Coordinated by the European Medicines Agency (EMA), the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) brings together expertise and resources in pharmacoepidemiology and pharmacovigilance across Europe.
ENCePP aims to strengthen the monitoring of the benefit-risk balance of medicines, primarily by facilitating the conduct of high quality, multi-centre, independent post-authorisation studies (PAS) with a focus on observational research.
EMA set up the network in 2007. It consists of public institutions and contract and research organisations, working in collaboration with the European medicines regulatory network. Participation in ENCePP is voluntary.
Post-authorisation safety studies
ENCePP played a key role in developing the principles and best practices for the planning, design, conduct and reporting of post-authorisation safety studies (PASS). These are referenced in the good pharmacovigilance practices (GVP) guideline on PASS:
EU PAS Register
The ENCePP website hosts the European Union electronic register of post-authorisation studies (EU PAS Register), which contains public information on non-interventional post-authorisation studies (PAS). The register aims to increase transparency and reduce publication bias.
The EU pharmacovigilance legislation requires EMA to publish the protocols and abstracts of results of imposed non-interventional PASS in this register.
Marketing authorisation holders should also submit information for publication in the EU PAS Register on:
- any PASS initiated, managed or financed voluntarily by the marketing authorisation holder;
- any PASS required in a risk management plan, in line with GVP Module VIII;
- post-authorisation efficacy studies that are not clinical trials;
- any other PAS.
EMA coordinates ENCePP's activities and further development of the network. The ENCePP steering group oversees the implementation of the network's work plans.
EMA provides the ENCePP secretariat, which facilitates the work of the ENCePP steering group and supports the communication and information flow between ENCePP partners, stakeholders and any other interested party.
Collaboration of the network on specific objectives and activities is organised through working groups and special interest groups in line with EMA’s multi-annual work programme.
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