ICSR Management

ICSR Management

Why Deduplication Matters in Literature Processing

This article explains why deduplication in literature processing matters, how duplicate records can arise, and its role in strengthening the overall literature screening workflow.

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ICSR Management

Pregnancy Registries in Pharmacovigilance: Importance, Purpose, and Monitoring

This article explains the purpose & key characteristics of pregnancy registries, their role in long-term safety monitoring & evaluating potential safety signals.

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ICSR Management

Action Taken and Outcome: Explained

This comprehensive blog will guide you through the fundamentals of “action taken” in case files and its impact on patient outcomes, highlighting their interrelation.

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ICSR Management

Case Classification vs Report Type in Pharmacovigilance: Key Differences Explained

This article explains their key differences, practical applications, and how using both correctly improves case triage, regulatory reporting, and overall drug safety operations.

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ICSR Management

Managing Pregnancy Reports in Pharmacovigilance: A Practical Guide

This practical guide explains how to track, assess, and process pregnancy reports, determine which cases qualify as ICSRs, reporting in E2B(R3),

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ICSR Management

SAR vs SAE in Pharmacovigilance: Definitions, Differences, & Key Concepts

This article explains the definitions, highlights the critical differences between SAR and SAE, and explores the key concepts in pharmacovigilance.

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ICSR Management

Country Attribution in ICSRs: Rules, Challenges, & Best Practices

A quick guide to country attribution in ICSRs and their role in ensuring accurate, compliant safety reporting.

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ICSR Management

Causality Classification in Pharmacovigilance: Explained

A simplified guide to causality assessment in pharmacovigilance, covering WHO-UMC classifications and key criteria for evaluating adverse drug reactions.

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