Tag: Basics of pharmacovigilance
Within this tag, you will delve into comprehensive insights about pharmacovigilance. This tag proves captivating as it precisely outlines the nuances of pharmacovigilance for your understanding.
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📑 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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🆘 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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Product Quality Complaints: An Adverse Event
This blog covers: Product Quality Complaint (PQC) A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication alleging deficiencies related to a product’s identity, quality, durability, reliability, safety, effectiveness, or performance after its release and distribution in the market. This includes suspected medicine failures, damaged or missing products, incorrect strength or color,…
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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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Serious Adverse Events: Criteria and Guidelines
This blog explores how to effectively handle significant events, focusing on what qualifies as a “serious” event and the process of upgrading or downgrading events as they unfold. Understanding the severity of an event allows for a more adaptive and responsive approach to event management.
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🛕 SOC within MedDRA: Key Insights
This blog covers the following topics: Introduction As healthcare professionals, you’re likely familiar with MedDRA, or at least have heard of it. For pharmacovigilance professionals, We’ve covered MedDRA detailing in with a dedicated MedDRA series. In this post, we’re going to explore one of the key hierarchies within MedDRA: SOC (System Organ Class). Let’s dive…
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.•* MedDRA Coding: Core Principles Explained
n this MedDRA series article, we will explore additional tips to help enhance your case processing skills, particularly for those who may feel uncertain about MedDRA coding.
