Compliance matters

National and International GCP Symposia

Posted by: Paula Walker, Posted on: 10 September 2018 - Categories: Compliance matters, Events and symposia, Good clinical practice

On the 5 and 6 September, the GCP Inspectorate held their symposium and were joined by colleagues from the FDA, the Brazilian authority ANVISA and the Israeli Ministry of Health.

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.

The Responsible Person named on the WDA- Part 3: Expectations for the engagement of consultants as contract RPs

Posted by: Madeleine Ault and Peter Brown, Posted on: 8 August 2018 - Categories: Compliance matters, Good distribution practice

This is the final of three posts centered around the Responsible Person named on a Wholesale Distribution Authorisation (WDA) and covers the engagement of a contract RP

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.

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.

The Responsible Person named on the WDA -Part 2: Effective Appointment and Training

Posted by: Madeleine Ault, Posted on: 13 July 2018 - Categories: Compliance matters, Good distribution practice

This is the second in a set of three posts centred around the Responsible Person named on a Wholesale Distribution Authorisation (WDA). This post has been written to enhance the appointment of the RP.

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.

The Responsible Person named on the WDA. Part 1: Raising the profile of the RP

Posted by: Madeleine Ault and Peter Brown, Posted on: 15 June 2018 - Categories: Compliance matters, Good distribution practice

This is the first in a set of three posts centered around the RP named on a WDA. This post provides information on external training recognition and training providers. The second of these three posts aim to enhance the appointment of the RP and the third post will place a particular emphasis on the engagement of a contract/consultant RP.