4. Post-AMM risk monitoring methods
4.1 Spontaneous notification
Spontaneous reporting of adverse drug reactions is the cornerstone of any health alert system.
Spontaneous reporting refers to the transmission of an AR case by an observer to a pharmacovigilance structure. In France, the observer is usually a doctor, and the structure is an independent organization such as the Regional Pharmacovigilance Centers (CRPV).
The notification includes...
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Post-AMM risk monitoring methods
The role of the various parties involved
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