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This course provides an in-depth look at the regulatory systems currently in operation in the EU and their impact, together with UK legislation, on the conduct of clinical research. Starting with a refresher on the history of medicinal product regulations and the need for ethics, the course explains in more detail the practical applications of GCP and outlines recent major developments in GCP.

Delegates will receive a complimentary copy of the ICH GCP guidelines and a workbook.

• Outline recent major developments in Good Clinical Practice

• Discuss the purpose and impact of EU regulations on the conduct of clinical research

•Outline the proposed Clinical Trial Regulation

• Summarise other current issues that affect clinical trials

e.g. risk based monitoring