Clinical Training 2011 - Critical Compliance and Major Changes for the EU Clinical Trials Directive

This EU Clinical Trials Directive training will cover major changes to compliance requirements concerning the Clinical Trial Directive that you should know to get your trial approved or run clinical trials to meet EU requirements.

This presentation will discuss the key requirements of the European Clinical Trials Directive 2001/20/EC and the important proposed changes.

This presentation will explain the framework of documents, provided in the Clinical Trials Directive, which sets out how clinical trials must be conducted. We will discuss how the Directive was further expanded by Commission Directive 2005/28/EC of laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products" (Good Clinical Practice - " the GCP Directive").