There are currently four consultations on guidance documents that have been developed in preparation for the implementation of the Clinical Trial Regulation (EU) No 536/2014. The MHRA GCP Inspectorate encourages you to take time to review these.
On 22nd September 2016 the MHRA Inspectorate will be holding another GLP and GCP Laboratories Symposium.
...data integrity challenges facing industry and regulators. But we haven’t stopped there. “MHRA has produced draft GxP data integrity guidance for industry and we welcome your comments” Revision of data...
As with most activities in clinical trials, the development of electronic systems is playing an increasing role in methods for data collection. As inspectors we are therefore continually seeing new systems while out and about on inspection, and adapting our …
The Medicines and Healthcare products Regulatory Agency (MHRA) UK is honoured to be the host of the 2016 PIC/S Seminar. This is an annual international event attended by both member and non-member authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). …
A year ago today we launched the MHRA Inspectorate blog. Now, after 12 months of activity it’s a good time to reflect on where we are and what’s to come.
We are aware there is some concern for UK business and personal careers, over the status of transitional QPs that were recognised under the transitional arrangements provided in SI 2004/1031, when the Clinical Trials Directive was implemented in 2004. The …
In October 2015 a number of MHRA GCP Inspectors attended the GCP Inspectors Working Group Workshop hosted by the European Medicines Agency (EMA) in London. This is an annual training event originally held for EU Good Clinical Practice (GCP) Inspectors that …
My name is Balall Naeem and I have been with the MHRA for more than 10 years now. In that time, I have worked across 3 different Divisions in a number of roles. The ones most relevant for this topic would …
We are aware there is some concern for UK business and personal careers, over the status of transitional QPs that were recognised under the transitional arrangements provided in SI 2004/1031, when the Clinical Trials Directive was implemented in 2004. The …
