Signal Management in Pharmacovigilance: From Detection and Validation to Benefit-Risk Decisions and Regulatory Action - Softcover

Selim, Hafez

Softcover

ISBN 13: 9798182786652

Publisher: Selim Medical Press, 2026

Synopsis

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.

About this title

About the Author

Dr. Hafez Selim, MD, PhD, is a physician-scientist who works in drug safety and clinical development at a top-ten global pharmaceutical company, where his work covers benefit-risk assessment, signal detection and evaluation, and periodic safety reporting. He previously spent nearly a decade as Medical Advisor and Safety Physician in the spine division of a leading global medical device company. His regulatory experience spans the FDA, EMA, MHRA, and PMDA. He earned his MD from Ain Shams University, a PhD in Anatomy and Cell Biology from Temple University, and a Graduate Diploma in Applied Biostatistics from the University of Minnesota, and completed a postdoctoral fellowship at Harvard Medical School / Massachusetts General Hospital. He holds four patents in biomaterial technologies and has published 49 journal articles.

Edition details

• Publisher: Selim Medical Press
• Publication date: 2026
• Language: English
• ISBN 13: 9798182786652
• Binding: Paperback
• Number of pages: 488