Hafez Selim
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 communicationTen longitudinal case studies with fixed data dossiers that recur across chapters, so you can follow a signal from first report to final action40 figures and more than 120 worked exhibits and tables'The Bottom Line' at the end of every chapter - a plain-English, actionable take-home140 knowledge-check questions with a full answer guideA 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.
