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SHAPING EUROPEAN EARLY DIALOGUES: THE SEED PROJECT
Session Chair(s)
François Meyer, MD
Advisor to the President, International Affairs
French National Authority for Health (HAS), France
SEED is a project funded by the European Commission involving 14 HTA bodies from 10 countries and coordinated by HAS (France). The main objectives are: 1) the conduct of 10 early dialogues (ED) between companies and HTA bodies on the development of new pharmaceuticals and medical devices and 2) the proposal for a permanent model for ED in Europe. The session will provide an update on the advancement of the project and preliminary results, with discussion on the benefits and potential challenges for the future of this activity.
Learning Objective : Describe the process of early dialogues between multiple HTA bodies and pharma companies, interaction with regulatory scientific advice. Compare various procedural modes for early dialogues. Propose options for a permanent model of early dialogues in Europe.
Speaker(s)
Early Dialogues Involving Multiple HTA Bodies: Lessons learnt and future challenges
François Meyer, MD
French National Authority for Health (HAS), France
Advisor to the President, International Affairs
Early Dialogue and SEED Project: The perspective from a pharmaceutical company
Luk A Maes, DrMed, DRSC
Bristol-Myers Squibb International Corporation, Belgium
Executive Director Scientific Policies Europe
Early Dialogue and SEED Project: The perspective from small companies
Emmanuelle Voisin, PHD
Voisin Consulting Life Sciences, France
CEO and Principal
The European Commission Perspective
Jerome Boehm, MBA
European Commission, Belgium
Administrator/ Policy Officer