Good clinical practice

Looking for a New Challenge in 2018?

Posted by: Mark Birse, Posted on: 21 December 2017 - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate, Wider MHRA

Whilst we progress our latest recruitment campaign for GMDP Inspectors, Ian Holloway reflects on 30 years of working for the Medicines Regulator.

Risk Adaption in Clinical Trials of Investigational Medicinal Products (CTIMPs)

Posted by: Kath Meely, Posted on: 16 November 2017 - Categories: Compliance matters, Good clinical practice

MHRA are actively promoting a risk proportionate approach to CTIMPs

2018 MHRA Laboratories Symposium

Posted by: Lynsay Hunter, Posted on: 3 November 2017 - Categories: Compliance matters, Events and symposia, Good clinical practice, Good laboratory practice, Good manufacturing practice

The Inspectorate laboratories group conducts a diverse number of inspections both internationally and across the United Kingdom.

EU-FDA mutual recognition of inspections of medicines manufacturers enters operational phase

Posted by: Ian Rees and Mark Birse, Posted on: 1 November 2017 - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice

Today marks the start of the operational phase of the EU-FDA mutual recognition agreement

International regulators inspecting in the UK

Posted by: Mark Birse, Posted on: 19 October 2017 - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice

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.

PIC/S - Press release and news of TFDA hosted meetings and seminar, September 2017

Posted by: Mark Birse, Posted on: 11 October 2017 - Categories: Compliance matters, Events and symposia, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice

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)

Upcoming GCP stakeholder engagement meeting

Posted by: Gail Francis, Posted on: 21 September 2017 - Categories: Compliance matters, Good clinical practice

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.

Missed our last few posts?

Posted by: Mark Birse, Posted on: 1 September 2017 - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice

A bite sized summary of our recent posting to the MHRA Inspectorate blog

Annex 16 QP Certification and Batch Release – Frequently Asked Questions – part 2

Posted by: Alan Moon and Trevor Watson, Posted on: 14 August 2017 - Categories: Compliance matters, Good clinical practice, Good manufacturing practice

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)