Course Description

The adoption of Council Directive 2001/20/EC means that: All clinical trial materials must be made in accordance with the principles of GMP - Manufacturing facilities must hold an appropriate authorisation and will be subject to inspection by the regulatory authorities - All investigational medicinal products must be subject to certification by a Qualified Person prior to release into a trial. This course is designed to provide existing, trainee and transitional Qualified Persons with the foundation knowledge and understanding required to assess and certify investigational medicinal products and to appreciate the fundamental differences between IMPs and licensed products. It will also be of value for other technical staff working with clinical trial supplies.

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