Clinical Trials Regulations
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Clinical Trials Regulations

Course Contents
- Overview of the framework of clinical trial regulations in Europe
- EU Clinical Trials Directive and some of the key issues
- The GCP directive
- Non-commercial Guideline
- Clinical trial authorisation
- Clinical trial regulation
- Authorisation and amendments
- Running clinical trials in children
- Legal aspects of clinical trials
- Investigational Medicinal Product
- Pharmacovigilance and adverse event reporting
- Clinical trial data management including EDC and E-Source
- Other recent developments in clinical trial regulations
- FDA recent developments
- Regulatory inspection

Course Duration:
2 days
 
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Key Details
Duration2 days
 
£1,290
per delegate
 
 
Bookings Helpline: 01933 233884 (Monday to Thursday - 8:00am to 5:30pm and Friday 8:00am to 5:00pm).