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.
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.
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PROGRAMME
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Welcome from the co-moderators (RWE4Decisions Steering Group)
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Eric SutherlandSenior Health Economist, Organisation for Economic Co-operation and Development (OECD)
Karen FaceyRWE4Decisions Facilitator
Keynote Presentation
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Ana Hidalgo-SimonAssociate Professor, Leiden University Medical Center
Panel Discussion
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Niklas HedbergChief Pharmacist, Swedish Dental and Pharmaceuticals Benefits Agency (TLV), RWE4Decisions Steering Group Member -
Christoph RupprechtHead of Department Health Policy & Health Economics, Allgemeine Ortskrankenkasse (AoK) -
Simone BoselliPublic Affairs Director, EURORDIS-Rare Diseases Europe, RWE4Decisions Steering Group Member -
Alexander NatzSecretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), RWE4Decisions Steering Group Member
Closing remarks by the co-moderators
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Eric SutherlandSenior Health Economist, Organisation for Economic Co-operation and Development (OECD)
Karen FaceyRWE4Decisions Facilitator
