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Research Article: A Risk-Based Approach for Safety Case Follow-up of Adverse Event Reports in Pharmacovigilance

Date Published: 2023-11-03

Introduction:
In the field of pharmacovigilance (PV), adverse event (AEs), or adverse drug reactions (ADRs) encompass any untoward medical occurrence in a patient or clinical investigation subject who has been administered a pharmaceutical product, even if it does not necessarily have a causal relationship with the treatment received [1]. An Individual Case Safety Report (ICSR) serves as the standardized format for submitting individual reports of AEs or ADRs associated with medicinal products that occur in a single patient at…

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