6. Signal detection and evaluation
Based on the analysis of data collected on ARs, particularly in terms of severity, novelty and frequency, ANSM must be alerted to a potential signal that could modify the benefit/risk ratio of the drug. If the signal is confirmed, thus becoming an alert, precautionary measures and/or preventive or corrective actions must be implemented.
6.1 Signal detection
Signal detection in pharmacovigilance involves highlighting any potential association between a drug and the AEs it is likely to cause, where this relationship is unknown or insufficiently documented. The signal may reveal a new iatrogenic effect of the drug, but also risk factors for its occurrence, drug interactions and so on.
Signals can be detected manually, by analyzing notifications...
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Signal detection and evaluation
Regulatory measures to control risk
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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 ...
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