Tag: All about ICSR processing
Within this tag, you will discover a complete repository of information pertaining to ICSR (Individual Case Safety Report) cases, presented systematically from top to bottom at each level.
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Pregnancy and Lactation: A Case Processing Perspective
This article explores the critical safety considerations surrounding pregnancy and lactation, highlights key distinctions in case assessment. Lets explore.
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Death vs Fatal vs Life-threatening
This article breaks down the terms such as death, fatal, and life-threatening are often used interchangeably—yet each carries a distinct regulatory meaning.
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Case Corrections in Pharmacovigilance
This blog explores what case corrections are, why they are necessary, and highlights common real-world examples every PV professional should know.
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Record Drug Indications in PV Cases Processing
Drug indications might seem like a simple detail, but in PV case processing they can quickly become tricky. Let’s discuss in deeper.
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Pregnancy reports: Paternal and Maternal
In this article, Pregnancy-related cases in pharmacovigilance present unique challenges, requiring careful assessment of both paternal and maternal exposures.
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Causality Assessment: Selection and Prioritize the Cases
This article explores how to effectively select and prioritize cases for causality assessment, with a special focus on serious and AEFI-related reports.
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Adverse Event Coding: Signs and Symptoms
This blog covers: Introduction Pharmacovigilance coding involves several complex and often confusing areas, including indications, adverse events, and current conditions. In this article, we will explore how signs, symptoms, and adverse events are identified, evaluated, and coded into a safety database, along with best practices for accurate and consistent reporting. Signs and symptoms: An overview…
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Warnings and Precautions: Key Insights from Safety Documents
This article explores how the Warnings and Precautions section of safety documents plays a critical role in this process. Let’s dive in and explore.
