Today marks the start of the operational phase of the EU-FDA mutual recognition agreement
I am the Deputy Director of the Inspection, Enforcement and Standards Division and Head of the MHRA Inspectorate which employs over 75 Inspectors covering GCP, GDP, GLP, GMP & GPvP.
I joined the MHRA in 2002 having previously worked in the pharmaceutical industry for over 10 years.
The MHRA has seen an increasing number of inspections being conducted in both the UK and the rest of the EU by regulators from other countries.
From 11 to 15 September 2017 I attended the PIC/S Committee meeting, Executive Bureau meeting, and Annual Seminar hosted by the Taiwan Food and Drug Administration (TFDA)
A bite sized summary of our recent posting to the MHRA Inspectorate blog
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