15+ years of ENCePP: what has been achieved, what’s next, and what’s in for ISPE

Background: The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) was launched by the European Medicines Agency (EMA) in 2007, and has become a large community bringing together expertise and resources for discussions on methods and conduct of non-interventional studies, based on principles of transparency, scientific independence, and common quality standards. In 2018, ENCePP hosted a 10th anniversary symposium at the 34th ICPE. Today, in the wake of the COVID-19 pandemic, its role in the European and global pharmacovigilance, pharmacoepidemiology and real-world evidence (RWE) ecosystem remains key. In a fast-changing RWE landscape, ENCePP is also evolving and continues to fulfill its mission through an adapted governance, impactful workplan, and enhanced multi-stakeholder engagement.

Objectives: 1. To inform on recent ENCePP updates and their potential benefits for the ISPE community;
2. To position the current work of ENCePP in a fast-changing and more global environment;
3. To exchange views with ISPE members on future directions for ENCePP.
This symposium provides an opportunity for ICPE participants to learn from the ENCePP community and to actively contribute to continue shaping its future.

Description: The symposium will kick-off with ENCePP’s achievements and lessons learned since its inception, and an overview of highlights since the 10th anniversary, including its role during the COVID-19 pandemic. The workplan for the current mandate (2024-2026) will be presented.
Speakers representing the ENCePP and ISPE communities will provide their views on how ENCePP supports medicines evaluation and pharmacoepidemiological research and discuss the value of, and new developments for key ENCePP tools such as the Guide on Methodological Standards in Pharmacoepidemiology and the Code of Conduct, as well as recent experience with the new Heads of Medicines Agencies (HMA)-EMA Catalogues of real-world data (RWD) sources and studies launched in February 2024, building on the former ENCePP Resource Database and EU PAS Register.
With the ambition of ENCePP to deliver a workplan based on increasing engagement with learned societies, panelists will discuss how cross-fertilisation and communication can be enhanced, and how common strategic and operational objectives can be identified and leveraged with ISPE to support our field globally. Insights from this symposium will inform the workplan moving forward. Participation of the audience will be encouraged to exchange on future orientations for this important initiative for pharmacoepidemiology.