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.
Active WGs
Communications and Outreach
Objectives:
- Develop a communication plan to coordinate activities and efforts across the ENCePP Steering Group, WGs, SIGs, and Secretariat
- Enhance the dissemination of ENCePP’s tools, guidance, and updates to the pharmacoepidemiology and pharmacovigilance communities, thus increasing visibility and accessibility to researchers, regulators, and other stakeholders across Europe and globally
- Establish metrics for evaluating the impact of communication and outreach activities, allowing for continuous improvement and adaptation
Chairs: Katica Boric (RTI Health Solutions), Joana Abrantes (Pharmacovigilance and Pharmacoepidemiology, AIBILI)
Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology
Objectives:
- Select and deliver revised (sub)chapters for Revision 12, for update of the Guide on the ENCePP website
- Develop a strategy for further periodic revisions and improvements
Chairs: Nhung Trinh (UiT – The Arctic University of Norway), Tania Schink (Leibniz Institute for Prevention Research and Epidemiology – BIPS)
Independence and Transparency
Objectives:
- Update the ENCePP Code of Conduct, support its use, and explore ways of improving its uptake
- Promote registration of studies in the HMA-EMA Catalogues of RWD studies and support EMA in the further development of the Catalogues with regards to transparency and use of the Code of Conduct
Chairs: Rosa Gini (ARS Toscana), Elena Petelos (European Forum for Primary Care - EPFC)
Artificial Intelligence (AI) in Pharmacoepidemiology
Objectives:
- Map current uses and perceptions of AI within pharmacoepidemiology across the ENCePP network and related stakeholders
- Critically appraise available AI tools relevant to the field
- Foster collaboration and knowledge exchange with other ENCePP groups
- Disseminate learnings through targeted educational activities
- Define subsequent deliverables following completion and evaluation of the initial mapping phase
Chair: Maurizio Sessa (Drug Safety Group, University of Copenhagen)
Diversity and Health Equity
Objectives:
- Enhance awareness of the definitions of diversity and equity in pharmacoepidemiology
- Contribute to the integration of diversity and health equity into ENCePP tools and actionable guidelines, and reinforce best practices in pharmacoepidemiology studies to benefit all populations equally
- Support the development of methodological standards that help the identification and analysis of a diverse population, including underrepresented groups
- Facilitate that data from all patients, including those with challenges accessing healthcare, are available and used in observational research to enable studies to reliably identify and quantify health disparities
Chairs: Flavia Soares Peres (IQVIA), Taichi Ochi (University of Groningen)
Real-World-Data (RWD) sources in non-interventional studies
Objectives:
- Metadata framework: Identify and standardise priority metadata fields most relevant for early planning of non-interventional study (NIS)
- Common Data Models Review: Provide a concise overview of how selected RWD sources use CDMs and other harmonisation methods, and the implications for NIS feasibility
- Fitness-for-Purpose Assessment Tool: Develop a lightweight scoring matrix to evaluate whether a data source is fit for specific NIS types (e.g., utilisation, safety, effectiveness)
- Provide illustrative governance and onboarding “archetypes” to guide realistic planning of study initiation for NIS
- Targeted Case Illustrations: Provide a small set of practical cases showing how the WG tools help feasibility and overcome planning challenges in NIS
- Produce a short guide showing how the WG tools (metadata framework, scoring matrix, governance archetypes) complement existing catalogues to avoid duplication and improve practical utility
- Consolidated Guidance Document: Synthesise all WG outputs into a comprehensive, user-friendly guidance document to support feasibility assessment, study planning, and regulatory alignment for NIS
Chairs: Christos Kontogiorgis (Democritus University of Thrace), Martín Solórzano (Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol)
Active SIGs
Pragmatism in Clinical Trials
Objectives:
- Highlight the value of pragmatic approaches in CT, and for which context (clinical and regulatory) and research questions this type of approaches is most suitable
- Foster consensus on:
- Terminology summarising the different definitions currently used with the aim to help providing clarity (pragmatic CT, trials with RWD, low intervention clinical trials, large simple trials, decentralised clinical trials, etc)
- Core methodological and design principles (study purpose, population and setting, intervention and comparator, randomisation and blinding, outcome measures)
- Data quality control and assurance measures in the setting of CT with pragmatic elements
- Support training and capacity building: enhance expertise among ENCePP partners by providing educational webinars or workshops
- Expand awareness and support collaborative efforts
Chairs: Georgios Papazisis (Aristotle University, Thessaloniki), Gianmario Candore (EMA)
Update of the ENCePP Checklist for Study Protocols
- Objective: Update the Checklist considering the most recent relevant regulatory and scientific guidance
- Chair: Katja Hakkarainen (Parexel)
Supplement to the Good Practice Guide for the use of the HMA-EMA Catalogues of real-world data (RWD) sources and studies
Objectives:
- Develop Use Cases and Examples: Use the Good Practice Guide as the foundation for defining use cases, expand with additional relevant use cases to cover broader scenarios, and identify concrete study examples to illustrate Catalogue application
- Test the Catalogues: Agree on a methodological approach for testing the Catalogues using the defined use cases, and test the use cases with real examples to identify best practices, optimal use, and existing gaps
- Translate Findings into Guidance: Develop clear guidance and training materials based on testing outcomes, identified gaps, and deliver recommendations to inform future improvements
Chairs: Pierre Engel (IQVIA), Martín Solórzano (Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol)
Publication of selected chapters of the ENCePP Guide in Pharmacoepidemiology and Drug Safety and Value in Health
Objective: Select chapters suitable for publication in collaboration with the journals, and coordinate manuscript development.
Chair: Helga Gardasdottir (Utrecht University)
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.
