• By ICR Secretariat
  • Posted Monday, September 25, 2017

MHRA- Upcoming GCP stakeholder engagement meeting

https://mhrainspectorate.blog.gov.uk/2017/09/21/upcoming-gcp-stakeholder-engagement-meeting/

The MHRA are holding a GCP Stakeholder engagement meeting on 16th November at our offices in London in order to explore 3 areas of the new Clinical Trials Regulation that require national legislation.

Those areas are:

  • Who can take consent,
  • Who can be an investigator
  • Arrangements for exemption of GMP for hospitals and health centres

These are areas that have not been reviewed for many years. Clinical practice has evolved since the implementation of the Clinical Trial Directive in 2004, therefore a review of how these areas are regulated is warranted.

The MHRA GCP Stakeholder Engagement Meeting provides a forum for consultation and discussion around GCP and provides updates on operational, national and international regulatory matters. The format of the upcoming meeting will be a little different as we want our members to divide into groups to discuss these 3 areas in detail and provide feedback on current thoughts and opinions; therefore, this will be a listening exercise for MHRA that will be used to inform our national legislation.

For more information, or to ask any questions, please follow the link above.