The ENCePP working groups are of a temporary nature in line with the continued development of the network and the objectives and deliverables of the network’s work plans. The European Medicines Agency together with the ENCePP Steering Group may therefore decide on a case-by-case basis about their tenure and composition. New working groups may also be established as appropriate.
Working Group 1 - ENCePP research standards and guidances
Updated mandate is coming in 2024
Mandate: To address methodological aspects of the generation of evidence-based information supporting the needs of regulatory and HTA decision-making
Chair: Alejandro Arana
- Identify areas in which research standards and guidances relevant for ENCePP activities are needed and identify or develop such guidance.
- Periodically review the ENCePP Checklist for Study Protocols. • Periodically review the Guide on Methodological Standards in Pharmacoepidemiology.
- Monitor the development of accreditation systems and their methodologies.
- Support training relevant to the ENCePP standards.
- Support the implementation of new and existing standards.
Working Group 2 - Independence and transparency
Updated mandate is coming in 2024, reflecting the migration of the EU PAS Register and the ENCePP Resource Database
Chair: Rosa Gini
Code of Conduct:
- Assess the need to supplement the Code of Conduct with additional tools to support good governance of pharmacoepidemiological research.
- Further elaborate some of the provisions already included in the Code of Conduct, e.g. by developing specific guidance, policies or sample/template contracts.
- Explore ways to better monitor implementation of the Code of Conduct for ENCePP Seal studies.
- Support the use of the Code of Conduct.
- Support registration of studies in the EU PAS Register.
EU PAS Register and ENCePP databases:
- Support EMA in the further development of the EU PAS Register and ENCePP databases.
- Provide recommendations for business requirements to ENCePP Steering Group and EMA.
Working Group 3 - Inventory of EU data sources and methodological approaches for multi-source studies
Updated mandate is coming in 2024, reflecting the migration of the EU PAS Register and the ENCePP Resource Database
Chair: Gianluca Trifiro
- Promote the registration of data sources useful for pharmacoepidemiology and pharmacovigilance research in the already existing ENCePP Resources database and encourage regular update
- Publish an overview of available EU databases relevant for pharmacovigilance and pharmacoepidemiology research
- Perform an analysis of regulatory needs to evaluate the extent to which the existing data sources are able to meet them
- Facilitate the initiation and conduct of observational research through the ENCePP network; develop guidance on conceptual models for multi-national and multi-database studies
- Assess the impact of forthcoming clinical trials and data protection legislation on ENCePP activities and provide expert input during implementation