151,069 members

Skip to content. | Skip to navigation


Good Clinical Practice & The EU Directive


Good Clinical Practice & The EU Directive

When Mar 19, 2014 from 09:30 AM to 04:40 PM
Where Edinburgh
Add event to calendar vCal

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

More information about this event…