{"product_id":"9798182786652","title":"Signal Management in Pharmacovigilance: From Detection and Validation to Benefit-Risk Decisions and Regulatory Action","description":"\u003cp\u003e\u003cstrong\u003eA practical, end-to-end guide to pharmacovigilance signal management - from the first disproportionality statistic to the final regulatory decision.\u003c\/strong\u003e\u003c\/p\u003e\u003cp\u003eEvery 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.\u003c\/p\u003e\u003cp\u003eWritten 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.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eInside you will find: \u003c\/strong\u003e\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e28 chapters in six parts, covering data sources, quantitative and qualitative detection, validation, prioritization, causality, benefit-risk, governance, and communication\u003c\/li\u003e\n\u003cli\u003eTen longitudinal case studies with fixed data dossiers that recur across chapters, so you can follow a signal from first report to final action\u003c\/li\u003e\n\u003cli\u003e40 figures and more than 120 worked exhibits and tables\u003c\/li\u003e\n\u003cli\u003e\"The Bottom Line\" at the end of every chapter - a plain-English, actionable take-home\u003c\/li\u003e\n\u003cli\u003e140 knowledge-check questions with a full answer guide\u003c\/li\u003e\n\u003cli\u003eA 21-item practical toolkit and a free companion web tool for disproportionality, observed-to-expected, time-to-onset, validation, prioritization, and causality analyses\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003eCurrent 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.\u003c\/p\u003e","brand":"Selim Medical Press","offers":[{"title":"Default Title","offer_id":48802195636465,"sku":"9798182786652","price":59.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0674\/5433\/7265\/files\/9798182786652_p0.jpg?v=1789931673","url":"https:\/\/shop.barnesandnoble.com\/products\/9798182786652","provider":"Barnes \u0026 Noble","version":"1.0","type":"link"}