Today marks the start of the operational phase of the EU-FDA mutual recognition agreement
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)
The MHRA are holding a GCP Stakeholder engagement meeting on 16th November at our offices in London in order to explore 3 areas of the new Clinical Trials Regulation that require national legislation.
A bite sized summary of our recent posting to the MHRA Inspectorate blog
In part 2 of our series on QP Certification and Batch Release we concentrate on the application of Annex 16 to Investigational Medicinal Products (IMPs)
Last week we published the 1st April 2015 to 31st March 2016 GCP Inspection metrics report.
This post focuses on Computer System Validation (CSV) and is a combination of a case study seen at a single organisation and some of the common findings GCP Inspectors have seen across a number of recent inspections.
The first post in this series described the importance of organisational behaviour on the success of data integrity control measures. Behavioural issues are often unsuitable for technical guidance, but the Inspectorate blog provides an opportunity to address this complex issue.
From 8 to 10 February 2017, the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland
