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Good Clinical Practice & The EU Directive

 

Good Clinical Practice & The EU Directive

What
When Mar 19, 2014 from 09:30 AM to 04:40 PM
Where Edinburgh
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Through a  mixture of lectures and workshops this course:

 

•Provides a history of clinical trials and the development of GCP

•Deciding what is a clinical trial as per EU Directive discussion of informed consent - the ethical and statutory imperatives with particular reference to vulnerable groups

•Responsibilities of research personnel and the process for obtaining approvals to conduct clinical trials

•Overview of the 14 principles of GCP

•Pharmacovigilance - definitions and a series of case studies are discussed

•'Monitoring' exercise - group exercise to highlight examples of breaches of GCP and documentation discrepancies that can occur

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