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 half-day 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
    • Share best research practice with other members of pharmacy

Costs:

This course is available for KCL, IOP, KCH, Guy’s, St Thomas’ and SLaM staff. This training is supported by the King's Health Partners Clinical Trials Office (Kings Health Partners CTO); therefore there is no charge to delegates.

Contact:

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

To register, please provide the following information:

  • Course Date
  • Name
  • Job Title
  • Department
  • Organisation
  • Telephone
  • Email
  

  Dates & Venues:

  • 15th August 2013
    Social, Genetic and Developmental Psychiatry Centre,
    Seminar Rooms A&B (ground floor)
    Denmark Hill Campus:
    12:00 - 16:00

  • 5th September 2013
    CRF Meeting Room, 15th Floor Tower Wing
    Guy's Hospital
    10:00 - 12:30

  • 4th October 2013
    CRF Meeting Room, 15th Floor Tower Wing
    Guy's Hospital
    10:00 - 12:30