The final IHI FACILITATE project event will present at the EU Parliament the project’s main results within the framework of the MEPs Interest Group on Patients’ Rights and Cross-Border Healthcare. Clinical trials generate valuable individual-level data, which is rarely returned to participants. FACILITATE has addressed this gap by developing an ethically and legally robust framework for the Return of Individual Participant Data (RoIPD) in the EU. The event – hosted by the MEP Vytenis Andriukaitis - will highlight progress made in shaping RoIPD processes in line with EU law, including the Clinical Trials Regulation (CTR) and GDPR, while drawing on international best practices. It will showcase how RoIPD can empower participants, improve health literacy, and advance medical research.

A key outcome will be offering practical recommendations for the ethical, legal, and operational implementation of RoIPD. This guidance is intended to support patients, researchers, private sectors, healthcare providers, and regulators in making RoIPD a reality across Europe. Read more about the IHI FACILITATE project.

AGENDA
REGISTER HERE for online participation

European Parliament, Brussels - Room A3H1
4th December 2025- 12:30 -14:00

Moderator – Nuala Ryan (Public Private Partnership Team, Takeda; Clinical Research Consultant and Patient Advocate)

12:30 – 12:45 | Opening Session

• Welcome remarks – MEP Vytenis Andriukaitis, S&D Group, Lithuania (event host)
• Keynote address – Elmar Nimmesgern, Research & Innovation DG, Combatting Diseases, European Commission (online)

12:45 – 13:10 | Presentation of FACILITATE Results

Main outcomes of FACILITATE:

Johanna Blom, FACILITATE Coordinator; Professor of Psychobiology, Università di Modena e Reggio Emilia (UNIMORE) & Cris Woolston, Global Head of Science Policy, Sanofi

FACILITATE Principles: Daniela Quaggia, Cittadinanzattiva - Active Citizenship Network

13:10 – 13:35 | Roundtable Discussion Perspectives on the FACILITATE results and their implications:

• Nadia Malliou – Patient association representative, Pain Alliance Europe & Hellenic League Against Rheumatism
• Veronica Franchina – Data Manager, GIDM (Italian Group of Data Managers & Clinical Research Coordinators), Papardo Hospital, Messina
• Karen Cruyt – Coordinator, GDPR Working Group, Belgian Association of Research Ethics Committees (BAREC)
• Sean Byrne – Associate Director, Research & Regulatory, European Federation of Pharmaceutical Industries and Associations (EFPIA)

13:35 – 13:50 | Open Q&A with Audience

13:50 – 14:00 | Conclusions & Next Steps

The FACILITATE project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 101034366. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.