8. Conclusion
Pharmacovigilance data contribute to the ongoing reassessment of the risk/benefit ratio of drugs in real-life prescribing situations. On an individual level, it helps to choose the best drug for a given patient; on a population level, it leads to the decision whether or not to keep a drug on the market, or to inform healthcare professionals and the public of the potential risk.
Pharmacovigilance is more than just a monitoring activity. It is part of a wider process of preventing and assessing drug risk in the day-to-day practice of healthcare professionals. It is an integral part of quality and risk management processes. The development of epidemiological studies, as a complement to existing vigilance systems and the active search for signals, provides a global view of the real-life safety profile of drugs.
According to Prescrire, public...
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Conclusion
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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