RWE over the lifecycle of ATMPs to meet the HTA (Regulation) Needs

March 26, 2024
15:00-16:30 CET
Online

Join us on 10 October for the RWE4Decisions webinar on how RWE over the lifecycle of ATMPs could support the EU joint HTA work. You will hear from Prof Ana Hidalgo-Simon, who will set the scene on the clinical and regulatory context for ATMPs in the EU. A multi-stakeholder panel will then follow, representing the voices of HTA bodies, payers, patients and industry, on the opportunities and challenges with RWE generation and assessment for ATMPs.

Programme

15:00

Welcome from the co-moderators (RWE4Decisions Steering Group)

Eric Sutherland

Senior Health Economist, Organisation for Economic Co-operation and Development (OECD)

Karen Facey

RWE4Decisions Facilitator

15:10

Keynote Presentation

Ana Hidalgo-Simon

Associate Professor, Leiden University Medical Center

15:25

Panel Discussion

Niklas Hedberg

Chief Pharmacist, Swedish Dental and Pharmaceuticals Benefits Agency (TLV), RWE4Decisions Steering Group Member

Christoph Rupprecht

Head of Department Health Policy & Health Economics, Allgemeine Ortskrankenkasse (AoK)

Simone Boselli

Public Affairs Director, EURORDIS-Rare Diseases Europe, RWE4Decisions Steering Group Member

Alexander Natz

Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), RWE4Decisions Steering Group Member

16:20

Closing remarks by the co-moderators

Eric Sutherland

Senior Health Economist, Organisation for Economic Co-operation and Development (OECD)

Karen Facey

RWE4Decisions Facilitator

16:30

Meeting close

Background

Under the EU Health Technology Assessment Regulation (HTAR), oncology medicines and Advanced Therapeutic Medicinal Products (ATMPs) will be the first to undergo Joint Clinical Assessments, starting in January 2025. As there is often a paucity of clinical evidence available for these highly innovative treatments, the 2023 RWE4Decisions webinar series will consider the potential for use of Real-World Data (RWD), given there is no EU-wide guidance on Real-World Evidence (RWE) generation or use.

Other past events

Public Webinar: From Policy to Practice: EHDS Implementation to Support Better Real-World Evidence for HTA/Payers

April 9, 2025
15:00-16:30 CEST
Online

RWE4Decisions Symposium: Developing Real-World Evidence to Deliver Innovation in HTA

November 14, 2024
09:00-13:00 CET
Hybrid

Public Webinar: HTA/Payer Collaboration in the Nordics: The Role of Real-World Evidence

October 23, 2024
15:00-16:00 CEST
Online