Pharmacovigilance: A Practical Approach, 2nd Edition (Original PDF from Publisher)
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Ensure patient safety and regulatory compliance with Pharmacovigilance: A Practical Approach, 2nd Edition—a must-have guide for pharmacovigilance professionals, regulatory officers, and clinical researchers. This fully updated 2025 edition, published by Elsevier, provides hands-on strategies and real-world applications for monitoring, assessing, and minimizing adverse drug reactions (ADRs). With its clear structure and practical focus, it’s the ideal resource for both seasoned professionals and those entering the field of drug safety.
Description
Pharmacovigilance: A Practical Approach, 2nd Edition offers a comprehensive and accessible framework for implementing effective pharmacovigilance systems. With increasing regulatory demands and public expectations for drug safety, this book addresses the urgent need for professionals who can manage benefit-risk evaluations, signal detection, and post-marketing surveillance with precision and accountability.
This book is tailored for pharmacovigilance officers, clinical research associates, regulatory affairs specialists, pharmacists, and healthcare professionals engaged in drug safety and lifecycle management. It is also a valuable academic resource for students of pharmaceutical sciences and regulatory studies.
Key Features and Highlights
- In-depth coverage of global pharmacovigilance regulations and frameworks (FDA, EMA, WHO)
- Step-by-step guidance on case processing, signal management, and safety reporting
- Practical tools and checklists for risk minimization strategies and compliance audits
- Real-world examples from industry case studies and regulatory inspections
- Updated insights on digital health technologies, AI in signal detection, and REMS
- Includes core chapters on adverse event reporting, benefit-risk assessment, and PV systems implementation
Topics Covered
This edition includes core chapters on:
- Adverse drug reaction (ADR) identification and classification
- Pharmacovigilance system setup and management
- Signal detection methodologies and tools
- Global pharmacovigilance legislation and compliance
- Risk communication and stakeholder engagement
- Challenges in biologics and vaccine safety
- Role of pharmacovigilance in clinical trials and post-marketing surveillance
About the Author
The author is an internationally recognized expert in pharmacovigilance and regulatory affairs, with decades of industry and academic experience. Their contributions span global drug safety strategies, educational program development, and consultation with health authorities and pharmaceutical firms.
Format and Technical Specifications
- Format: Original PDF (from publisher)
- Edition: 2nd Edition (2025)
- Publisher: Elsevier
- Language: English
- File Size: Approximately 15–30 MB
- Device Compatibility: Compatible with all PDF-supported devices including PC, Mac, iPad, Android tablets, and eReaders that support PDF (e.g., Kindle, Kobo with PDF support)
Frequently Asked Questions
Q1: Does this edition cover the latest ICH E2E and EU GVP Module updates?
Yes, the 2nd edition integrates the latest ICH and Good Pharmacovigilance Practices (GVP) guidelines, ensuring regulatory alignment and practical implementation advice.
Q2: Is this PDF version fully searchable and printable?
Yes, the official PDF version from the publisher is fully searchable, printable, and includes all visual aids and references from the print edition.
Additional information
| Publisher |
Elsevier |
|---|---|
| Published Year |
2025 |
| Language |
English |
| ISBN |
978-0443118814 |
| File Size |
54.3 MB |
| Edition |
2 |
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