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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Behind the Scenes of Drug Safety: Meet the Key Players
In This blog, You’ll discover: Introduction In any field of work, meaningful contributions are essential to achieving success—and pharmacovigilance is no exception. Contributors and collaborators play a crucial role in strengthening pharmacovigilance activities, ultimately helping to ensure public safety through the safe use of medicines. In this article, we’ll explore who these contributors are, what…
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Beyond ADRs: Reports Managed in PV
This blog covers the following: Introduction Pharmacovigilance involves much more than just managing adverse reactions or events with or without a causal relationship to a drug. Even among healthcare professionals, it’s common to refer to all safety-related reports simply as “adverse event reports.” However, pharmacovigilance encompasses a wider range of report types. In this article,…
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Pharmacists and Pharmacovigilance
This blog features: Introduction This article highlights the vital role of pharmacists in pharmacovigilance, emphasizing why they are often preferred over other healthcare professionals for key responsibilities in this field. It explores the unique qualifications and contributions that make pharmacists essential to the effective monitoring of drug safety. Through clear and focused points, this blog…
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Pharmacovigilance Regulatory Timelines: A Complete Guide
This blog covers: Introduction In today’s regulatory environment, every product must adhere to specific timelines to ensure safety, reliability, and public trust. In the field of drug safety, regulatory timelines play a critical role. They help ensure that safety data is reported and assessed promptly, minimizing risk to public health. Meeting these timelines is not…
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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,…
