The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP®) is a network coordinated by the European Medicines Agency (EMA). The members of this network (the ENCePP partners) are public institutions and private companies such as contract research organisations (CROs) involved in research in pharmacoepidemiology and pharmacovigilance. Research interests include disease epidemiology, drug utilisation, and assessing the benefits (effectiveness) and risks (safety) of medicines. ENCePP partners are registered in the HMA-EMA Catalogues under institutions or networks. Participation to ENCePP is voluntary.
Scope
ENCePP aims to strengthen the monitoring of the benefit-risk balance of medicinal products in Europe by:
- Bringing together capacity and expertise in pharmacoepidemiology and pharmacovigilance across Europe and providing a platform for collaborations;
- Facilitating the conduct of high-quality, multi-centre, independent non-interventional studies (NIS);
- Developing and maintaining methodological standards and governance principles for research in pharmacovigilance and pharmacoepidemiology;
- Providing a network of excellence in pharmacoepidemiology that can be leveraged in public health emergencies.
ENCePP provides a unique opportunity for collaboration to improve pharmacoepidemiological research and benefit-risk assessment of medicinal products in Europe through access to a network of resources working in a transparent and independent manner, and to support to the conduct of non-interventional studies.
While ENCePP provides guidance on methods and governance principles aiming at improving the conduct of non-interventional studies to support regulatory decision-making, ENCePP does not provide a forum for regulating medicinal products nor for assessing their benefits and risks.
Key outputs
Since its establishment ENCePP has produced several key outputs:
- The former ENCePP Resources Database. Information on data sources, institutions and networks are now available in the HMA-EMA Catalogues of real-world data sources;
- The former EU PAS Register. Registration of, and search for studies are now available in the HMA-EMA Catalogues of real-world data studies;
- The ENCePP Guide on Methodological Standards in Pharmacoepidemiology: a resource for methodological guidance in pharmacoepidemiology;
- The ENCePP Code of Conduct: a set of rules and principles for pharmacoepidemiology and pharmacovigilance studies to promote transparency and scientific independence throughout the research process;
- The ENCePP Checklist for Study Protocols: a tool to promote the quality of studies through study design;
- Support to public health emergencies (e.g., during the COVID-19 pandemic through methods and selection of suitable data sources, and recommendations for registration of studies);
- Publications in peer-reviewed journals and reference in regulatory and non-regulatory guidelines and scientific publications;
- Contribution of the ENCePP community to multiple research projects and guideline developing activities (e.g., ICH).