Post-AMM risk monitoring methods
Pharmacovigilance- Adverse drug reaction monitoring
Article REF: PHA3060 V1
Post-AMM risk monitoring methods
Pharmacovigilance- Adverse drug reaction monitoring

Author : Elisabeth POLARD

Publication date: June 10, 2016, Review date: May 27, 2020 | Lire en français

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4. Post-AMM risk monitoring methods

4.1 Spontaneous notification

Spontaneous reporting of adverse drug reactions is the cornerstone of any health alert system.

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4.1.1 Principle

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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