Drug Safety Insights

Pharmacovigilance Blog

Expert insights, industry updates, and practical guides on drug safety monitoring and regulatory compliance.

205Articles
13Categories
10Topics
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Public Authorities and Safety

Understanding the Essence of 21 CFR Part 11

In this extensive blog post, we will explore into the nuances of 21 CFR Part 11, exploring its significance within the pharmaceutical domain and why compliance is essential.

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Public Authorities and Safety

ICH Members and Observers: An Overview

This article provides an overview of ICH Members and Observers, explains their roles and participation involved in global regulatory harmonisation.

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ICSR Management

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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Literature Screening

Designing Literature Search Strategy

Learn how to design a robust literature search strategy for pharmacovigilance and biomedical research. This guide explains how to define your research question.

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Drug safety and pharmacovigilance

What are IME listings?

This article provides an overview of Important Medical Event (IME) listings, their development, and their role in pharmacovigilance.

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Drug safety and pharmacovigilance

Compliance for Beginners: Pharmacovigilance

This article simplifies key compliance concepts, highlights practical do’s and don’ts, and provides essential insights to help case processors and newcomers.

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Drug safety and pharmacovigilance

Regulatory intelligence

In today’s rapidly evolving compliance landscape, Regulatory Intelligence has emerged as a strategic necessity rather than a back-office function.

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Public Authorities and Safety

National Pharmacovigilance Centres

This article outlines their purpose, necessity, & key responsibilities in ensuring the safety of medicinal products at National Pharmacovigilance Centres.

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Talk About Quality

A Good case report

High-quality case reports form the backbone of effective pharmacovigilance. This article explores what defines a good case report in pharmacovigilance.

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Exploring Adverse Events

Death vs Fatal vs Life-threatening

This article breaks down the terms such as death, fatal, and life-threatening are often used interchangeably—yet each carries a distinct regulatory meaning.

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ICSR Management

QPPV and LPPV Explained

This blog features: Introduction This blog provides a clear and concise overview of the Qualified Person for Pharmacovigilance…

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ICSR Management

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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MedDRA Series

MedDRA Codes: What Makes Them Unique

MedDRA codes explained in a simple and concise way—learn what they are, how they work, and why these unique 8-digit identifiers matter in pharmacovigilance.

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Exploring Adverse Events

Beyond ADRs: Reports Managed in PV

This blog covers the following: Introduction Pharmacovigilance involves much more than just managing adverse reactions or events with…

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ICSR Management

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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Exploring Adverse Events

Death: An Adverse Event

This blog features: Introduction This comprehensive article explores how to handle fatal cases, which are classified under the…

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ICSR Management

Risk Register: An Overview

This blog covers the following topics: Overview Risk registers are a critical component of any business, helping to…

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Drug safety and pharmacovigilance

📑 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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Our Services Explained

Product complaint management

This blog covers: Introduction In this article, we explore everything you need to know about product complaint management,…

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Techs & Tools

Evolution of pharmacovigilance database

From this pharmcovigilance blog, where we explore the fascinating evolution of pharmacovigilance databases. In this article, we delve into the origins of pharmacovigilance databases and trace their journey to their current state of utilization.

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Talk About Quality

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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Drug safety and pharmacovigilance

Causality: Known by Three Distinct Names

This blog covers: Introduction Causality is a well-known concept, and in pharmacovigilance, its assessment is fundamental—case processing simply…

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Who & When & How

A Guidance for Newcomers: Choosing Between Pharmacovigilance and Clinical Trials

In this all-encompassing career development blog, you will delve into the decision-making process of choosing between pharmacovigilance and clinical trials. Rather than hesitating and potentially making the wrong choice, it is essential to opt for the right one from the start. Let’s explore and make an informed decision together.

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Drug safety and pharmacovigilance

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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Our solutions

Is Our Approach to Training Truly Effective?

Welcome to our blog, where we provide comprehensive details and offer effective ideas to enhance your productivity. We understand that sometimes our usual approaches may not yield the desired results, so we encourage you to explore alternatives.

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ICSR Management

Fundamentals of ICSR in pharmacovigilance

This blog is to explain about the fundamentals of Individual Case Safety Reports (ICSRs) and present them in an easily understandable manner. In this article, we provide dedicated definitions of key ICSR terms, ensuring clarity and comprehension with references.

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Exploring Adverse Events

No Adverse Event: A Comprehensive Overview

This comprehensive blog provides an in-depth look at what no adverse event reports are, while also addressing the uncertainties and scenarios you may encounter when handling these reports.

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ICSR Management

Master Cases in ICSR Management

In this blog, we take a deep dive into ICSR management, focusing on an important aspect: managing duplicates. This time, we explore the process of selecting a master case for merging duplicate cases effectively.

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ICSR Management

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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Exploring Adverse Events

Misuse, Abuse & Addiction: An Adverse Event

In this comprehensive blog guide, we uncover the distinctions between misuse, abuse, and addiction as reported in pharmacovigilance, providing clear differentiations with relevant examples.

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MedDRA Series

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.

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ICSR Management

Mastering Duplicate Detection: Your Ultimate Guide

In this detailed blog, we delve into the detection of duplicates in pharmacovigilance case processing, incorporating statistical insights throughout our exploration. Join us on our journey as we share our findings and insights.

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ICSR Management

Pregnancy cases in PV: An overview

In this comprehensive blog, you will explore the various categories and scenarios involved in handling pregnancy cases within pharmacovigilance case processing. Let’s dive in!

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Our solutions

Common mistakes to avoid in Pharmacovigilance Coding

In this blog, where we shed light on the common mistakes often encountered by pharmacovigilance coders in their daily work. It’s easy to overlook the potential errors that can occur within our processes if we’re not aware of them. By identifying and addressing them, we aim to improve the overall accuracy and efficiency. Join us as we explore the world of pharmacovigilance.

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ICSR Management

Picking Receipt Dates For Various Scenarios

In this article, you’ll learn how to picking receipt dates during case processing in various scenarios—a commonly confusing aspect. We will explore the complexities involved and provide clarity on this often intricate topic.

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ICSR Management

E2B and E2B(R2) and E2B(R3): The Variations

Welcome to our informative blog. Here you can learn about the difference between E2b (R2) and E2b (R3), Building upon our previous discussion about E2B, we now delve deeper into the evolution of the E2B standard.

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Drug safety and pharmacovigilance

CAPA Cases in Pharmacovigilance: An Overview

In this detailed blog, we explore into CAPA cases, their workflow, and their significance within pharmacovigilance. Explore further to gain a deeper understanding of how to effectively manage CAPA within this context.

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ICSR Management

The Significance of Receipt Dates in Pharmacovigilance

In this blog, where you can learn the significance of receipt dates in ICSR (Individual Case Safety Report) case processing and their impact on submissions. Join us as we explore the context of case processing in related with receipt dates.

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MedDRA Series

MedDRA: Identifying the Closest LLTs

In this comprehensive blog, we delve into key tips for effectively performing MedDRA coding, addressing common sources of confusion. Here are a few valuable tips worth exploring.

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ICSR Management

Exploring the Origins: Sources of ICSR reports

In this article, we delve into the scope and purpose of ICSR reports, shedding light on the reporters involved and the sources they draw upon. If you’re interested in gaining a deeper understanding of pharmacovigilance, this article is sure to provide valuable insights.

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Drug safety and pharmacovigilance

❇ Thalidomide incident and pharmaceutical industry

Welcome to our comprehensive blog where we delve into the transformative impact of thalidomide and its lasting influence on the cost burden of drugs in our society today. Gain a deep understanding of how the incident reshaped the way we approach drug development, testing, and regulation.

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ICSR Management

Expedited Safety Reporting: Everything you need to know

In this blog, you will learn the term what is expedited reporting mean in the field of pharmacovigilance, including its standards and requirements. We delve into the time-frames associated with different types of reports, ensuring that you have a clear understanding of the urgency.

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Exploring Adverse Events

╰┈➤ Drug Interactions: An Adverse Event

In this comprehensive blog, we decode the conventions for assessing and coding drug interactions as adverse events in pharmacovigilance case processing. Click to learn more in detail.

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Techs & Tools

࿔ Digital vs Electronic Signatures: Differences

In this article, where we address the recent knowledge surrounding the concept of digital signatures and electronic signatures. If you, like many others, have also been under the impression that these terms are same, this blog is for you. We aim to provide you to understand their unique characteristics and applications. Let’s debunk the confusion and gain a clear understanding of digital signatures and electronic signatures together.

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Who & When & How

ℹ The Complete Guide to Understanding Pharmacovigilance

This overview provides a comprehensive introduction to pharmacovigilance, covering all the basics you need to know. It serves as a starting point for beginners, offering a glimpse into key concepts that can ignite further learning and understanding.

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Medical dictionaries
MedDRA Series

Overview: Various Types of Medical Coding Dictionaries Explored

This detailed blog offers insights into lesser-known alternatives to MedDRA, providing valuable information about alternative classifications endorsed by recognized authorities, which might not enjoy the same level of popularity as MedDRA but are nonetheless produced by reputable organizations.

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MedDRA Series

MedDRA in Focus: A Comprehensive Overview

In this comprehensive blog, you’ll discover lesser-known facts about MedDRA that may increase your curiosity. Designed as a fact-checking resource, it’s tailored to engage curious individuals seeking deeper insights into MedDRA.

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Drug safety and pharmacovigilance

🖇️ Understanding Temporal Relationships in Pharmacovigilance

In this comprehensive blog post, we explore into the concept of temporal relationships within pharmacovigilance, particularly focusing on assessing causality. The discussion includes important insights and illustrative examples to enhance understanding.

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Who & When & How

CAPA: Corrective Actions and Preventive Actions

In this extensive blog, we explore into the nuances of managing CAPA within organizations, shedding light on various situations that warrant its implementation. Additionally, we explore the necessity of CAPA in the context of inspections. Click to delve deeper into these topics.

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Our solutions

🔙 Mastering Backlog Management: Key Steps to Success

In this comprehensive blog, we dive into the intricacies of conducting backlog management within your organization, offering a simplified, step-by-step process for implementation. Click to delve deeper and gain valuable insights into optimizing your backlog management practices. #Blog/Excerpt

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Drug safety and pharmacovigilance

Risk Management in Pharmacovigilance (RMP)

This blog refers to the importance of risk management in pharmacovigilance and explore its definitions and significance. We highlight how a robust risk management plan plays a vital role in ensuring the safety and effectiveness of pharmaceutical products.

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ICSR Management

Causality Assessment in PV: Understanding the process

In this our informative blog, where we dive deep into the world of causality assessment in pharmacovigilance. you will understand the importance of understanding the definitions and stages that follow in this process, and that’s exactly what we aim to provide. Rather than relying on a rigid set of rules, we draw upon our extensive experience in the field to shed light on the steps involved.

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Who & When & How

Understanding a Complete PV System

This blog refers to the essential standards that encompass a comprehensive pharmacovigilance system within a company. Understanding the capabilities and components that are crucial in to it. In this insightful piece, we explore the key aspects that should be featured in such a system.

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Exploring Adverse Events

Overdose and Under-dose: Adverse Event Analysis

In this comprehensive blog, we provide a detailed overview of special adverse events such as overdose and underdose, focusing on their coding procedures and significance within the realm of pharmacovigilance.

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Drug safety and pharmacovigilance

Special Scenarios in Pharmacovigilance

In this comprehensive blog, we delve into reported special scenarios within the realm of pharmacovigilance. Our exploration encompasses detailed definitions of each scenario and outlines typical situations associated with them.

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Public Authorities and Safety

IDMP Standardization in PV: Why Are They Essential?

In this extensive blog, you will gain insights into the concept of IDMP standardization. While you might be familiar with the term, its significance might not be fully apparent until you explore its importance in detail here.

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Public Authorities and Safety

Understanding ICH Guidelines: An Overview

In this in-depth article, we’ll explore various nuances surrounding the International Conference of Harmonisation (ICH) organization, including its facts and guidelines. Let’s delve into the details.

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Techs & Tools

Pharmacovigilance Database: Lists & Features Explored

In this dedicated blog, we explore the crucial role of databases in the field of pharmacovigilance. We provide an overview of various databases that are integral to this field, highlighting their features and urls. While we acknowledge that there are numerous databases available, we share our knowledge of some important ones to enhance your understanding.

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Who & When & How

How pharmacovigilance industry reacted to COVID-19?

Welcome to our comprehensive blog report that delves into the transformative effects of the COVID-19 pandemic on the pharmacovigilance industry. In this article, we provide an in-depth analysis of how the field of pharmacovigilance has evolved in response to the global health crisis.

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Public Authorities and Safety

Role of WHO in Pharmacovigilance

In this blog you will know the details of the World Health Organization’s (WHO) role in pharmacovigilance. If you’re interested in understanding the contributions and significance of the WHO in ensuring global drug safety, you’ve come to the right place.

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Our solutions

Analyzing Common Challenges: Pv Services vs Core Companies

This dedicated blog takes a time to sincerely find out the major problem between pharmaceutical companies and pharmacovigilance services. So it aims to just demonstrate the problems that are, Join us on this journey as we seek to find effective solutions.

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ICSR Management

Significance & Criteria for Valid ICSR

In this dedicated Pharmacovigilance blog, where we shine a spotlight on the importance of valid Individual Case Safety Reports (ICSRs). Within the ICSR category, we will delve into the significance and explore the essential criteria that define a valid ICSR.

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ICSR Management

Coding of Adverse Events and Drugs: A quick-view

In this blog, where we explain the steps involve in the process of coding drugs and adverse events into the pharmacovigilance database. This critical step requires careful attention to important aspects to ensure accuracy and effectiveness. Join us as we delve into the world of coding drugs and adverse events.

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ICSR Management

Narratives in ICSR – A Deep Dive

In this comprehensive and expansive blog post, we will delve into the significance of narrative and its integral components within the context of ICSR (Incident, Safety, and Crisis Reporting).

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ICSR Management

A Newcomer’s Guide to ICSR Case Processing Workflow

This is a very late blog in this particular category, where we dive into the step-by-step process of ICSR (Individual Case Safety Report) case processing. Whether you are new to the field or seeking a refresher, this blog is designed to provide you with a comprehensive understanding of the process.

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Talk About Quality

Quality Upgrade: Simple Hacks for Seamless Case Processing

Welcome to our ICSR hacking blog focused on quality. In this article, we explore simple and easy daily routine of methods to enhance the quality of case processing. Rather than relying on discussing and gossiping, we draw from real-world experiences to provide you with logical insights and actionable tips. #Blog/Excerpt

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Drug safety and pharmacovigilance

Understanding Day-Zero(0) in Pharmacovigilance

In this comprehensive blog, you’ll uncover key information about what “Day Zero” signifies in the context of case processing and the broader field of pharmacovigilance. Additionally, you’ll gain insights into calculating the day of submissions.

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Who & When & How

Understanding Root Cause Analysis

This is a serious of blog explaining the associated processes, From this you will gain a knowledge on handling Root Cause Analysis in general way and explaining of implementing in your workplace.

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Exploring Adverse Events

Examining LOE cases in Pharmacovigilance

In this comprehensive article, we delve into the specifics of “LOE” (Lack of Efficacy) within the context of adverse events. We explore distinct scenarios to differentiate between what constitutes LOE and what does not.

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MedDRA Series

Structure of the MedDRA Hierarchy

This blog provides a comprehensive explanation of the hierarchical structure in MedDRA, complete with clear and concise definitions. It also includes a diagrammatic representation of the hierarchy to facilitate your better understanding of the system.

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Drug safety and pharmacovigilance

The Importance of Reporting Adverse Event(s)

In this comprehensive blog, we delve into why reporting adverse events is crucial for public safety and discuss the concerning issue of the rapid and widespread lack of adverse event reports.

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ICSR Management

Decoding Medical Review in Pharmacovigilance

Discover the role of the medical review in pharmacovigilance, including its responsibilities and eligibility criteria. Click to delve deeper into this insightful exploration. Read more here.

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Public Authorities and Safety

Contribution of CIOMS in Pharmacovigilance: An overview

In this comprehensive blog, we will delve into the fundamentals and history of CIOMS, the Council for International Organizations of Medical Sciences. While many of us are aware that CIOMS is a non-profit organization, its significance goes beyond that.

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ICSR Management

10 best practice to follow in case-intake process

In this blog, we delve into the world of pharmacovigilance and explore the essential considerations for effective case intake. We provide you with exceptional ideas and valuable insights on how to navigate this crucial stage of intake of cases in the pharmacovigilance process.

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Techs & Tools

Key FOSS Tools: Enhancing Business Efficiency

This blog aims to explore essential tools that can significantly enhance your business operations, leading to excellent profits, all while bypassing the need for costly proprietary software. We will delve into alternative solutions that provide exceptional performance without burdening your budget.

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Drug safety and pharmacovigilance

Pharmacovigilance – The Basics

In this comprehensive blog, where we provide a comprehensive overview of pharmacovigilance. Whether you’re new to the field or seeking a refresher, our blog is here to guide you through the basics of pharmacovigilance.

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Techs & Tools

Save Business Expenses: 6 Free Tools for Email Collection

In this article, I briefly provide an overview of the resources I use to collect emails for my business development with no costs. Although it is time-consuming process and may not suitable for everyone, I still share my experience for those starting a business on a limited budget might helpful.

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Drug safety and pharmacovigilance

Understanding Action Items in pharmacovigilance

From this insightful blog, where you can learn all about action items and provide guidance on how to handle them promptly in various circumstances. By the end of this blog, you’ll have the knowledge to confidently address action items and drive progress.

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ICSR Management

Causality Assessment in PV: The Criteria and Category

Welcome to our blog, where we demystify the concept of causality assessment in the pharmacovigilance process. We understand that grasping the criteria and categories of causality assessment can sometimes be challenging. That’s why we’re here to simplify it for you, presenting the information in an easy-to-understand manner.

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ICSR Management

Crafting a Well-Structured ICSR Narrative

Within this extensive pharmacovigilance blog, specifically focusing on Individual Case Safety Reports (ICSRs), we meticulously construct a model narrative, line by line, outlining the essential information to be incorporated. By engaging with this content, you’ll acquire valuable insights into narrative writing within the context of ICSR reporting.

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Exploring Adverse Events

Counterfeit Drugs: An Adverse Event

In this comprehensive article, we delve into the world of counterfeit medicines. We explore what they are, how they are classified as adverse events, and the considerations involved.

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Drug safety and pharmacovigilance

Understanding Civil Money Penalties

In this pharmacovigilance blog, we will delve into the details of civil penalties, addressing any uncertainties regarding the amount of penalties for late submissions or the provision of misleading data. Take a moment to read and gain clarity through this blog. Happy reading!

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Drug safety and pharmacovigilance

Validating Incident Country: Key in Case Processing

Welcome to our informative pharmacovigilance blog, where we explore the significance of the country of incidence in ICSR (Individual Case Safety Report) case processing and its potential impact on the outcome of the case. Join in our journey through the world of pharmacovigilance.

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MedDRA Series

The Vision and Mission of MedDRA

In this insightful blog post, you will delve deep into the intricate layers of MedDRA’s vision and mission, exploring its evolution over time, and its ambitious overarching goals. Ultimately ensuring public safety and enhancing the quality of healthcare services.

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Featured image for the blog explaining about Adverse Event Reporting System
Public Authorities and Safety

Adverse Event Reporting System (AERS) – An overview

Welcome to this insightful blog, where we delve into the purpose and benefits of AERS (Adverse Event Reporting System) and explore how it aids regulatory bodies in effectively addressing the potential harmful effects of drugs on the general population. Join us as we uncover the significance of AERS in ensuring drug safety and public health.

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Talk About Quality

Achieving Quality output: The Best Practices

In this informative pharmacovigilance blog, where we provide you with a wealth of knowledge on conducting quality checks in Individual Case Safety Report (ICSR) cases. Discover in-depth information, insights and responsibilities about the guidelines associated with performing these checks.

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Featured display for the blog where we explain about the various regulatory timelines for report submission
Public Authorities and Safety

The Clock is Ticking: Significance of Regulatory Timelines

From this blog, where you systematically explore regulatory timelines based on case criteria determined by authorities. If you’re looking to navigate the complexities of regulatory timelines, you’ve come to the right place.

Bala
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Featured image for the blog which explains about the role of Drug Regulatory Bodies in favour of public health
Public Authorities and Safety

Role of Drug Regulatory Bodies: Guardians of Public Health

In this comprehensive blog, where we delve into the world of regulatory authorities and their dedicated roles. If you’ve ever wondered about the crucial functions performed by regulatory bodies, you’ve come to the right place.

Bala
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Featured image to display on the blog which explains about the importance of triage in pharmacovigilance
Drug safety and pharmacovigilance

The Essential Role of Triage in Pharmacovigilance

Welcome to the next instalment of our blog series on case triage in pharmacovigilance, where we explore why triage is a crucial part of case processing. In this blog, we will provide you with a comprehensive understanding through the lens of triage.

Bala
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We are Drugvigil (pharmacovigilance service provider) headquartered in India. We also do our limited operations at Tbilisi, Georgia. We help pharmaceutical companies and healthcare professionals improve the safety of their products.

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