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 ofthe leading European regulatory agencies in pharmacovigilance inspections.Besides for-cause-inspections of pharmaceutical companies, the agency conductsapprox. 80 general pharmacovigilance inspections a year with the aim to inspectall U.K. marketing authorisation holders in the near future. That also meansthat companies from other EU member states and third states with a manufacturingsite or sales subsidiary in the U.K. are inspected by MHRA. Qualified Personsfor Pharmacovigilance (QPPV) who might have their office outside the U.K. willbe included in these inspections.

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

The Inspection metrics reports can be found here.
 

Hear John Taylor and Rebecca Harrison fromMHRA speak about Complaint Handling and Pharmacovigilance at the ECAEducation Course Complaint Handling –Pharmacovigilance - Recall in Barcelona, Spain, from 3-4 December2007.

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

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

 

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