing on safety and on the balance of benefits and risks, using available European research expertise.
ENCePP is a key element in generating robust evidence to support regulatory decision-making for the benefit of public health.
ENCePP has been instrumental in developing the principles and best practice for the conduct of post-authorisation safety studies (PASSs) from inception, contract signature and protocol drafting, through to the reporting of results. This is reflected in the guideline on good pharmacovigilance practices: module VIII - PASSs.
ENCePP was established in line with the pharmaceutical legislation and the road map to 2010.
ENCePP complements the existing tools of the European Union's pharmacovigilance system, such as risk-management plans and EudraVigilance.
- European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
- Good pharmacovigilance practices