The French pharmacovigilance system: structure and missions
Welsch, M.; Alt, M.; Richard, M.H.; Imbs, J.L.
Presse Medicale 29(2): 102-106
2000
ISSN/ISBN: 0755-4982 PMID: 10682040 Document Number: 517567
THE NETWORK: The French pharmacovigilance system is composed of a network of 31 regional pharmacovigilance centers located in convenient proximity to health care professionals. CAUSALITY ASSESSMENT: A causality assessment method is compulsory for all persons involved in pharmacovigilance in order to assess the causal relationship between an adverse effect and one or more drugs. PHARMACOEPIDEMIOLOGY: If necessary, an additional evaluation of the causal relationship is performed using pharmacoepidemiology methods. THE NATIONAL COMMISSION: A technical committee and a National Commission of Pharmacovigilance centralizes at the Agence Françiase de Sécurité Sanitaire (or AFSSAPS) and assesses all data in order to provide consensual advise to the relevant authorities on necessary measures, to prevent or reduce a drug-related adverse effect.