While publication of the Clinical Trial Database is delayed, the endorsement of the Clinical Trial Regulation is moving forward in other areas. The Clinical Trial Regulation Conference will focus on the differences between, the present and new requirements on managing clinical trials in the face of forthcoming changes.

This 2-day conference will provide a forum for information exchange on both conceptual and practical questions of:

• How will the new legislation change the processes and the format of the trial application?
• What are the impacts on how a clinical trial is managed after approval has been granted?
• What are the critical issues affecting sponsors and Member States as they consider changes needed to implement the regulation?
• How will the new provisions for public access to an EU Clinical Trials Database enforce disclosure of clinical trial data and information?

Attendees will participate in the collaborative discussions through lectures, panel discussions and interactive sessions.