Good clinical practice
The GMP Inspectorate works closely with the Clinical Trials Unit (CTU) at MHRA and regularly provides support to help answer a wide range of stakeholder queries which relate to the manufacture, import, labelling, licensing requirements and general handling of Investigational …
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 …
Happy New Year! Having pestered my team for ideas for the blog and articles it seems only fair I start 2016 by writing one myself, with a focus on stakeholder engagement and the new EU Clinical Trials Regulation update. My …
Back in October I attended, with MHRA colleagues, the PIC/S (Pharmaceutical Inspection Co-operation Scheme) committee meeting and annual seminar that was this year hosted by the Indonesian National Agency for Drug and Food Control (NADFC). In the new year I'll …
The MHRA Inspectorate receives several hundred enquiries via email each year. Answering queries is one of the key ways we support industry. It provides reassurance to our stakeholders, aiding them in their decision-making processes, helping to ensure they don’t fall …
The trial master file (TMF) is the collection of essential documents which allows the conduct of a clinical trial to be reconstructed and evaluated. It is basically the story of how the trial was conducted and managed. This blog highlights …
A highlight of our work is when we get to engage with you through our symposia. It is a rewarding opportunity for us to keep many hundreds of you – our stakeholders - up to date with the latest regulatory …
