Selim hafez (46 risultati)

PAP. Condizione: New. New Book. Shipped from UK. Established seller since 2000.

PAP. Condizione: New. New Book. Shipped from UK. Established seller since 2000.

Condizione: New.

PAP. Condizione: New. New Book. Shipped from UK. Established seller since 2000.

PAP. Condizione: New. New Book. Shipped from UK. Established seller since 2000.

PAP. Condizione: New. New Book. Shipped from UK. Established seller since 2000.

PAP. Condizione: New. New Book. Shipped from UK. Established seller since 2000.

PAP. Condizione: New. New Book. Shipped from UK. Established seller since 2000.

PAP. Condizione: New. New Book. Shipped from UK. Established seller since 2000.

PAP. Condizione: New. New Book. Shipped from UK. Established seller since 2000.

PAP. Condizione: New. New Book. Shipped from UK. Established seller since 2000.

Taschenbuch. Condizione: Neu. Neuware - Safety is never one person's job.A medical device is designed by engineers, cleared by regulators, chosen by physicians, and used - minute by minute - by nurses. Each holds a piece of its safety that no one else can hold for them. Yet almost every book on the subject speaks to only one of these readers. The Long Life of a Safe Device is written for all of them at once.This is a practical, plain-spoken guide to keeping medical devices - and the patients who depend on them - safe across a device's entire lifecycle, from the first design decision to final disposal. It turns the core disciplines of device safety into a single, readable narrative, and wherever a point lands differently for a nurse, a physician, or an engineer, a short labeled aside says so.>What a medical device is, how it's classified, and the global regulatory landscape (FDA, EU MDR/IVDR, and beyond)Risk management the way ISO 14971 intends it - from hazard identification and estimation to risk controls and residual riskSafety built in during development: quality systems (ISO 13485), biocompatibility (ISO 10993), materials of animal origin, and clinical evaluationSafety defended in the market: maintenance, user training, vigilance and incident response, causality assessment, post-market surveillance, PMCF, and PSURs>Who it's for: Nurses and clinicians at the point of care. Physicians selecting and overseeing devices. Design, quality, and regulatory engineers who build the evidence. Safety and pharmacovigilance professionals who monitor devices in use. Students and newcomers who want the whole picture in one place.Clear enough to read cover to cover and organized to return to as a reference, The Long Life of a Safe Device gives every member of the team not only their own responsibility - but the visibility to trust their colleagues are holding theirs.Written by Hafez Selim, MD, PhD, a physician and scientist with deep experience in medical device and drug safety across the product lifecycle, from premarket development through post-market surveillance.…

Condizione: New.

PAP. Condizione: New. New Book. Shipped from UK. Established seller since 2000.

PAP. Condizione: New. New Book. Shipped from UK. Established seller since 2000.

Condizione: New.

PAP. Condizione: New. New Book. Shipped from UK. Established seller since 2000.

PAP. Condizione: New. New Book. Shipped from UK. Established seller since 2000.

PAP. Condizione: New. New Book. Shipped from UK. Established seller since 2000.

PAP. Condizione: New. New Book. Shipped from UK. Established seller since 2000.

Taschenbuch. Condizione: Neu. Neuware.

Taschenbuch. Condizione: Neu. Neuware - The first book on signal management written for medical devices.Device companies receive complaints, code them, decide what is reportable, and file on time. What most of them lack is an owner for the question that connects all of that work: what does this pattern mean, and what must change because of it Pharmacovigilance answered that question years ago with a named discipline. Device regulation never did. EU MDR Article 88 asks for trend reports, ISO 14971 asks for post-production information to flow into the risk file, and ISO 13485 asks for complaints to be investigated, but none of them tells a vigilance specialist how to recognize that three fractures at a new location matter more than ninety cosmetic complaints, or how to defend a decision not to act when an auditor reads the record two years later.This book fills that gap. In 28 chapters it follows a signal from the first complaint to the closed record: detection across complaints, returned devices, registries, clinical follow-up and device telemetry; control charts, CUSUM and Article 88 thresholds; disproportionality and registry outlier methods; time-to-failure and survival analysis; validation, prioritization and the written assessment question; case series and returned-device investigation; root cause across design, manufacturing, use and patient; integrated assessment and causality; the ISO 14971 risk file update; the action ladder from monitoring to field safety corrective action; benefit-risk; field safety notices; review boards, documentation, audits and metrics; and the place of AI and real-world data.Eight fictional devices carry the argument with fixed numbers that match across every chapter: a hip implant, an antibiotic-loaded bone void filler, an insulin pump, an infusion pump, a defibrillator lead, an AI triage tool, a surgical stapler and a central venous catheter. Every chapter ends with a one-page Bottom Line, five knowledge-check questions and an applied exercise, with full answers. A companion website provides 24 editable toolkit files, six calculators and an interactive Case Lab that runs all eight cases through the ten-step process.Written for manufacturer vigilance and post-market surveillance specialists, complaint-handling leads, safety physicians, risk management engineers, quality and CAPA owners, and regulatory affairs professionals. Companion to Signal Management in Pharmacovigilance by the same author.…

Taschenbuch. Condizione: Neu. Neuware - Applied Drug Safety and Adverse Drug Reactions: A Comprehensive ReferenceBy Hafez Selim, MD, PhD Foreword by Tim Sullivan, MDThe definitive reference for identifying, assessing, and managing adverse drug reactions - written by a practicing safety physician with 15+ years of global pharmacovigilance experience.Every medication carries the potential for harm. The challenge is not knowing that adverse drug reactions exist - it is recognizing them in real time, in real patients, amid competing diagnoses and incomplete information. This book gives you the framework to do exactly that.Applied Drug Safety and Adverse Drug Reactions is a comprehensive, organ-system-based reference covering the full spectrum of drug-induced injuries across 17 chapters. Each chapter follows a consistent clinical framework: mechanisms of injury, time-to-onset and risk window tables, differential diagnosis, causality assessment (Naranjo, WHO-UMC, RUCAM), clinical management, take-home messages, and peer-reviewed references.What makes this book different: Most pharmacology texts list adverse reactions. This book teaches you how to think about them. It emphasizes temporal patterns, dechallenge and rechallenge logic, and the structured reasoning that separates competent drug safety practice from guesswork.Chapters cover: Anaphylaxis, DILI, AKI, Blood Disorders, SJS/TEN and Skin Reactions, Drug-Induced Psychosis, Cardiac Disorders (QT Prolongation, Cardiomyopathy, Ischemia), Pulmonary Toxicity, Neurological Disorders, GI Reactions, Blood Pressure, Glucose Disturbances, Muscle Injury, Chemotherapy ADRs, Drug-Drug Interactions, ADR Reporting, and Risk Management. The Appendix provides detailed scoring guides for all three major causality assessment tools.Who this book is for: Safety physicians, pharmacovigilance scientists, pharmacists, clinical researchers, medical affairs professionals, regulatory professionals, and students building drug safety expertise.Online Learning Companion: Paired with the Applied Drug Safety Online Learning Platform at MedTech Talents Institute, featuring chapter quizzes, clinical simulations, and the Applied Drug Safety Diploma certification.…

PAP. Condizione: New. New Book. Shipped from UK. Established seller since 2000.

PAP. Condizione: New. New Book. Shipped from UK. Established seller since 2000.

PAP. Condizione: New. New Book. Shipped from UK. Established seller since 2000.

PAP. Condizione: New. New Book. Shipped from UK. Established seller since 2000.

Condizione: New. Print on Demand.

Condizione: New. Print on Demand.

Taschenbuch. Condizione: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering.