The symposium "Clinical trials: from European perspective to National Implementation" took place on November 19th 2010 and was organised by the European Clinical Trials Facilitation Group (CTFG), the Belgian Federal Agency for Medicinal and Health Products (FAMHP) and pharma.be, the federation of the Belgian Pharma industry. The importance of clinical research for Belgium is multiple: not only does the conduct of clinical trials deliver a substantial contribution to the economy in the form of investments and jobs, but clinical trials are also a driver for the financing of scientific and academic research. Both are important drivers in a knowledge economy, that contribute to innovation and to the development of better medicines for mankind.

Europe may be lagging behind in clinical research activities, as compared to other regions. In order to be competitive in this domain, the European Union needs to put in place an efficient framework and there is a need for further incentives for R&D all across Europe as well. Therefore, the European Commission is reconsidering the global context of clinical research with the aim to harmonise and simplify, with the objective to make the processes more lenient and efficient.

Important national and international speakers elaborated on the subject on November 19th 2010.

Presentations of the national and international speakers during the event:

1. Introduction from an industry and an NCA point of view

 G. Musch (FAMHP): "Introduction"

2. Feedback on topics from first day, reactions from industry and EC and proposals on how to proceed especially for (N)IMP issue

 C. Bélorgey (CTFG): "Feedback on topics from first day"

 E. Godfrey (MHRA) : "IMPs/NIMPs - Background therapy in Oncology Trials"

3. "One-stop-shop"

 S. Führing (EC): "One-stop-shop"

 Point of view Industry: L. Uylenbroeck (HST): "Clinical trials in Europe and in particular in Belgium: the "one-stop-shop" as a necessary condition for continuity, survival or growth?"

4. Non-Interventional trials: Need for a regulatory framework?

 G. Musch (FAMHP) : "Introduction"

 M.A. Serrano (AEMPS) : "Spanish regulation and experience regarding non-interventional post-authorisation studies (NIS)"

 C.-L. Julou (EFPIA): "Various considerations"

 M. Podoor (pharma.be) : "Industry view"

 F. Meunier (EORTC) : "The Academic point of view"

5. Safety in clinical trials : from detection to decision (how safety events are captured and treated by promoters and NCA's)

 E. Stahl (BFARM): "CTFG -NCA's view"

 S. Luik (EFPIA): "Safety Reporting in Clinical Development - Points to consider"

 N. Dubois (EORTC): "Experience of an academic sponsor regarding the safety reporting process for clinical trials"

Click here for the list of participants.