Abstract
Internationally, in the development of new pharmaceuticals, there is a clear trend to improve quality of clinical trials. Improved methods which have an impact on quality can be observed at the interface of good manufacturing practices (GMP) and good clinical practices (GCP), concerning the production and packaging of clinical trial supplies. The WHO, FDA and the EC health authorities are currently considering the need for guidelines for clinical trial supplies. This two-day workshop focused on the issues surrounding the innovative application of GMP and GCP to clinical trial supplies and on filling the gap between GMP and GCP.
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