Optimising RWE to deliver value in healthcare

Participant arrival and registration

Welcome and opening statement

Welcome and housekeeping

Karen Facey, RWE4Decisions Facilitator

Opening session: Navigating Europe’s HTA Future; Policy Implementation and Global Pressures

Moderated by

Karen Facey, RWE4Decisions Facilitator

François Meyer, RWE4Decisions Facilitator

Keynote address: Irish Presidency of the Council of the EU – State of the Nation on the Implementation of the HTA Regulation, with a focus on JCAs and JSCs

Roisin Adams, Head of HTA Strategy National Centre for Pharmaeconomics, Ireland

Multistakeholder panel: The geopolitical shifts impacting HTA/Payers in the EU

Roisin Adams, Head of HTA Strategy National Centre for Pharmaeconomics, Ireland

Moderated Q&A with the audience, including keynote speaker

Roisin Adams, Head of HTA Strategy National Centre for Pharmaeconomics, Ireland

Multistakeholder panel discussion: The European Health Data Space – Readiness, Challenges, and the Road to Implementation

Moderated by

Eric Sutherland, OECD

Keynote: Status of the EHDS Implementation, Implementing Acts, TEHDAS Work

TEHDAS representative

Initial reflections: A multistakeholder view of the key opportunities and challenges in EHDS implementation

Roisin Adams, Head of HTA Strategy National Centre for Pharmaeconomics, Ireland

Moderated Q&A with the audience

Roisin Adams, Head of HTA Strategy National Centre for Pharmaeconomics, Ireland

Break

Multistakeholder panel discussion: Policy and methodology for AI in RWD Collection

Moderated by

Niklas Hedberg, TLV

Keynote: The EMA/FDA 10 principles for AI to generate decision-grade RWD

TEHDAS representative

Initial reflections: How to ensure that AI-generated RWD meets HTA, patient, and societal needs?

Roisin Adams, Head of HTA Strategy National Centre for Pharmaeconomics, Ireland

Moderated Q&A with the audience

Roisin Adams, Head of HTA Strategy National Centre for Pharmaeconomics, Ireland

Closing session: Patient-relevant RWE; key learnings and next steps for RWE4Decisions

Moderated by

Karen Facey, RWE4Decisions Facilitator

Review of RWE4Decisions Activities in 2026

Karen Facey, RWE4Decisions Facilitator

Next steps for RWE4Decisions: Steering Group discussion

Roisin Adams, Head of HTA Strategy National Centre for Pharmaeconomics, Ireland

Wrap-up and next steps

Roisin Adams, Head of HTA Strategy National Centre for Pharmaeconomics, Ireland

Networking lunch