The EU Clinical Trial Directive

Learning Objectives

Upon completion of this course you will have a working knowledge of the EU Clinical Trial Directive requirements.
 
This course is designed to provide attendees with:

• The latest information regarding the interpretation and enforcement of these regulations
• An understanding of how to implement and be compliant with the Directive
• An understanding of how the EU Clinical Trial Directive differs from the US FDA Regulations and ICH Guidelines

Course Description

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