European Medicines Agency - ENCePP Information Day

Venue: De Vere Venues

Location: London, United Kingdom

Event Date/Time: Nov 26, 2010
Report as Spam


The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) is a project led by the European Medicines Agency (EMA) to bring together the available expertise and research experience in the fields of Pharmacoepidemiology and Pharmacovigilance scattered across Europe in a Network of Excellence, comprising research and medical-care centres, healthcare databases, electronic registries and existing networks. The number of centres collaborating with ENCePP has risen from 56 in 2007 to around 90 research organisations and data sources in 20 European countries and currently registered in a publicly accessible and fully searchable Resource Database.

The aim of the ENCePP project is to further strengthen the postauthorisation monitoring of medicinal products in Europe by facilitating the conduct of high quality, multicentre, independent postauthorisation studies focusing on safety and benefit risk. In order to achieve this ENCePP collaborating centres have developed, together with the EMA, the concept of an ENCePP study. Briefly, ENCePP studies are any pharmacoepidemiology or pharmacovigilance study carried out by an ENCePP collaborating centre that signs up to the following principles before the study commences:

An ENCePP Code of Conduct for scientific independence and transparency, which is essentially a set
of business rules between the study funder and the investigator
A checklist of methodological standards for study protocols
Registration of the study in the ENCePP electronic registry of pharmacoepidemiology and
pharmacovigilance studies before the study commences

The ENCePP Steering Group has recently been established. It includes representatives from the EMA,
the Committee for Medicinal Products for Human Use (CHMP), the PharmacoVigilance Working Party
(PhVWP), Heads of Medicines Agencies, Patients and Consumers Working Party, learned societies (ISPE
and ISoP) and ENCePP collaborating centres. They have recently adopted the ENCePP Code of Conduct
and the checklist of methodological research standards for study protocols following extensive public consultation.

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