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Fundamentals of Pharmacovigilance

Mr. Abhay Joshi, Dr. Vikas Rajurkar, Ms. Manasi Mistry, Mr. Sandesh Dahiwal, Ms. Varsha Patwekar (Lad)
4.9/5 (12289 ratings)
Description:Fundamentals of Pharmacovigilance: Principles, Practice and Case Management is a comprehensive and practice-oriented guide designed for students, healthcare professionals, and beginners entering the field of drug safety. The book offers a clear and structured journey through the core concepts of pharmacovigilance, beginning with the foundational principles that define the science and its role in safeguarding public health. It then moves into the practical aspects of case processing and management, exploring event seriousness, causality assessment, labeling concepts, and the nuances of dechallenge–rechallenge. Readers are introduced to essential regulatory constructs such as Individual Case Safety Reports (ICSRs), SUSARs, and special-situation scenarios commonly encountered in industry practice. The book also explains global regulatory authorities, submission timelines, and the use of standardized medical terminologies, including MedDRA and WHO-Drug Dictionary, ensuring readers understand how consistent coding drives high-quality safety data. With its blend of theory, real-world relevance, and systematic chapter organization, this book serves as a valuable resource for learning, training, and applying pharmacovigilance principles in professional settings.We have made it easy for you to find a PDF Ebooks without any digging. And by having access to our ebooks online or by storing it on your computer, you have convenient answers with Fundamentals of Pharmacovigilance. To get started finding Fundamentals of Pharmacovigilance, you are right to find our website which has a comprehensive collection of manuals listed.
Our library is the biggest of these that have literally hundreds of thousands of different products represented.
Pages
145
Format
PDF, EPUB & Kindle Edition
Publisher
Shashwat Publication
Release
2025
ISBN
xmlKAAAAMAAJ
Description: Fundamentals of Pharmacovigilance: Principles, Practice and Case Management is a comprehensive and practice-oriented guide designed for students, healthcare professionals, and beginners entering the field of drug safety. The book offers a clear and structured journey through the core concepts of pharmacovigilance, beginning with the foundational principles that define the science and its role in safeguarding public health. It then moves into the practical aspects of case processing and management, exploring event seriousness, causality assessment, labeling concepts, and the nuances of dechallenge–rechallenge. Readers are introduced to essential regulatory constructs such as Individual Case Safety Reports (ICSRs), SUSARs, and special-situation scenarios commonly encountered in industry practice. The book also explains global regulatory authorities, submission timelines, and the use of standardized medical terminologies, including MedDRA and WHO-Drug Dictionary, ensuring readers understand how consistent coding drives high-quality safety data. With its blend of theory, real-world relevance, and systematic chapter organization, this book serves as a valuable resource for learning, training, and applying pharmacovigilance principles in professional settings.We have made it easy for you to find a PDF Ebooks without any digging. And by having access to our ebooks online or by storing it on your computer, you have convenient answers with Fundamentals of Pharmacovigilance. To get started finding Fundamentals of Pharmacovigilance, you are right to find our website which has a comprehensive collection of manuals listed.
Our library is the biggest of these that have literally hundreds of thousands of different products represented.
Pages
145
Format
PDF, EPUB & Kindle Edition
Publisher
Shashwat Publication
Release
2025
ISBN
xmlKAAAAMAAJ
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