Mobilising Real-World Data to Enhance HTA/Payer Decision-Making

Co-moderators: Karen Facey and François Meyer (RWE4Decisions facilitators)

  • 20 November 2025
  • 14:00 - 17:00 CET
  • Online
  • 20 November 2025
  • 14:00 - 17:00 CET
  • Online
Register here

Welcome and opening statement – Karen Facey

14:00-14:10

10 min

Welcome and review of RWE4Decisions activities in 2025

Opening Session – Moderated by François Meyer

14:10-14:25

15 min

Keynote address: Implementing the HTA Regulation: Shaping the Future of EU Collaboration in Health Technology Assessment

Maya Matthews, Deputy Director General for Digital, EU4Health and Health Systems Modernisation, DG SANTE, European Commission

14:25-14:35

10 min

Keynote address: Real-World Data and Health Policies – Danish EU Council Presidency’s Achievements

Hans Juul Hedegaard, Head of Unit, Director General’s Office, Danish Medicines Agency

14:35-14:45

10 min

Keynote address: DARWIN EU: Harnessing EU-Wide Real-World Evidence to Inform HTA/Payer Decisions

Denise Umuhire, Pharmacoepidemiology & RWE Specialist, Data Analytics and Methods Task Force, European Medicines Agency (EMA)

14:45-15:30

45 min

Multi-stakeholder panel discussion and Q&A with audience

Speakers:

Elizabeth Vroom, Chair, World Duchenne Organisation

Cláudia Furtado, Director of the Divisions of Information and Strategic Planning and Health Technology Assesment, INFARMED

Matias Olsen, Senior Manager, Public Affairs & Policy, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)

Hans Juul Hedegaard, Head of Unit, Director General’s Office, Danish Medicines Agency

Denise Umuhire, Pharmacoepidemiology & RWE Specialist, Data Analytics and Methods Task Force, European Medicines Agency (EMA)

Q&A led by Karen Facey

15:30-15:35

5 min

Break

Breakout room sessions: Reducing decision-relevant uncertainties using fit-for-purpose RWD

15:35-16:10

35 min

Room 1: EU Payers focus

Facilitator:

Benedetta Baldini, Senior Policy Advisor, European Social Insurance Platform (ESIP)

Scribe:

Melinda Hanisch, Science and Regulatory Policy, MSD

Room 2: EU HTA focus

Facilitators:

Andre Vidal-Pinheiro, Head Patient Value & Access EUCAN, Takeda

Anja Schiel, Senior Advisor, Norwegian Medical Products Agency (NoMA)

Scribe:

Matias Olsen, Senior Manager, Public Affairs & Policy, EUCOPE

Room 3: International focus (UK and Canada)

Facilitators:

Colette Raymond, Scientific Advisor, Canada’s Drug Agency (CDA-AMC)

Eleanor Yelland, Scientific Advisor, National Centre for Health and Care Excellence (NICE)

Scribe:

Rafaël Minacori, Head of Access EU & International & Global HEOR HIDO, Chiesi

Closing session: How can we better mobilise the use of RWD in HTA?
Moderated by Karen Facey

16:10-16:55

45 min

Feedback from breakout groups

RWE4Decisions Steering Group reflections: RWE4Decisions in 2026 – supporting stakeholder collaborations and dialogues

Francis Arickx, Head of Pharmaceutical Policy Directorate, INAMI-RIZIV

Niklas Hedberg, Chief Pharmacist, TLV

Eric Sutherland, Senior Health Economist, OECD

Lara Wolfson, Associate Vice-President & Head, HTA Statistics, MSD

16:55-17:00

5 min

Wrap up and next steps

Meeting Close