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.
Good pharmacovigilance practice
The MHRA pharmacovigilance inspection metrics for the period from April 2017 to March 2018 are now available on GOV.UK
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 Process Licensing Office has today joined the Inspectorate to become the Inspectorate & Process Licensing Group.
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.
From 16 to 18 April 2018 the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.
The MHRA’s GXP data integrity guide has been published today.
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.
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.
Whilst we progress our latest recruitment campaign for GMDP Inspectors, Ian Holloway reflects on 30 years of working for the Medicines Regulator.