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.
The stakeholders represent trade organisations such as ABPI, RQA, BIA, EFGCP and also non-commercial organisations such as MRC, NIHR, NHS R&D Forum and UKCRN. Representatives from the Health Research Authority, CQC, Department of Health and the devolved nations also attend. We would encourage you to talk to your representative and discuss these issues so your views can also be heard at the meeting.
Invitations will be send out imminently to the stakeholder representatives.
If you are unclear whether your professional organisation is represented and you feel it should be, please contact us at clintrialhelpline@mhra.gov.uk
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