Good clinical practice

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

Mark Birse, 25 November 2015 - Compliance matters, Events and symposia, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate

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

Chris Gray, 19 November 2015 - Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate

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 …

Inspecting clinical trials - The trial master file

Gail Francis, 30 July 2015 - Compliance matters, Good clinical practice

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 …

Educating and engaging through our symposia

Mark Birse, 7 July 2015 - Events and symposia, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice

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 …

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