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- W2038866728 abstract "La France a progressivement mis en place un système national de pharmacovigilance qui comprend 31 centres régionaux (CRP) coordonnés par une agence centralisatrice qui a également autorité sur les titulaires d'autorisation de mise sur le marché (AMM). Les professionnels de santé ont l'obligation légale de signaler aux CRP les événements graves dont ils ont connaissance. Ces informations sont saisies dans une banque nationale après validation par les CRP. Elle sert à l'évaluation permanente de la iatrogénie médicamenteuse, et elle constitue, avec les données des banques privées des titulaires d'AMM, le matériel à partir duquel seront prises les décisions de modification d'AMM en cas de problème de santé publique. Des liens de fonctionnement existent entre CRP, agence et titulaires d'AMM. Les CRP, proches des professionnels de santé hospitaliers, réalisent également des enquêtes prospectives qui permettent de préciser la prévalence des effets indésirables en France et d'apporter des éléments de réflexion pour la diminuer. The French Pharmacovigilance System is based on a network of 31 Regional Centres of Pharmacovigilance (RCP) which receive Adverse Drug Reaction reports from Health Professionals. They are coordinated by the French Agency within which resides regulatory authority. All cases reported are entered into a single database after having been evaluated for causality by the RCP. There are regulatory relationships between the RCP, the French Agency and the Marketing Autorisation Application Holders (MAH). If a problem of tolerance imperils public health, measures are taken on the basis of the informations provided by the national database and the database of the MAH. The RCP network also performs prospective studies in order to evaluate the prevalence of Adverse Drug Reactions mainly in university hospitals. Such studies are helpful to manage and avoid drug-related disorders." @default.
- W2038866728 created "2016-06-24" @default.
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- W2038866728 date "2001-02-01" @default.
- W2038866728 modified "2023-10-18" @default.
- W2038866728 title "La pharmacovigilance I. Structure et activités du système français" @default.
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- W2038866728 doi "https://doi.org/10.1016/s0338-9898(01)80091-3" @default.
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