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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.
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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) |
