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Europe: The Changing Dynamics of the Public Health Environment
Program Code:
3090
Date:
Wednesday, May 20, 2009
Time:
4:00 PM to 5:30 PM
EST
SPEAKER
(S):
Giulia Del Brenna, Head of Unit DG.ENTR.F.5 (Competitiveness in the pharmaceuticals industry and biotechnology), European Commission - Directorate General for Enterprise
Wills Hughes-Wilson, Chair of EuropaBio Advanced Therapies Task Force, Genzyme Belgium NV/SA
Tomas Jonsson, DG Enterprise, European Commission
Francois Meyer, Director, Health Technology Assessment Division, Haute Autorite de Sante
Andrea Rappagliosi, Merck Serono
Description
Industry, legislators and regulators will come together and look at overall trends in the development of the European Regulatory System for biotherapies — exemplified through recent policy initiatives at various stages of implementation such as the biosimilars legislation, the Advanced Therapies Regulation, and the Cross-Border Healthcare initiative. The various backgrounds represented by the speakers will allow for multifacetted explorations of the initiatives from both an industry, regulator and
legislator angle.
• Introduce the Evolution of the European Regulatory System for Bio-Therapies—from predictive biomarkers to implementation of the Advanced Therapies Regulation
• Debate whether Europe has delivered on public health policies 4 years after the biosimilars legislation: Is it on track?
• Explore Europe's recent Cross-Border Healthcare initiative— from a network of HTA agencies for Relative Effectiveness through to patient access to innovative treatments