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What is ENCePP?

See also: ENCePP Q&A

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP®) is a collaborative scientific network coordinated by the European Medicines Agency and developed in collaboration with European experts in the fields of pharmacoepidemiology and pharmacovigilance. Its goal is 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, using available expertise and research experience across Europe. This network of excellence comprises 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.

ENCePP provides 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. This can be done either by contacting directly the individual centres and networks that are registered in ENCePP or by submitting a request to the ENCePP Secretariat to place a third party announcement in the ENCePP partners forum.

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. This resulted in the establishment of a general inventory of research institutions following a survey at the level of EU Member States.

Early 2010 saw the launch of the ENCePP Database of Research Resources which is a public, fully searchable electronic index of the available EU research resources in the field of pharmacoepidemiology and pharmacovigilance. The research database has two components, the Inventory of ENCePP research centres and networks, and the Registry of EU data sources. The resources database is complemented by one of the network's most ambitious projects to date, the E-Register of Studies which was released in November 2010. The E-Register provides a publicly accessible resource for the registration of pharmacoepidemiological and pharmacovigilance studies.

A further milestone was achieved with the adoption by the ENCePP Steering Group in May 2010 of the 'ENCePP Code of Conduct'. The Code of Conduct provides a set of rules and principles for pharmacoepidemiology and pharmacovigilance studies as regards best practice and transparency, thereby promoting scientific independence of such studies. In parallel, the 'Checklist of Methodological Standards for ENCePP Study Protocols' (now named the 'ENCePP Checklist for Study Protocols') was developed to stimulate researchers to consider important epidemiological principles when designing a pharmacoepidemiological study and writing a study protocol, to promote transparency regarding methodologies and design used in pharmacoepidemiological studies performed in the EU, and to increase awareness about developments in science and methodology in the field of pharmacoepidemiology.

Building on the initial phase of establishment, during 2011 and 2012 the priority will be to consolidate ENCePP as an important and internationally renowned resource in the field of pharmacovigilance and pharmacoepidemiology that delivers for health protection and promotion. For more information, please see the current ENCePP work plan.

ENCePP organisational structure

The working model of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance consists of the following elements:

Central to ENCePP is a comprehensive database of research resources comprising EU research centres and networks with expertise in Pharmacoepidemiology & Pharmacovigilance and pertinent databases, registries and other relevant data sources. The ENCePP Plenary is the meeting of representatives from registered research centres and networks/collaborations. The mandate, objectives and rules of procedure for the ENCePP Plenary are available here.

The European Medicines Agency was initially supported by the ENCePP Implementation Advisory Group, which provided advice on the establishment and promotion of the network during its tenure from March 2008 until December 2009. In January 2010 this interim advisory group was replaced by a permanent ENCePP Steering Group, which will oversee the mid- to long-term implementation of the project. In order to support the operational and administrative work of the Steering Group, an ENCePP Secretariat has been established by the European Medicines Agency.

A number of working groups and task forces have been established to develop pivotal aspects of the network. These groups will be of a temporary nature and the Agency and Steering Group will decide on a case-by-case basis about their tenure. The Steering Group may establish additional working groups and refer to them any matter in the Steering Group’s mandate.