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:
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.