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Glossary

Signal

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Information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action 

Other glossary definitions

M

Medication error

Any unintentional error in the prescribing, dispensing, or administration of a medicinal product while under…

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R

Risk-benefit balance

An evaluation of the positive therapeutic effects of the medicinal product in relation to the…

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