Presentation

Aim of this european meeting is to discuss the ongoing implementation and to forecast systemic consequences of the HTA Regulation (EU) 2021/2282, which will come into force on January 2025.

It will bring together in situ, leading figures from European and national HTA bodies as well as socio-economic players including European patients, physicians and entrepreneurs organizations, for direct, convivial, fruitful interactions.

Attendees are advanced students and academic researchers, national regulators, public & private decision makers operating in the fields of HTA and public governance, pharmaceutical law and regulatory affairs, market access.

This meeting is a pilot – the first of a series focusing on our Nations and Union transformations and future performance facing existential challenges … and opportunities ?

150 seats – non-hybrid event – no registration fees motivated application – full english, no translation.

Programm

8h30 : Welcome in room

9h00 : Address, welcome to the European Parliament
Fabienne Keller, Member of the European Parliament, & Quaestor, European Parliament
Pr. Frédérique Berrod, Vice-présidente, University of Strasbourg / EUCOR

9h10 : How to end « multiple and divergent requests for data ? »
Pr. Filippo Drago, Chairman CERD, University of Catania, Italy

RT 1 – From EUnetHTA, to the Health Technology Assessment Regulation : implementing measures update

Anne Willemsen, Senior Advisor, Dutch National Healthcare Institute (ZIN), The Netherlands & Co-chair of the Joint Clinical Assessment Subgroup, HTACG
Dr. Leslie Pibouleau, Senior policy officer, DG SANTE, European Commission, Brussels
Judith Fernandez, D-Director, HTA Department in charge of international affairs, Haute Autorité de Santé, France

RT 2 – Joint Clinical Assessment : issues, choices and methodological challenges ?

Moderator : Judith Fernandez, D-Director, HTA Department in charge of international affairs, HAS, France

Dr. Roisin Adams, Head, HTA Strategy and External Engagement, National Centre for PharmacoEconomics, Ireland & Chair, European HTA Coordination Group (HTACG)
Dr. Paul de Boissieu, Project Manager, Drug Assessment Division, Haute Autorité de Santé (HAS) France & Chair of the Joint Clinical Assessments Subgroup, HTACG
Dr. Beate Wieseler, Head, Department of drug assessment, IQWIG, Germany & Chair of the Methodological and Procedural Guidance Subgroup, HTACG
Anne Willemsen, Senior Advisor, Dutch National Healthcare Institute (ZIN), The Netherlands & Co-chair of the Joint Clinical Assessment Subgroup,  HTACG

12h00 : Lunch-Buffet (Atrium)

13h30 : What could the national « due consideration » to JCA mean ?
Pr. Francis Megerlin, Head Séminaires SBD, University of Strasbourg / EUCOR

RT3 – National reception of Joint Clinical Assessments :   what impact for decision support ?

Moderator : Dr.Heiner Haug, Chairman, HTA Europe Committee Leem & Astrazeneca, France

Dr. Roisin Adams, Head, HTA Strategy and External Engagement, National Centre for PharmacoEconomics, Ireland & Chair, European HTA Coordination Group (HTACG)
Pr. Pierre Cochat, Président, Commission de la Transparence, Haute Autorité de Santé, France
Dr. Pierluigi Russo, Executive Director, Agenzia Italiana del Farmaco (AIFA), Italy
Pr. Rui Santos Ivo, President of the Executive Board, National Authority of Medicines and Health Products (Infarmed), Portugal
Dr. Michal Staňák, founding Director, National Institute for Value and Technologies in Health Care (NIHO), Slovakia
Dr. Beate Wieseler, Head, Department of drug assessment, Institut for Quality and Efficiency in Health Care (IQWIG), Germany & Chair of the Methodological and Procedural Guidance Subgroup, HTACG

RT4 – Joint Clinical Assessments : towards renewed socio-economic interactions ?

Moderator : Agnieszka Buelens, Head DATAETHICS, University Medical Center Goettingen

Pr. Elisabeth de Vries, University Medical Centre Groningen, Groningen, the Netherlands & Cancer Medicines committe, European Society for Medical Oncology (ESMO)
Dr. Ansgar Hebborn, Chair, HTA Working Group, European Federation of Pharmaceutical Industries and Associations (EFPIA)
Marie-Laure Hecquet, Policy advisor, Director Office, European Directorate for the Quality of Medicines & Healthcare (EDQM), Council of Europe
François Houÿez, Director of Treatment Information and Access, European Organisation for Rare Diseases (EURORDIS)
Dr. Alexander Natz, Secretary General, European Confederation of Pharmaceutical  Entrepreneurs (EUCOPE)
Julie Spony, Policy Officer, European Patient Forum (EPF)

Next Steps ?
Francis Megerlin & Filippo Drago

17h30 : Au revoir

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