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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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.
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Decoding Why Severe Isn’t Always Serious
This article demystifies the distinction between the two, the terms why severe isn’t always serious are often misunderstood—and mistakenly used interchangeably.
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Marketing Authorization Holder (MAH)
This comprehensive blog that guide o explore the critical role and responsibilities of Marketing Authorization Holder (MAH) in the pharmaceutical industry.
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Risk Register: An Overview
This blog covers the following topics: Overview Risk registers are a critical component of any business, helping to identify, assess, and reduce potential risks early on. Implementing a risk register is essential for integrating effective risk management into your processes, regardless of the activity or industry. Risk Registers There are various types of risk registers,…
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From Start to Finish: Data-Entry in Pharmacovigilance
In this comprehensive blog discussing data entry into databases, we will explore essential factors to consider and apply when dealing with Adverse Event coding. Check this out.
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Reports vs Reporters: Decoding Case Types
This blog covers: Introduction In this blog, we explore how report types can vary depending on the reporter, and conversely, how the reporter can often be inferred from the type of report submitted. While this isn’t a strict rule, it provides useful insights into how reports are typically classified and understood within case processing. Reports…
