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...
Exclusive to subscribers. 97% yet to be discovered!
Already subscribed? Log in!
Signal detection and evaluation
Regulatory measures to control risk
Bibliography
Exclusive to subscribers. 97% yet to be discovered!
Already subscribed? Log in!
Article included in this offer
"Drugs and pharmaceuticals"
(
130 articles
)
Updated and enriched with articles validated by our scientific committees
A set of exclusive tools to complement the resources
