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Good Clinical Practice & EU Directive

 

Good Clinical Practice & EU Directive

What
When May 27, 2014 from 09:30 AM to 04:30 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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