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1. Structuring pharmacovigilance
Caregivers have always been concerned to avoid iatrogenic medication in their patients. Hippocrates' primum non nocere has always been the rule. However, awareness of the risk of serious adverse drug reactions (ADRs) arose quite recently and brutally with the thalidomide tragedy, a drug presumed harmless in the early days of its use. Ten years later, the sad experience of diethylstilbestrol showed that systematic and prolonged drug monitoring is necessary to assess the risk profile of drugs.
1.1 Lessons from thalidomide and...
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Structuring pharmacovigilance
Definitions
Bibliography
- (1) - BLAYAC (J.P.) - Regard historique sur la mise en place de la première vigilance française : la pharmacovigilance. - Académie des Sciences et Lettres de Montpellier, 8 fév. 2010 http://www.ac-sciences-lettres-montpellier.fr/academie_edition/fichiers_conf/BLAYAC-2010.pdf ...
Websites
http://ansm.sante.fr/ (page consulted on November 26, 2015)
https://ansm.sante.fr/documents/reference/declarer-un-effet-indesirable
Regulations
Laws
Law no. 2011-2012 of December 29, 2011 on reinforcing the safety of medicines and health products
Law no. 98-535 of July 1 1998 on the reinforcement of health monitoring and control of the safety of products intended for human use.
Law no. 95-116 of February 4, 1995 on various social provisions
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