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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 safety studies and studies focusing on lack of efficacy. 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 focus for 2008-2009 is on
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.
