Good Clinical Practice

Accredited with 10 ICR* CPD points and 10 FPM** CPD points.

Any organisation conducting a clinical trial on a medicinal product intended for submission to a regulatory organisation is required to follow good clinical practice (GCP) guidelines. Standards must meet the guidelines of the ICH Regulation 6 in the UK and are enforced by the MHRA. Therefore, good clinical practice training is important for anyone involved in clinical research so that your organisation can comply with the industry, and government, good clinical practice guidelines, specifications, and regulations.

This course has a high level overview and is suitable for all personnel within the industry. It has 10 sections covering the following topics:

• Overview/the Purpose of GCP
• ICH Guidelines
• EU & UK Legislation
• Core Principles
• Independent Ethics Committee
• Responsibilties of an Investigator
• Responsibilities of the Sponsor
• Clinical Trial Protocol
• Investigator’s Brochure
• Essential Documentation

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* Institute of Clinical Research
** Faculty of Pharmaceutical Medicine