Introduction to GCP
Categories: Pharmaceutical
Understand the significance of Good Clinical Practice (GCP) and it’s ever increasing importance within clinical research, and also the impact of the EU Clinical Trials Directive.

What Is The Course About?
This course is suitable for everyone who is new to the industry or is working in a support role. It has particular relevance to CTAs and support staff working alongside CRAs or Project Managers.

By the end of the course, you will be able to:
- Understand why GCP was created including the history and current initiatives
- Understand the implementation, importance and effects of GCP and why the guidelines are
as they are today.
- Understand the importance of your own role within the clinical trial process
- Have an appreciation of the issues that affect the successful development of new products.

The full fee for this course is £590 +vat and includes full course materials, lunch and refreshments.
Course Programme:
Introduction to GCP
The Clinical Research Process
Background & History of GCP
- ICH and the EU Directive on GCP in Clinical Trials
Protection of the Subject in Research
- Ethics Committees and Informed Consent
Essential Documents
- ICH Section 8
- FDA Documentation
Audit & Inspection
- Quality Issues
Responsibility of the Investigator / Monitor
- ICH requirements
 
Course Dates
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The course either has new dates in data loading, or is only run as a dedicated or In Company course.
Tools
 
Key Details
Duration1 day
 
£590
per delegate