Category: ICSR Management
Greetings and welcome to our ICSR community! Here, we share valuable insights on the nuances of ICSR case processing, no matter how small, to help you process cases effectively. We believe in sharing knowledge and information that we have to help our community grow.
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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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QPPV and LPPV Explained
This blog features: Introduction This blog provides a clear and concise overview of the Qualified Person for Pharmacovigilance (QPPV) — what the role entails, its key responsibilities, and the scope of its authority. It also highlights the distinctions between QPPV and LPPV (Local Person for Pharmacovigilance), offering essential insights into how these roles function within…
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Becoming a Trusted Pharmacovigilance Partner
Setting up a PV service business is a complex. This article explores what it truly takes to become a reliable and effective pharmacovigilance service provider.
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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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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.
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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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Condition aggravated: A scenario
Understanding how to handle condition aggravated as reported as an adverse event is a common challenge in pharmacovigilance case processing. Let’s dive in.
