The EU Clinical Trial Directive

This course focuses on understanding and implementing the requirements of the EU Clinical Trial Directive. The course covers all relevant topics associated with the Directive, and a review of methods for effective implementation. The course consists of lecture and interactive exercises to re-enforce the learning.

Key topics to be discussed:

• The current regulatory situation in relation to clinical trials in the European Union
• The purpose of the new Clinical Trial Directive
• Implementing the EU clinical trial requirements
• The impact the Directive will have on running clinical trials
• The key differences between the EU Clinical Trials Directive, FDA Regulations and ICH Guidelines