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Good Clinical Practice & The EU Directive


Good Clinical Practice & The EU Directive

When Jan 22, 2014 from 09:35 AM to 04:35 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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