Category: Drug safety and pharmacovigilance
This category dedicated to the topics of drug safety and pharmacovigilance, with several subcategories available for exploration. Feel free to browse the various subcategories according to your interests.
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π Investigational Brochure (IB): An Overview
Welcome to our informative article, where we unravel the concept of the Investigational Brochure (IB). In this comprehensive piece, we aim to provide a clear understanding of what an IB is, its purpose, significance, and the important components it comprises.
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The Role of Pharmacovigilance in Clinical Trials
This blog features: Introduction This blog provides a clear understanding of why pharmacovigilance is a crucial aspect of clinical trials throughout the entire product life cycle. Although pharmacovigilance and clinical trials are distinct domains, both contribute significantly to ensuring drug safety. Pharmacovigilance plays a continuous role from development through post-marketing, safeguarding public health at every…
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π Spontaneous Reports: A Key Component of Pharmacovigilance
This blog includes: Introduction In the context of data collection, multiple report types contribute to the generation of safety reports. However, one source stands out for being less organized and accumulating large data, i.e, spontaneous reports. It significantly impacts the risk and benefit profile of drug safety. This section will explore this reporting system and…
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Quality Management System
In this blog, you will discover essential insights for enhancing your company’s quality, guided by the principles of GVP (Good Pharmacovigilance Practice). It contains a concise summary of critical information derived from GVP that is imperative for your knowledge.
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Causality: Known by Three Distinct Names
This blog covers: Introduction Causality is a well-known concept, and in pharmacovigilance, its assessment is fundamentalβcase processing simply cannot exist without it. However, within the pharmacovigilance domain, causality is often referred to using three distinct terms. If youβre experienced in the field, youβve likely come across them, but for beginners, these variations might be unfamiliar.…
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Unveiling Country Identifiers: Code Listing
This blog showcases a comprehensive list featuring alpha-2 and alpha-3 country codes, providing complete identification for each country. While it may seem somewhat distant within our niche, it remains relevant to the book-in process.
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π Decoding Personal Data in Pharmacovigilance Reporting
In this comprehensive blog, you’ll learn everything about handling personal data within pharmacovigilance reporting, along with crucial insights. Stay tuned for more updates!
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γ Solicited Reports vs Unsolicited Reports: Key Differences
This blog provides specific information on: Introduction In this write-up, you will have clarity from: Many people believe in a wrong way that solicited and unsolicited refer to the sources of reports, but that is not the case. Here, you will find detailed explanations to help you understand these concepts. Definitions Solicited Reports: These reports…
