Workshop on The Benefits of a Simplified and Coherent Clinical Trials Framework in Europe







The revision of the Clinical Trials Directive is a key legislative dossier for the EU health community, as it has the potential to improve timely patients’ access to safe, effective and high quality medicines while improving Europe’s competitiveness in the field of clinical research. An open and informed debate on a new framework for clinical trials in Europe is necessary so that we can achieve better outcomes for patients, and further develop the knowledge-based economy in Europe.

To this end, EuropaBio organised a parliamentary workshop on the revision of the Clinical trials Directive on 1 December, in the European Parliament in Brussels. The workshop, hosted by Prof. Philippe Juvin, MD PhD, MEP, was helpful in bringing the voices of all stakeholders around the table to discuss ways to move forward in the upcoming revision of this important Directive. It attracted more than 100 participants from EU institutions, patient organisations, industry, academia, regulatory agencies and ethics committees. A copy of the EuropaBio press release, the programme, presentations and speakers’ biographies can be found below. 
For further information on the workshop, please contact Pauline Bastidon, EuropaBio Healthcare Biotechnology Manager. 

Press Release: Link

Media Coverage: Link
Programme: Link
Speakers' biographies: Link
Pictures from the event: Link

  • Introduction
    Dr. Detlef Niese, Head of Global Development External Affairs, Novartis Pharma AG, and Vice-Chair for Science, EuropaBio Healthcare Council 
    Link to presentation
  • Revision of the Clinical Trials Directive: State of Play and Next steps
    Patricia Brunko, Head of Unit D3 – Pharmaceuticals, DG SANCO, European Commission 
    Link to presentation
  • Patients’ Perspective: A Viewpoint from Patients Living with Rare Diseases
    Flaminia Macchia, EU Public Affairs Director, EURORDIS
    Link to presentation
  • Industry’s Perspective
    Dr. Christiane Abouzeid, Head of Regulatory Affairs, BioIndustry Association (BIA), and Topic Leader, EuropaBio Clinical Trials Topic Group
    Link to presentation
  • Academia’s Perspective
    Prof. Hubert E. Blum, President, Federation of European Academies of Medicine (FEAM) and Dean of Medicine, University of Freiburg 
    Link to presentation
  • Experience with the harmonisation of multinational clinical trials and CTD revision: Member States’ perspective
    Dr. Hartmut Krafft, Co-Chair, EU Heads of Medicines Agencies' Clinical Trials Facilitation Group, Coordinator of the Voluntary Harmonisation Procedures and Head of the Clinical Trials Section, Paul-Ehrlich Institute, Germany
    Link to presentation
  • Health professionals/Ethics Committees’ Perspective
    Prof. Olivier Chassany, Chairman of a French Ethics Committee, Paris, and Medical Head of the Department of Clinical Research and Development, AP-HP (Assistance Publique – Hôpitaux de Paris)
    Link to presentation