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Clinical Trial Events
DIA Europe

Talk Value & Access track

S1002 - HTA Townhall: Outlook and Opportunities for Translating Regulatory Approval into Access Decisions

Wed, Mar 19, 2025 · 10:30–11:40 AM CET San Francisco Room, Congress Center Basel

About this session

The HTA Regulation embraces the bridge between regulatory decision making and subsequent health technology assessment, providing an EU level framework for interaction between decision makers. By the time of DIA Europe 2025, operations under the new legal framework have just started; there will be a very high degree of attention to these new proceedings including the interoperability between the regulatory and the HTA review activities.

The session’s objective is to discuss with different decision makers and developers the opportunities and challenges when going through sequential reviews towards patient access.

Furthermore, there are also opportunities through collaborative work on the management of uncertainties. Here perspectives by the panellists should provide the foundation to further inform methodological work to fertilise different types of decision making.

Programme:
- Panel Discussion — Michael Berntgen, Matteo Scarabelli
- 1. Introduction to the HTAR and Current Status in the JSC Work — Sonia Pulido Sanchez
- 2. EUPATI’s View on HTAR — Mitchell Silva

Speakers

  • Mitchell Silva

    Chair · EUPATI Belgium vzw

    Speaker

  • Matteo Scarabelli

    Market Access, Associate Director · EFPIA - European Federation of Pharmaceutical Industries and Associations

    Panelist

  • Sonia Pulido Sanchez

    HTA Project Manager and JSC SG Co-Chair · AEMPS

    Speaker

  • Michael Berntgen

    Head of Evidence Generation Department · European Medicines Agency

    Panelist

  • Niklas Hedberg

    HTACG Co-Chair & Chief Pharmacist · Dental and Pharmaceutical Benefits Agency, TLV

    Chair