Good pharmacovigilance practice

It pays to be compliant!

In a bid to drive improved compliance and to cover the cost of managing more resource-intensive cases, the Inspectorate intends to apply the existing office-based assessment fee more broadly.

Pharmacovigilance Inspection Metrics April 2017 to March 2018

Posted by: Anna Adams, Posted on: 4 December 2018 - Categories: Good pharmacovigilance practice

The MHRA pharmacovigilance inspection metrics for the period from April 2017 to March 2018 are now available on GOV.UK

What to expect from GPvP inspections

Posted by: Anna Adams, Posted on: 17 August 2018 - Categories: Compliance matters, Good pharmacovigilance practice

The GPvP webpage has recently been updated to provide additional information about the current inspection process. This post provides some further information about GPvP inspectors and inspections.

Process Licensing Office joins the Inspectorate

Posted by: Mark Birse, Posted on: 1 August 2018 - Categories: Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate

The Process Licensing Office has today joined the Inspectorate to become the Inspectorate & Process Licensing Group.

MHRA Pharmacovigilance Symposium 2018

Posted by: Mandeep Rai, Posted on: 5 July 2018 - Categories: Compliance matters, Events and symposia, Good pharmacovigilance practice

In may, the GPvP Inspectorate held their symposium, which provided a platform for information sharing and discussion between inspectors and assessors from the MHRA and industry colleagues working within pharmacovigilance and associated departments.

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.

MHRA Pharmacovigilance Symposium 2018

Posted by: clairelongman, Posted on: 23 February 2018 - Categories: Compliance matters, Events and symposia, Good pharmacovigilance practice

Find out here how to register for the 2018 pharmacovigilence symposium which will include topics such as inspection findings and trends, a talk on service providers and outsourcing and areas of change such as signal detection in Eudravigilance.

MHRA GPvP Inspectorate Guide to Marketing Authorisation Holder Considerations for Agreements with Pharmacovigilance System Service Providers

Posted by: joannaharper, Posted on: 22 January 2018 - Categories: Compliance matters, Good pharmacovigilance practice

The pharmacovigilance systems of marketing authorisation holders are often dependent on multiple third parties; extensive outsourcing and partnering is a feature of the pharmaceutical industry as much as any other. This blog expands upon the areas identified as problematic for MAHs and service providers and provides points to consider when producing contracts and agreements text.