EUROPEAN HEALTH TECHNOLOGY ASSESSMENT REGULATION : SHARING EXPERIENCE

IInd Conference on European Health Technology Assessment Regulation : Sharing Experience
European Parliament Strasbourg, June, Fri the 19th 

This IInd conference organized by the universities of Strasbourg and Catania and Séminaires Strasbourg Berkeley Descartes, will focus on the first year of implementation of the EU regulation 2021/2282 on health technologies assessment: methodological and legal aspects. The first technologies covered, effective January 2025, are oncology drugs and advanced therapy medicinal products. This conference offers a unique opportunity of direct interactions with HTACG (on line), with stake-holders and leaders of national HTA bodies (in situ), thanks to a small group of attendees and the effective presence of prominent keynote speakers that encourages discussion and open dialogue. 

Non hybrid-event *, full English, no translation.

Participation for the Buffet (the payment instructions will be sent by email after application).

Application Socio-economic stake-holders (participation for the Buffet 100 €)
https://ep-events.europarl.europa.eu/lincstrasbourg/2ndHTAR/e/lk/g/107145/k/
Subscribers to Séminaires Strasbourg-Berkeley-Descartes to not have to pay 

8.15 AM
RECEPTION IN THE HALL

8.45 AM
WELCOME AND INTRODUCTION
Prof. Filippo DRAGO & Prof. Francis MEGERLIN
ADDRESS FROM Tiemo WÖLKEN, Member of the European Parliament & rapporteur, HTAR

9.00 AM
MEMBER STATES COORDINATION GROUP ON HEALTH TECHNOLOGY ASSESSMENT (HTACG) ROLE IN THE JOINT CLINICAL ASSESSMENT PROCESS
Moderator, Prof. Jörg RUOF, Hannover Medical School, Germany
Roisin ADAMS, Chairman, HTACG & Head at HTA Strategy, National Centre for Pharmacoeconomics (NCPE), Ireland *
Anne WILLEMSEN, Co-chair HTACG & Zorginstituut Nederland (ZIN), The Netherlands *

EUROPEAN COMMISSION FEEDBACK ON THE FIRST JOINT CLINICAL ASSESSMENTS
Leslie PIBOULEAU, Policy Officer, European Commission - DG SANTE 

10.00 AM
PICO ELABORATION: STAKE-HOLDERS INVOLVEMENTS
Moderator, Dr. Heiner HAUG, AZ, past-chairman HTA Committee Leem
Observer, Prof. James C ROBINSON, UC Berkeley, director, Berkeley Center for Health Technology (BCHT)
With notably
Anne-Pierre PICKAERT, Patient Advocate, Acute Leukemia Advocates Network (ALAN)
Matias OLSEN, Associate Director, Market Access, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
Matteo SCARABELLI, Associate Director, Market Access, European Federation of Pharmaceutical Industries and Associations (EFPIA)
& attendees representing the first product candidates to the JCA process

12.00
BUFFET

1.45 PM
FROM PICO TO JOINT CLINICAL ASSESSMENT: NATIONAL HEALTH TECHNOLOGY ASSESSMENT AUTHORITIES PERCEPTIONS
Moderator, Prof. Filippo DRAGO, director CERD, University of Catania, Italy
With notably
Dr. Beate WIESELER, Head of Department, Drug Assessment, Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWIG), Germany
Prof. Pierre COCHAT, Chairman, Transparency Committee, Haute Autorité de Santé (HAS), France
Dr. Mariane COSSITO, Head of Health Technology Assessment Directorate, Autoridade Nacional do Medicamento e Produtos de Saúde (INFARMED), Portugal
Enrico COSTA, Head, International Office, Agenzia Italiana del Farmaco (AIFA), Italy
& interactions with attendees

PICO SCHEMES: HOW TO APPROACH THE EQUITY / EXCELLENCE DILEMMA?
Prof. Jörg RUOF, Hannover Medical School & founder, European Access Academy (EAA)

FROM JCA TO EX POST NATIONAL REQUEST: WHAT APPLICABLE LAW?
Prof. Francis MEGERLIN, Université de Strasbourg / CEIE & Senior Fellow BCHT, UC Berkeley

4.30 PM
AU REVOIR & WELCOME
Prof. Catherine LEDIG & Prof. Thomas MORGENROTH, université de Strasbourg

* Mrs Roisin Adam, Anne Willemsen and Leslie Pibouleau will exceptionally intervene on line due to HTACG obligation