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Introduction to GCP
Customised In-house Courses are designed for organisations wishing to train a group of your employees at a location of your choice. For information about online learning click here
Course Information for Introduction to GCP

Duration: 1 or 2 Days

Description:

This course provides a basic working knowledge of GCP.

Who it is suitable for:

This course is aimed at those new to clinical research. The content can be tailored to the function of the audience, for example, CRAs, CTAs, support staff, staff from service providers.

Example content:

Background and history to Clinical Trials legislation

  • Nuremberg Code
  • Declaration of Helsinki
  • Historical context and drivers
  • Development of international GCPs

ICH GCP

  • Background
  • Contents
  • Responsibilities of Ethics Committees, Sponsors and Investigators
  • Essential Documents

FDA 21CFR

  • Background
  • Key differences
  • FDA inspections overview

EU Directives governing clinical research

  • European legal framework
  • Clinical Trials Directive
  • Clinical Trials Guidelines
  • GCP Directive
  • GMP Directive

UK Statutory Instruments (optional)

  • Clinical Trials
  • Human Tissue Act
  • UKECA and NRES

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Previous Course Feedback
A Introduction to GCP Course was delivered for a Pharma Company. The Course had 14 participants. The feedback is shown below.
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Rate the course overall on the scale 10: Excellent, 0: Poor
Average score: 9.9
Participant Feedback :
Great Introduction, just what we needed
Made me see it is more than just GCP
International Sites: UK Europe Asia USA
PharmaSchool Ltd.
t: +44 (0) 845 224 0891 f: +44 (0) 845 224 0873 e: info@PharmaSchool.org