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Blog MHRA Inspectorate

Organisations:
Medicines and Healthcare products Regulatory Agency
MHRA Inspectorate

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

Posted by: , Posted on: - Categories: Compliance matters, Events and symposia, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate
PIC/S Seminar Delegates

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

Posted by: , Posted on: - Categories: Compliance matters, Events and symposia, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate
PIC/S 2016 Logo

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

Posted by: , Posted on: - Categories: 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
Birthday cake with one lit candle

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.

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

Posted by: , Posted on: - Categories: Compliance matters, Events and symposia, Good pharmacovigilance practice, Inside the Inspectorate
EU Inspector Training: GPvP Inspectors from the MHRA, EU and beyond and EMA staff who coordinated the event.

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

Posted by: , Posted on: - Categories: Compliance matters, Events and symposia, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate
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 …

Supply of unlicensed medicines when an equivalent licensed product becomes available

Posted by: , Posted on: - Categories: Compliance matters, Good distribution practice, Good manufacturing practice
blister pack

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

Posted by: , Posted on: - Categories: 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

Posted by: , Posted on: - Categories: Compliance matters, Good distribution practice, Good manufacturing practice
Tablets in many colours

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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