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/
Our GDP inspectors often receive queries from wholesaler distributors asking in what instances agreements are required for the purposes of fulfilling pharmacovigilance requirements.
Last week we published the 1st April 2015 to 31st March 2016 GCP Inspection metrics report.
We have today updated the sidebar of the MHRA Inspectorate Blog to provide access to the MHRA Inspectorate organogram.
Earlier this week we published the 2016 GMP inspection deficiency data trend.
In the coming weeks, you will notice that it’s much quieter than usual on the MHRA Inspectorate blog. It’s because between midnight on Friday, 21 April and the general election on 8 June is the pre-election period.
From 10 April, we are removing .gsi from our email addresses. Technology has changed a lot since the introduction of the Government Secure Intranet (GSi) in 1996
Previously, we have reminded importers of unlicensed medicines that Centrally Authorised medicines are the subject of Marketing Authorisations from the EMA, valid in all Member States and therefore cannot be notified for import into the UK as unlicensed medicines, unless …
From 8 to 10 February 2017, the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland
The 2015 GMP inspection deficiency data trend has been published yesterday
The 2017 Orange and Green Guides are almost ready for publication.
