The implementation of the HTA regulation is well underway and all stakeholders are actively preparing for the application of the Regulation and the future EU HTA system, starting in January 2025. European methodologies and process proposals have been developed and are now up for review by the HTA Coordination Group and its recently established sub-groups. In parallel, the European Commission, Member States’ HTA Agencies, the European Medicines Agency, Industry, Patients and Clinicians’ organisations and all stakeholders are delivering aligned with their respective action plans and the activities that remain to be accomplished in the year to come.
This Forum provides a neutral platform for the various stakeholders to discuss the several aspects that should be put into practice to create a successful European system that goes beyond the union of current national practices but focuses on joint work and accomplishes the primary goal of the HTA Regulation – contributing to faster patient access.
Goals of the Forum:
- Discuss various strategic elements related to the implementation of the HTA Regulation from the European Commission, EMA, HTA Coordination Group, Industry, Member States’, Patients’ and Clinicians’ perspectives.
- Provide an opportunity to ask the burning questions that will inform internal company’s preparedness and discussions, such as inter-department preparedness (e.g. HTA, regulatory and clinical development) or future methodologies and processes for the joint clinical assessment (JCA).
- Assist in navigating the on-going policy discussions.
- Give insights into the work of Heads of HTA Agencies and European Commission’s Member State Coordination Group on HTA, and their expected activities for 2024.
Free Webinar: Essentials on Health Technology Assessment (HTA) and the EU Regulation (HTAR)
“Accompanying the HTA Forum, this webinar goes through the key steps of the HTA process and provides you with the knowledge foundation of the EU HTA Regulation and its implications for national authorities and stakeholders. Watch the complimentary webinar, now available online.”
Ansgar Hebborn, PhD, MBA • Head - Access Policy Affairs Europe
F. Hoffmann-La Roche AG, Switzerland
Claudine Sapède, PharmD • Director, Global HTA Policy
NOVARTIS INTERNATIONAL, Switzerland
Inka Heikkinen, MBA, MS, MSc • Director, Global Regulatory Policy
Lara Wolfson • Exec. Dir., Biostatistics Biostatistics & Res Decision Sciences
MSD Switzerland, Switzerland
Matias Olsen • Public Affairs & Policy Manager
European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Belgium
Maya Matthews • Head of Unit State of Health, European Semester, Health Technology Assessment
European Commission , Belgium
Michael Berntgen, PhD • Head of Scientific Evidence Generation
European Medicines Agency, Netherlands
Niklas Hedberg, MPharm • Chair EUnetHTA Executive Board
Dental and Pharmaceutical Benefits Agency, TLV, Sweden
Rui Santos Ivo • President, Executive Board
INFARMED - National Authority of Medicines and Health Products, Portugal
Valentina Barbuto • Policy Officer
European Commission, Belgium
Valentina Strammiello, MA • Head of Programmes
European Patients' Forum, Belgium
Sara Torgal, MPharm • Senior Manager, Scientific Programs
Ramiro Gilardino • Global HTA & Access Policy Lead
MSD Switzerland, Switzerland