Good clinical practice

Sponsor Oversight- Part 1

Posted by: Mandy Budwal-Jagait, Posted on: 26 July 2018 - Categories: Compliance matters, Good clinical practice

The first of two posts focusing on sponsor oversight and how to improve compliance in this area.

GCP Symposium 2018

Posted by: Mandy Budwal-Jagait, Posted on: 31 May 2018 - Categories: Compliance matters, Events and symposia, Good clinical practice

Find out how to register for the 2018 GCP Symposium.

PIC/S press release following April 2018 meeting

Posted by: Mark Birse, Posted on: 9 May 2018 - Categories: Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate

From 16 to 18 April 2018 the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.

MHRA’s GXP data integrity guide published

Posted by: Tracy Moore, Posted on: 9 March 2018 - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice

The MHRA’s GXP data integrity guide has been published today.

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)