Good Clinical Practice & The Medicines for Human Use (Clinical Trials) Regulations and Amendments (for pharmacy staff)

The EU Clinical Trials Directive (2001/20/EC) was transposed into UK legislation in April 2004 and became effective on the 1st May 2004. The original UK regulations were amended in August 2006 to incorporate the EU Good Clinical Practice Directive (2005/28/EC). The legislation does NOT differentiate between commercial or academic clinical trials.

Online Registration Form

Course Outline

This course will provide an informal but intensive overview of the fundamentals of Good Clinical Practice. The training is based on the principles of GCP and The Medicines for Human Use (Clinical Trials) Regulations SI. 2004/1031 and subsequent amendments, which have transposed the EU Clinical Trials and Good Clinical Practice Directives into UK law.

  • By the end of this course you will:
    • Know what GCP is and how it applies to you
    • Understand the history of GCP and current regulatory requirements
    • Be aware of the principles and conditions of GCP
    • Understand the importance of documentation and good record keeping
    • Understand what an MHRA inspector will look for when visiting a site

Costs:

This course is available for free to all members of KCL, IOP, KCH, Guy’s, St Thomas’ and SLaM staff.

Contact:

For more details or to register, please contact KHP CTO Clinical Trials Training Team.

 

  Dates & Venues:

  • Thursday 7th August
    Meeting room 1, 16th Floor,
    Tower Wing,
    Guy's Hospital:
    10:30-13:00

  • Thursday 3rd September
    Meeting room 1, 16th Floor,
    Tower Wing,
    Guy's Hospital:
    13:30-16:00

  • Friday 10th October
    Meeting room 1, 16th Floor,
    Tower Wing,
    Guy's Hospital:
    13:30-16:00