Assessing Labelling, Listedness, Expectedness in Pharmacovigilance

Assessing Labelling, Listedness, Expectedness in Pharmacovigilance: Differences & Methodology used in assessment

Aggregate report writing, Individual Case Safety Reports, Pharmacovigilance, , ,

This concept involves determining whether any adverse drug reaction or adverse drug event is already known/already documented/already observed in subjects/patients who are under treatment with the investigational/marketed medicinal product. It determines the expeditious nature of an ICSR (Individual case safety report) by formulating the regulatory due timeline for submission to health authority (7/15 days). For…

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Causality Assessment in Pharmacovigilance

Causality Assessment in Pharmacovigilance: Concept & Methods

Aggregate report writing, Individual Case Safety Reports, Pharmacovigilance, , ,

Causality Assessment: Causality is an assessment procedure used for the determination of relationship between a drug treatment and the occurrence of an adverse drug event. When a causal relationship is identified, then adverse drug event (ADE) would be called as adverse drug reaction (ADR). The assessment of causality is a common procedure in pharmacovigilance, which…

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A signal of cardiac arrhythmias with the use of Ginkgo biloba L.

A new drug safety signal from UMC: Cardiac arrhythmia with the use of Ginkgo biloba L.

Drug Safety Signal, Global Safety Alerts, Individual Case Safety Reports, Medicinal Product Updates, Pharmacovigilance, WHO, , ,

WHO-Uppsala Monitoring Center (UMC) identified a new drug safety signal-“cardiac arrhythmias-Ginkgo biloba“ from the VigiBase, a global drug safety database maintained by UMC on behalf of WHO for international service and scientific research within the field of pharmacovigilance. In the month of July-2020, WHO-UMC has identified and released two new drug safety signals. Drug Safety…

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