The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) is a project led by the European Medicines Agency intended to further strengthen the postauthorisation monitoring of medicinal products in Europe by facilitating the conduct of multi-centre, independent, post-authorisation studies focusing on safety and on benefit:risk. This will be achieved by using available expertise and research experience in the fields of pharmacoepidemiology and pharmacovigilance across Europe in a network of excellence, comprising relevant research centres, medical-care centres, healthcare databases, electronic registries and existing European networks covering certain rare diseases, therapeutic fields and adverse drug events of interest.

This ambitious project started in 2006 and is a key initiative within the European Risk Management Strategy (ERMS), which aims to apply a proactive approach to monitoring of medicines throughout their lifecycle. The project will consist of several phases. The first phase, aimed at identifying a number of suitable centres across Europe, has been finalised. This has resulted in the establishment of a general inventory of over 80 research institutions following a survey at the level of EU Member States. In addition, an inventory of pharmacoepidemiological databases and useful patient registries is envisaged.
The current focus is on

• Establishing common research standards,
• Adopting a code of conduct to promote transparency and independence of any research undertaken by the network,
• Comprehensively cataloguing the available resources both in terms of research centres and of available data sources to perform the required research. A first version of the database of research resources was released in January 2010 and is currently being populated by the networks research centres. A second version including available data sources will be released in the second quarter of 2010.
• Establishing a publicly available electronic registry of studies where “ENCePP studies ” will have to be registered before they commence. The registry will also be open to non-ENCePP studies. The registry should be available in the third quarter of 2010.

Ultimately, stakeholders such as the pharmaceutical industry and regulatory agencies will be able to use this network of European resources to carry out the necessary studies in order to further characterise the benefit-risk balance of marketed medicines.

Thus, ENCePP will provide a unique opportunity to improve pharmacoepidemiological research and post-authorisation safety surveillance of medicinal products in Europe by offering access to a robust network of resources working in a transparent and independent manner according to the highest scientific standards.

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