The MHRA pharmacovigilance inspection metrics for the period from April 2017 to March 2018 are now available on GOV.UK
The first of two posts focusing on sponsor oversight and how to improve compliance in this area.
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.
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.
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.
Find out how to register for the 2018 GCP Symposium.
Guidance and examples of data integrity issues seen on GDP inspections.
The GDP Inspectorate are currently recruiting, find out more about the role and how to apply.
From 16 to 18 April 2018 the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.
The GDP inspectorate has seen a growing number of false NHS and private prescriptions being used to obtain medicines from Marketing Authorisation Holders for the onward wholesale.
This post provides guidance around the use of VHP for sterilization purposes
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