Signal Management in Pharmacovigilance : From Detection and Validation to Benefit-Risk Decisions and Regulatory Action
Language: English
Published by Selim Medical Press, 2026
- Softcover
- New
Seller: AHA-BUCH GmbH, Einbeck, GermanyAHA-BUCH GmbH
AbeBooks seller since August 14, 2006
Condition: New
£ 76.63
Quantity: 2 available
Add to basketItem description from seller
nach der Bestellung gedruckt Neuware - Printed after ordering - A practical, end-to-end guide to pharmacovigilance signal management - from the first disproportionality statistic to the final regulatory decision.Every marketed medicine generates a steady stream of safety data. The hard part is not collecting it but deciding, consistently and defensibly, which patterns are real, which matter, and what to do about them. This book follows the full signal management lifecycle as it is practised in industry and regulatory agencies today: detection, validation, prioritization, assessment, benefit-risk integration, decision-making, and regulatory action.Written by a physician-scientist with experience across drug safety, clinical development, and medical devices, the book is built for the people who do this work - safety physicians, signal management scientists, pharmacovigilance and regulatory professionals, and those training to join them.Inside you will find: - 28 chapters in six parts, covering data sources, quantitative and qualitative detection, validation, prioritization, causality, benefit-risk, governance, and communication- Ten longitudinal case studies with fixed data dossiers that recur across chapters, so you can follow a signal from first report to final action- 40 figures and more than 120 worked exhibits and tables- 'The Bottom Line' at the end of every chapter - a plain-English, actionable take-home- 140 knowledge-check questions with a full answer guide- A 21-item practical toolkit and a free companion web tool for disproportionality, observed-to-expected, time-to-onset, validation, prioritization, and causality analysesCurrent to 2026 regulatory developments, including ICH E2D(R1), recent EU pharmacovigilance legislative changes, and FDA's transition from FAERS to AEMS, this is both a desk reference and a training text for anyone responsible for turning safety data into sound decisions. …
Seller Inventory # 9798182786652
- Title
- Signal Management in Pharmacovigilance : From Detection and Validation to Benefit-Risk Decisions and Regulatory Action
- Author
- Hafez Selim
- Publisher
- Selim Medical Press
- Publication year
- 2026
- Condition
- Neu
- Binding
- Taschenbuch
- Language
- English
- ISBN 13
- 9798182786652
- Item weight
- 1,216 grams
- Dimensions
- 280x216x26 mm
A practical, end-to-end guide to pharmacovigilance signal management - from the first disproportionality statistic to the final regulatory decision.
Every marketed medicine generates a steady stream of safety data. The hard part is not collecting it but deciding, consistently and defensibly, which patterns are real, which matter, and what to do about them. This book follows the full signal management lifecycle as it is practised in industry and regulatory agencies today: detection, validation, prioritization, assessment, benefit-risk integration, decision-making, and regulatory action.
Written by a physician-scientist with experience across drug safety, clinical development, and medical devices, the book is built for the people who do this work - safety physicians, signal management scientists, pharmacovigilance and regulatory professionals, and those training to join them.
Inside you will find:
- 28 chapters in six parts, covering data sources, quantitative and qualitative detection, validation, prioritization, causality, benefit-risk, governance, and communication
- Ten longitudinal case studies with fixed data dossiers that recur across chapters, so you can follow a signal from first report to final action
- 40 figures and more than 120 worked exhibits and tables
- "The Bottom Line" at the end of every chapter - a plain-English, actionable take-home
- 140 knowledge-check questions with a full answer guide
- A 21-item practical toolkit and a free companion web tool for disproportionality, observed-to-expected, time-to-onset, validation, prioritization, and causality analyses
Current to 2026 regulatory developments, including ICH E2D(R1), recent EU pharmacovigilance legislative changes, and FDA's transition from FAERS to AEMS, this is both a desk reference and a training text for anyone responsible for turning safety data into sound decisions.
"Synopsis" may belong to another edition of this title.
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"About the title" may belong to another edition of this title.
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