European Companies and QPPVs in the Focus of U.K. Pharmacovigilance Inspections

GMP News
15 November 2007
 

European Companies and QPPVs in the Focus of U.K.
Pharmacovigilance Inspections


The British Medicines and Healthcare Products Regulatory Agency (MHRA) is one of the leading European regulatory agencies in pharmacovigilance inspections. Besides for-cause-inspections of pharmaceutical companies, the agency conducts approx. 80 general pharmacovigilance inspections a year with the aim to inspect all U.K. marketing authorisation holders in the near future. That also means that companies from other EU member states and third states with a manufacturing site or sales subsidiary in the U.K. are inspected by MHRA. Qualified Persons for Pharmacovigilance (QPPV) who might have their office outside the U.K. will be included in these inspections.

The MHRA has published frequently asked questions for Good Pharmacovigilance Practice on their website.

The Inspection metrics reports can be found here.
 

Hear John Taylor and Rebecca Harrison from MHRA speak about Complaint Handling and Pharmacovigilance at the ECA Education Course Complaint Handling – Pharmacovigilance - Recall in Barcelona, Spain, from 3-4 December 2007.

Experts from the pharmaceutical industry will share their expert knowledge about all relevant aspects regarding the current expectations.

Author:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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