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Good clinical practice

2015 EU GCP Inspectors Electronic Data Integrity Workshop

Posted by: , Posted on: - Categories: Events and symposia, Good clinical practice, Inside the Inspectorate
Inspectors Working Group at the EMA

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 …

Transitional QPs for investigational medicinal products (IMPs)

Posted by: , Posted on: - Categories: Compliance matters, Good clinical practice, Good manufacturing practice
QP using laptop in office

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 …

PIC/S - Press release and news of MHRA chair in 2016/17

Attendees at the 2015 PIC/S Annual Seminar, Indonesia

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 …

Helping us to help you – 5 top tips for making enquiries to the MHRA Inspectorate

Helping us to help you by a) check our blog/pages of the website, b) be specific by which GXP your query relates to c) be specific about what your query relates to d) be specific about which company/site your query relates to e) give your proposal of what you intend to do

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 …

Educating and engaging through our symposia

Good Clinical Practice Symposium

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 …