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
Who Should Attend
This two-day training course will be of value to clinical research professionals conducting clinical studies in the European Union either as stand alone trials or as part of a multi-national clinical study program.
The course is designed to benefit the following disciplines:
- Clinical operations staff conducting trials with drugs, biologics or combination products
- Quality Assurance (GCP Auditors)
- Regulatory Affairs
- Clinical trial supply
- All personnel who need to understand the impact of the EU Clinical Trial Directive (e.g. project management, study site staff, CRO personnel, etc.)
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
Frequently Asked Questions
Does this course discuss the differences between 21 FFR and the EU Directive?
Yes, The focus of this course is the European Clinical Trials Directive. However, this course discusses the similarities and differences between the Directive and the US Code of Federal Regulations.
Are the proposed changes to the Directive discussed?
Yes, the proposed changes to the current Directive are discussed. The rationale for these changes is also discussed.