To ensure clinical trials meet the requirements of the regulatory authorities it is essential that trials are carried out to the latest good clinical practice (GCP) regulatory requirements. It is particularly important to keep up-to-date and be familiar with the recent developments in GCP, and also how these are likely to impact on trials in the future for both pharmaceutical companies and the study sites. Regulatory inspectors expect those involved in clinical trials to be updated with recent developments in GCP – this workshop will be ideal for this. This very informative workshop will take you through the most important recent developments which are having an impact on clinical trials. Topics include an update on the latest CT Directive guidelines and other EU GCP developments, and recent initiatives in the U.S. that are having an impact in Europe. There will be plenty of time for group discussion of your issues so as to help you develop you strategies for managing these changes.
GCP Update: Review of the Latest Requirements in Europe and U.S.
Apr 28th, 2008
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