EMEA Conference

Dear EHA members,

EHA has received a request for nomination and registration of a delegate for the “European Commission – EMEA Conference on the operation of the Clinical Trials Directive (Directive 2001/20/EC) and perspectives for the future”. This conference will be held on October 3, 2007 at EMEA, London.

The scope of the conference is on the EU clinical trail legislation and its implementation in the context of clinical trials of medical products. The objective is to provide an overview of the experience to date with the operation of the Directives 2001/20/EC and 2005/28/EC and their implementing texts, and to describe problems encountered and offer recommendations for the future.

EHA is very interested in participating in the EMEA Conference and we are pleased that Robin Foà is willing to represent EHA. The EU clinical trail legislation and its implementation in the context of clinical trails of medical products are of high importance and EHA’s contribution to this discussion and conference is valuable and in conformity with our current plans related to lobbying and advocacy.

Part of the preparation for this conference is a written submission on behalf of the participating organizations/societies. EHA is already working on this submission but we would highly appreciate your contribution. The following topics need to be considered and reported on:

• Aspects of the Directive 2001/20/EC that work well
• Aspect of the Directive 2001/20/EC that do not work well
• What can be remedied within the present legal framework (by modification of guidelines or clarifications)?
• What should a new legal framework look like?

Below you will find is a form for your suggestions and ideas and we would be pleased to receive your input before September 11, 2007. Thank you in advance for your collaboration.

Kind regards,

Willem Fibbe
EHA President