RWE4Decisions Symposium: Mobilising Real-World Data to Enhance HTA/Payer Decision-Making

November 20, 2025

14:00-17:00 CET

Online

Our Roundtables are by-invitation only meetings, held under Chatham House Rule. If you wish to be invited, please contact the Secretariat and we will review you request.

On 20 November 2025, from 14:00 to 17:00 CET, RWE4Decisions will hold its annual Symposium online: “Mobilising Real-World Data to Enhance HTA/Payer Decision-Making“, moderated by Karen Facey and François Meyer (RWE4Decisions Facilitators). We will spotlight the evolving EU health data landscape, shaped by the implementation of the Health Technology Assessment (HTA) and European Health Data Space Regulations (EHDS). We will also reflect on the role of RWE4Decisions as a unique platform to bring all stakeholders together – HTA/Payers, industry, clinicians, policymakers, registry holders, patients – to exchange about the evolving role of Real-World Evidence (RWE) in enabling patient access to innovative medicines.

Programme

14:00-14:10

Welcome and review of RWE4Decisions activities in 2025

14:10-14:45

Opening session: HTA and RWD Developments in the EU - How do we maximise use of RWE in decision-making?

Maya Matthews

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

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)

14:45-15:30

Multi-stakeholder panel discussion and Q&A with audience

Elizabeth Vroom

Chair, World Duchenne Organisation

Cláudia Furtado

Director of the Divisions of Information and Strategic Planning and of Health Technology Assessment, 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)

15:30-15:35

Break

15:35-16:10

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

Room 1: EU Payers focus

Facilitator: Benedetta Baldini

Senior Policy Advisor, European Social Insurance Platform (ESIP)

Scribe: Melinda Hanisch

Global Evidence and Regulatory Policy, MSD

Room 2: EU HTA focus

Facilitator: Anja Schiel

Senior Advisor, Norwegian Medical Products Agency (NoMA)

Facilitator: Andre Vidal-Pinheiro

Head Patient Value & Access EUCAN, Takeda

Scribe: Matias Olsen

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

Room 3: International focus (UK and Canada)

Facilitator: Colette Raymond

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

Facilitator: Eleanor Yelland

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

Scribe: Rafaël Micacori

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

16:10-16:55

Closing Session: How can we better mobilise the use of RWD in HTA?

Feedback from breakouts

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

Wrap-up and next steps

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