Mark Birse

Former Deputy Director of the Inspection, Enforcement and Standards Division and Head of the MHRA Inspectorate & Process Licencing which employs over 75 Inspectors covering GCP, GDP, GLP, GMP & GPvP and the Process Licencing team

Group Manager of MHRA Devices Safety and Surveillance Group & Devices Software and Apps Group.

Joined the MHRA in 2002 as a GMP Inspector having previously worked in the pharmaceutical industry for over 10 years.

https://www.linkedin.com/in/markbirse/

PIC/S - Press release and news of MHRA hosted meetings and seminar, July 2016

Mark Birse, 1 August 2016 - Compliance matters, Events and symposia, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate

Just 4 weeks ago the MHRA hosted the PIC/S Committee meeting, PIC/S Executive Bureau meeting, and PIC/S Annual Seminar at the Museum of Science and Industry (MOSI) in Manchester.

PIC/S 2016 - Manchester

Mark Birse, 28 June 2016 - Compliance matters, Events and symposia, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate

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). …

1st birthday - reflections on the last year of blogging

Mark Birse, 23 June 2016 - Compliance matters, Events and symposia, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate, Wider MHRA

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.

Blogging matters

Mark Birse, 16 May 2016 - Events and symposia, Inside the Inspectorate

'Blogging is awful, but also amazing'.  That was just one of the take home messages from The Guardian's Stuart Heritage at last week's #GovBlogCamp.

Enforcement Group - tackling the illegal trade in medicines

Mark Birse, 13 May 2016 - Compliance matters, Wider MHRA

https://youtu.be/HdHMO0a_p6s

Last week, our colleagues from the agency’s Enforcement team, along with the National Crime Agency, conducted one of their biggest-ever operations to take down unlicensed erectile dysfunction medicines.

The GPvP inspectorate promote compliance and best practice at 2 successful events

Mark Birse, 1 February 2016 - Compliance matters, Events and symposia, Good pharmacovigilance practice, Inside the Inspectorate

Late last year the GPvP inspectorate ran its own symposium and contributed heavily to the EU pharmacovigilance inspector training event. GPvP symposium The GPvP inspectorate held a sell-out symposium in London in November attended by approximately 350 delegates. GPvP inspectors highlighted requirements, …

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 …

Supply of unlicensed medicines when an equivalent licensed product becomes available

Mark Birse, 9 October 2015 - Compliance matters, Good distribution practice, Good manufacturing practice

We've had a number of instances where licensed versions of commonly supplied unlicensed medicines have become available.  We want to remind stakeholders what to do if this happens. Recent examples of newly licensed products of this nature include fomicyt, 40mg/ml fosfomycin …

The British Pharmacopoeia's new website - setting the standards

Mark Birse, 14 August 2015 - Compliance matters, Good manufacturing practice, Inside the Inspectorate, Wider MHRA

The launch of the new integrated British Pharmacopoeia website this week presents a great opportunity to explore this other group within the Inspection, Enforcement & Standards Division of MHRA. The British Pharmacopoeia (BP) makes an important contribution to the role of MHRA …

Importation of unlicensed medicines and centrally authorised products - a helpful reminder

Mark Birse, 23 July 2015 - Compliance matters, Good distribution practice, Good manufacturing practice

We have recently had a number of situation where importers of unlicensed medicines have attempted to notify MHRA of centrally authorised products for import as unlicensed medicines. This is not appropriate, as these are not unlicensed medicines and should be distributed …

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This blog shares the work of the Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate, by inspectors and those the Inspectorate works with.

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Recent posts

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• Pharmacovigilance unravelled: highlights of the 2024 MHRA GPvP Symposium
• Pilot GMP Single Inspection Program