EU-Directive 2001/20/EC – Implementation of GCP in the conduct of clinical trials

Oral presentation

After more than 10 years of discussions about the need and content of an harmonized approach to clinical trials in Europe: "Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use“, the "GCP-Directive“, has finally come into force on April 4, 2001. For several aspects the Directive refers to guidelines which will have to be released before May 1, 2003. At this date, the Member States will have to adapt and publish the laws, regulations and administrative provisions necessary to comply with the Directive which will have to come into force at the latest by May 1, 2004. These guidelines have been published as "Drafts“ and publicly discussed, but the final versions will not be released before April 2003.

The GCP-Directive applies to all Phase I to IV trials intended to discover or verify clinical, pharmacokinetic or –dynamic effects of investigational medicinal products and /or to identify any adverse reaction. Non-commercial trials with marketed drugs are covered by the Directive as well. They only can benefit from simplified drug manufacturing requirements, if they deal with indications covered by the marketing authorisation. The Directive does not apply to non-interventional trials.

During the workshop, the content of the Directive and – as far as available – of the related guidelines, will be presented and discussed, especially concerning the impact on study initiation and performance at a clinical site, ethical and safety aspects as well as drug supplies and document handling. In practical exercises first experiences with the guidelines-related forms and processes can be made.

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