Terms of reference
Scope
- The aim of the ENCePP Working Groups (WGs) and Special Interest Groups (SIGs) is to address the objectives and deliverables of the ENCePP workplan.
- The WGs and SIGs are of a temporary nature, in line with the continued development of the ENCePP network and the changing environment in the field of pharmacoepidemiology and pharmacovigilance.
- Each WG or SIG has a mandate, defined by the chairs and members, and reflected in clearly outlined objectives and deliverables, with specified timelines
- For both WGs and SIGs, the mandate along with the planned activities are endorsed by the Steering Group.
Closed WGs
Working Group 1 - ENCePP research standards and guidances
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
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.
‘Conduct your study’ podcast series
In this podcast series, various topics will be addressed, such as conflicts of interest of researchers, transparency, and scientific independence when conducting non-interventional post-authorisation studies. A wide range of stakeholders will feature in the episodes including study investigators, regulators, researchers employed by pharmaceutical companies, clinicians, and patients.
Working Group 3 - Inventory of EU data sources and methodological approaches for multi-source studies
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
Closed SIGs
SIG on Drug Safety in Pregnancy
A key task for the SIG is to regularly review the “Overview of data sources for drug safety in pregnancy research” that was developed by the University of Bath as a deliverable of an EMA funded study on the safety of A/H1N1 vaccines in pregnant women.
SIG on Measuring the Impact of Pharmacovigilance Activities
The mandate of the ENCePP SIG on Impact is to provide recommendations (e.g. in form of guidance documents or publications in peer-reviewed journals) to the PRAC Interest Group (IG) on Impact on the key methodologies for measuring health outcomes of pharmacovigilance activities which contribute to the overall evaluation of the impact of pharmacovigilance systems in line with the PRAC Strategy on Measuring the Impact of Pharmacovigilance Activities.
