The French Pharmacovigilance System
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Regional Pharmacovigilance Centres and AFSSAPS are connected via a national database, which contains adverse drug reac-tions (ADRs) reported by healthcare professionals.
Spontaneous
Reporting - France
THE FRENCH PHARMACOVIGILANCE
SYSTEM
The
French Pharmacovigilance System has a number of features that make it stand
out: it is based upon a network of 31 Regional Pharmacovigilance Centres
(CRPV), co-ordinated by the Pharmacovig-ilance Unit of the French Agency for
the Safety of Health Products (AFSSAPS). Regional Pharmacovigilance Centres
and AFSSAPS are connected via a national database, which contains adverse drug
reac-tions (ADRs) reported by healthcare professionals. All reports are
assessed before entry into the national database, with a common imputability
method. The French organisation is based on a decentralised collec-tion and
validation of safety data through the Regional Pharmacovigilance Centres and a
centralised evalua-tion and decision-making process at the AFSSAPS.
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