Opening session: Navigating Europe’s HTA Future; Policy Implementation and Global Pressures
Moderated by
Karen Facey, RWE4Decisions Facilitator
François Meyer, RWE4Decisions Facilitator
09:35-09:50
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
09:50-10:10
Multistakeholder panel: The geopolitical shifts impacting HTA/Payers in the EU
Roisin Adams, Head of HTA Strategy National Centre for Pharmaeconomics, Ireland
10:10-10:30
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
10:30-10:40
Keynote: Status of the EHDS Implementation, Implementing Acts, TEHDAS Work
TEHDAS representative
10:40-10:55
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
10:55-11:10
Moderated Q&A with the audience
Roisin Adams, Head of HTA Strategy National Centre for Pharmaeconomics, Ireland
11:10-11:40
Break
Multistakeholder panel discussion: Policy and methodology for AI in RWD Collection
Moderated by
Niklas Hedberg, TLV
11:40-11:50
Keynote: The EMA/FDA 10 principles for AI to generate decision-grade RWD
TEHDAS representative
11:50-12:10
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
12:10-12:25
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
12:25-12:35
Review of RWE4Decisions Activities in 2026
Karen Facey, RWE4Decisions Facilitator
12:35-12:55
Next steps for RWE4Decisions: Steering Group discussion
Roisin Adams, Head of HTA Strategy National Centre for Pharmaeconomics, Ireland
12:55-13:00
Wrap-up and next steps
Roisin Adams, Head of HTA Strategy National Centre for Pharmaeconomics, Ireland