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The International Regulatory Affairs Network

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The EU Clinical Trial Directive

26.04.2010 - 27.04.2010
Ort: Berlin, Germany

This course focuses on understanding the requirements of the new EU Clinical Trial Directive and the issues inherent in any new regulatory process.
This course focuses on understanding the requirements of the new EU Clinical Trial Directive and the issues inherent in any new regulatory process. The course covers all relevant topics associated with the Directive, the reasons behind its introduction, and a review of methods for effective implementation. Topics to be discussed include the key differences between ICH, GCP and the new EU Directive, understanding the impact of the directive, and how to meet its regulatory and ethical requirements.

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