Hafez Selim (32 results)

Condition: New.

Taschenbuch. Condition: 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.…

Condition: New.

Condition: New.

Taschenbuch. Condition: Neu. Neuware.

Taschenbuch. Condition: Neu. Neuware.

Taschenbuch. Condition: Neu. Neuware.

Taschenbuch. Condition: 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. Condition: Neu. Neuware - A medical device passes through many hands - designed by engineers, cleared by regulators, chosen by physicians, and used minute by minute by nurses - and its safety lives in the seams between those roles. Applied Medical Device Safety: A Comprehensive Guide is the rare book written for all of them at once, tracing a device's full life from design to disposal while teaching the working discipline that keeps patients safe at every stage.Part narrative and part training manual, the book builds from first principles: what a device is and how it is classified, the regulatory landscape it lives within, and the ISO 14971 risk-management process carried out end to end. From there it moves through the safety work of development - quality systems (ISO 13485), biocompatibility (ISO 10993), materials, and clinical evaluation - and into the market, where safety becomes a matter of maintenance, training, vigilance, and the structured investigations that follow an adverse event.At its operational heart is the Safety Specialist's Task Manual: step-by-step procedures for the tasks the role actually performs - writing and processing a case safety report, assessing causality, preparing aggregate reports and the PSUR, running a risk assessment, and constructing a defensible benefit-risk analysis - each with a working template, a fully solved example, and a self-check. Real device failures are then examined directly, and ready-to-adapt templates and interactive tools turn the methods into working aids.Whether you are a nurse or physician moving into device safety, an engineer who must defend a design in the regulatory file, or a professional who wants to become a medical device safety specialist, this is a single volume that explains the field and shows you how to do its work.…

Taschenbuch. Condition: Neu. Neuware - Which bone graft is best That is usually the wrong question.The more useful questions are: Which biological and mechanical properties does this specific defect require Does the proposed graft provide those properties How strong is the evidence-and what safety burden accompanies its use Safety and Effectiveness Profiles of Bone Grafts and Bone Graft Substitutes provides a practical, evidence-based framework for answering these questions. Written by physician-scientist and medical-device safety expert Dr. Hafez Selim, this comprehensive reference integrates bone biology, biomaterials science, clinical evidence, product safety, regulatory pathways, and real-world implementation.Inside, readers will find: - Detailed profiles of autografts, allografts, demineralized bone matrices, cellular bone matrices, xenografts, calcium-phosphate ceramics, cements, bioactive glass, synthetic composites, BMPs, PDGF products, P-15 peptides, marrow concentrates, and platelet-based therapies- Application-specific guidance for spine surgery, fractures, nonunion, segmental defects, foot and ankle procedures, dental and maxillofacial grafting, oncologic reconstruction, infection, and special populations- Structured methods for evaluating clinical effectiveness, adverse effects, donor-transmission risks, traceability, recalls, and post-market safety signals- Clear explanations of United States and European regulatory pathways-and why regulatory authorization should never be mistaken for clinical proof- Worked clinical vignettes, selection algorithms, evidence-appraisal checklists, comparison tables, a master material matrix, and a consolidated safety signal register- Practical guidance for patient optimization, shared decision-making, procurement, operating-room handling, documentation, outcome reporting, and institutional product review- An interactive companion tool that helps translate patient and defect characteristics into a required graft-property profileRather than treating every product within a material class as interchangeable, this book emphasizes exact formulation, processing, dose, carrier, indication, comparator, and clinical endpoint. It also identifies where evidence is strong, where extrapolation is inappropriate, and where uncertainty must be clearly communicated.With a foreword by Dr. Mohamed Attawia, this book is designed for orthopaedic, spine, foot-and-ankle, dental, and maxillofacial clinicians; trainees; biomaterials scientists; product-development engineers; medical safety and regulatory professionals; researchers; and hospital value-analysis teams.A rigorous and practical guide for anyone responsible for selecting, evaluating, developing, purchasing, monitoring, or regulating bone graft materials.Evidence reviewed through August 2, 2026.…

Taschenbuch. Condition: 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.…

Condition: New. Print on Demand.

Condition: New. Print on Demand.

Taschenbuch. Condition: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - Clear writing gets devices approved. Vague writing gets deficiency letters. Most regulatory submissions fail because of how the evidence is presented, not because the evidence is missing. Notified body reviewers flag unsupported claims, inconsistent terminology, hedged conclusions, and documents that do not trace back to one another. Write It Right is a practical field guide to fixing those problems before a reviewer finds them. Written by Dr. Hafez Selim, MD, PhD, a physician-scientist with more than two decades of experience in medical device safety, clinical evaluation, and regulatory affairs, this book focuses on the documents that matter most under the EU Medical Device Regulation (MDR 2017/745): technical documentation, clinical evaluation reports, risk management files, post-market surveillance reports, and responses to notified body questions. Inside you will learn how to:- Structure regulatory documents so reviewers can find and verify every claim- Replace vague, hedged language with precise, evidence-backed statements- Keep terminology, device descriptions, and claims consistent across the whole technical file- Write clinical evaluation and safety conclusions that stand up to scrutiny- Respond to deficiency questions clearly, completely, and on the first attempt Each chapter includes practice exercises, with a full answer key at the back of the book, so you can apply the principles right away rather than just read about them. Whether you are a regulatory affairs specialist, medical writer, clinical or quality professional, or an engineer who has been handed a technical file for the first time, Write It Right gives you the tools to produce documentation that is clear, defensible, and ready for review.…

Taschenbuch. Condition: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - A practical, evidence-based clinical guide to deciding when hyperbaric oxygen therapy belongs in diabetic foot ulcer care - and when it does not.Hyperbaric oxygen therapy (HBOT) remains one of the most debated adjuncts in advanced wound care. Positive trials and biological rationale coexist with negative modern studies, low-certainty recommendations, treatment burden, and uncommon but serious risks.For clinicians facing a nonhealing foot ulcer, the question is not whether HBOT always works or never works. It is whether this patient is likely to benefit after perfusion, infection control, debridement, offloading, metabolic management, and adequate standard care have been addressed.This clinician-focused guide will help readers:Understand why diabetic foot ulcers fail to heal and where wound hypoxia may contribute.Evaluate randomized trials, systematic reviews, guidelines, and conflicting clinical evidence.Distinguish systemic chamber-delivered HBOT from topical and normobaric oxygen therapies.Identify candidates using Wagner grade, perfusion, treatment response, contraindications, and ability to complete therapy.Plan treatment, measure response, and decide when HBOT should be continued or stopped.Recognize adverse effects, serious risks, and essential hyperbaric medicine safety systems.Practical resources include patient-selection and pretreatment safety criteria, the elements of informed consent, monitoring and adverse-event documentation standards, evidence tables, a patient handout, six teaching cases, and a one-page clinical decision algorithm.Written for wound-care physicians, podiatrists, hyperbaric clinicians, vascular specialists, nurses, researchers, and healthcare trainees, this evidence-based clinical guide connects diabetic wound healing, chronic wound management, and limb preservation with disciplined decision-making.HBOT helps some patients, cannot help most, burdens all, and harms a few. This book provides the framework needed to distinguish those groups - and to use HBOT responsibly without overselling its benefits or ignoring its limitations.…

Paperback. Condition: new. Paperback. 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. This item is printed on demand. Shipping may be from multiple locations in the US or from the UK, depending on stock availability.…

Condition: New. Print on Demand.

Taschenbuch. Condition: Neu. Write It Right | A Practical Guide to Medical Device Regulatory Writing | Hafez Selim | Taschenbuch | Englisch | 2026 | Dr. Hafez Selim MD, PhD | EAN 9798237404227 | Verantwortliche Person für die EU: Libri GmbH, Europaallee 1, 36244 Bad Hersfeld, gpsr[at]libri[dot]de | Anbieter: preigu Print on Demand.…

Taschenbuch. Condition: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - Every investigational drug in clinical development produces one document a year that asks a single question: given everything learned this year, is it still reasonable to expose people to this drug in trials That document is the Development Safety Update Report (DSUR), and the judgment it depends on is usually learned the slow way.Writing the DSUR is a practical, section-by-section manual for writing ICH E2F Development Safety Update Reports that regulators can trust. It goes beyond what the guideline requires to teach the judgment behind a strong report: deciding what the reporting period actually changed, reading imbalances in blinded data without unblinding, writing an overall safety assessment that interprets rather than repeats, keeping the summary of important risks honest from year to year, and running the process so the report lands inside the 60-day window.Inside you will find:Seventeen chapters in four parts: Foundations, the Data Layer, the Judgment Layer, and Craft and DeliverySection blueprints showing the logic, messaging and level of detail each DSUR section needs at each stage of developmentPractical guidance on reference safety information and expectedness, exposure estimates, and SAE listings and tabulationsRegional requirements and submission, quality control, inspection readiness and responding to regulator questionsA dedicated chapter for executive reviewers who sign off the reportFictional case files with an answer key, a section-level QC checklist, a timeline planner and RACI template, a glossary, and do's and don'ts at a glanceFree companion templates and a fully worked mock DSURWritten by Dr. Hafez Selim, MD, PhD, a physician-scientist with long experience in drug and medical device safety, for safety physicians, safety scientists, clinical development leads, medical writers and regulatory affairs professionals in pharma and biotech.…

Taschenbuch. Condition: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - Every periodic safety report ends with one sentence: the benefit-risk balance of the product remains favourable. This book is about how to earn it.Practical Benefit-Risk Assessment in Pharmacovigilance answers the question that guidance documents leave open: you have the efficacy and safety data, so how do you actually decide Across 33 chapters in seven parts, it follows the reasoning from a safety signal, through the structured qualitative frameworks, into quantitative analysis, and on to the regulatory documents where the conclusion has to be written down and defended.Part I sets out the concepts, evidence sources and uncertainty that underlie every assessment. Part II covers the frameworks regulators expect: the FDA Benefit-Risk Framework, the EMA effects table, PrOACT-URL and BRAT. Part III turns to quantitative methods - number needed to treat and number needed to harm, incremental net benefit, multi-criteria decision analysis with swing weighting, one-way and probabilistic sensitivity analysis, and Bayesian approaches. Part IV applies them across the product lifecycle, from first signal evaluation to periodic benefit-risk evaluation reports, risk management plans, development safety update reports and label changes. Later parts address special populations, communication, governance and the failure modes that recur in real assessments.One fictional medicine, Therapex, runs through the whole book. Every method is applied to the same dataset and the same clinical question, so the reader can see where two methods agree, where they diverge, and why. Each method chapter follows the same spine: the concept, the mathematics, a worked example, how to present the result, how to interpret it, its limitations, when to use it, and how to communicate it to a committee or a regulator.The book includes ten worked case studies, twenty-eight figures, four appendices of reference material and wording templates, and an interactive companion workbench that reproduces the calculators used in the text.It is grounded in CIOMS Working Group XII, ICH E2C(R2) and ICH E22, the FDA benefit-risk guidance, the EMA good pharmacovigilance practice modules, the IMI PROTECT roadmap and ISPOR good practices for quantitative benefit-risk assessment, and it is written by a physician-scientist whose career spans drug safety, clinical development and medical device regulation.Written for safety physicians, pharmacovigilance scientists, regulatory affairs and clinical development professionals, benefit-risk and epidemiology groups, and graduate students in pharmacoepidemiology and regulatory science.Foreword by Lisa Beth Ferstenberg, MD.…

Taschenbuch. Condition: Neu. 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.…

Taschenbuch. Condition: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - When Medicines Harm: Fifty-One Case Histories That Shaped PharmacovigilanceMost drug-safety rules were written after something went wrong. This book tells the story behind each one.In 1937 an untested solvent in a new antibiotic syrup killed more than 100 people, and the United States began requiring proof of safety before a drug could be sold. In the early 1960s a sedative sold as harmless caused a worldwide epidemic of birth defects, and modern drug regulation followed. In 2004 a blockbuster painkiller was withdrawn over heart risk, and US regulators gained new powers over marketed drugs. Nearly every requirement a drug-safety professional applies today goes back to a specific failure and a specific group of patients.When Medicines Harm collects 51 of those cases. They run from Elixir Sulfanilamide in 1937 to the end of the clozapine safety program in 2025, and include thalidomide, DES, fen-phen, Vioxx, TGN1412, contaminated heparin, Mediator, Pandemrix, nitrosamine impurities, the COVID-19 vaccines and the cough-syrup poisonings of the 2020s. Each chapter follows one case:Where it started: the clinical background and the first signal.Weighing the evidence: the explanations considered at the time and the evidence that finally settled the question.What followed: the regulatory response and what it changed.Built for teaching. Every chapter includes:Two decision points that stop the story at a real moment and ask what you would have done with only the evidence available then.Lessons for practice and discussion questions.Fully referenced sources, including later corrections where they exist.A scoring guide helps readers judge each decision. The epilogue draws out eight lessons that recur across the cases. The appendices summarize all 51 cases in one table, group them by how the harm was first detected, and define the key terms.Written for:Drug-safety physicians and pharmacovigilance scientistsRegulatory affairs professionalsTrainees and students in pharmacy, medicine and public healthAnyone who teaches drug safety through seminars, journal clubs or training programsAbout the author. Dr. Hafez Selim, MD, PhD, is a safety physician at a top-ten global pharmaceutical company. He previously spent nearly a decade in safety roles at a leading medical device company. His other books include Practical Benefit-Risk Assessment in Pharmacovigilance.…

Paperback. Condition: new. Paperback. 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. This item is printed on demand. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability.…

Taschenbuch. Condition: Neu. Writing the DSUR | Hafez Selim | Taschenbuch | Englisch | 2026 | Selim Medical Press | EAN 9798235528840 | Verantwortliche Person für die EU: Libri GmbH, Europaallee 1, 36244 Bad Hersfeld, gpsr[at]libri[dot]de | Anbieter: preigu Print on Demand.

Taschenbuch. Condition: Neu. When Medicines Harm | Hafez Selim | Taschenbuch | Englisch | 2026 | Dr. Hafez Selim MD, PhD | EAN 9798235219847 | Verantwortliche Person für die EU: Libri GmbH, Europaallee 1, 36244 Bad Hersfeld, gpsr[at]libri[dot]de | Anbieter: preigu Print on Demand.

Taschenbuch. Condition: Neu. Signal Management in Pharmacovigilance | From Detection and Validation to Benefit-Risk Decisions and Regulatory Action | Hafez Selim | Taschenbuch | Englisch | 2026 | Selim Medical Press | EAN 9798182786652 | Verantwortliche Person für die EU: Libri GmbH, Europaallee 1, 36244 Bad Hersfeld, gpsr[at]libri[dot]de | Anbieter: preigu Print on Demand. …

Taschenbuch. Condition: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -Every periodic safety report ends with one sentence: the benefit-risk balance of the product remains favourable. This book is about how to earn it.Practical Benefit-Risk Assessment in Pharmacovigilance answers the question that guidance documents leave open: you have the efficacy and safety data, so how do you actually decide Across 33 chapters in seven parts, it follows the reasoning from a safety signal, through the structured qualitative frameworks, into quantitative analysis, and on to the regulatory documents where the conclusion has to be written down and defended.Part I sets out the concepts, evidence sources and uncertainty that underlie every assessment. Part II covers the frameworks regulators expect: the FDA Benefit-Risk Framework, the EMA effects table, PrOACT-URL and BRAT. Part III turns to quantitative methods - number needed to treat and number needed to harm, incremental net benefit, multi-criteria decision analysis with swing weighting, one-way and probabilistic sensitivity analysis, and Bayesian approaches. Part IV applies them across the product lifecycle, from first signal evaluation to periodic benefit-risk evaluation reports, risk management plans, development safety update reports and label changes. Later parts address special populations, communication, governance and the failure modes that recur in real assessments.One fictional medicine, Therapex, runs through the whole book. Every method is applied to the same dataset and the same clinical question, so the reader can see where two methods agree, where they diverge, and why. Each method chapter follows the same spine: the concept, the mathematics, a worked example, how to present the result, how to interpret it, its limitations, when to use it, and how to communicate it to a committee or a regulator.The book includes ten worked case studies, twenty-eight figures, four appendices of reference material and wording templates, and an interactive companion workbench that reproduces the calculators used in the text.It is grounded in CIOMS Working Group XII, ICH E2C(R2) and ICH E22, the FDA benefit-risk guidance, the EMA good pharmacovigilance practice modules, the IMI PROTECT roadmap and ISPOR good practices for quantitative benefit-risk assessment, and it is written by a physician-scientist whose career spans drug safety, clinical development and medical device regulation.Written for safety physicians, pharmacovigilance scientists, regulatory affairs and clinical development professionals, benefit-risk and epidemiology groups, and graduate students in pharmacoepidemiology and regulatory science.Foreword by Lisa Beth Ferstenberg, MD. 658 pp. Englisch.…

Taschenbuch. Condition: Neu. Hyperbaric Oxygen Therapy for Diabetic Foot Ulcers | Safety, Effectiveness, Patient Selection, and Clinical Limitations | Hafez Selim | Taschenbuch | Englisch | 2026 | Dr. Hafez Selim MD, PhD | EAN 9798237887198 | Verantwortliche Person für die EU: preigu GmbH & Co. KG, Lengericher Landstr. 19, 49078 Osnabrück, mail[at]preigu[dot]de | Anbieter: preigu Print on Demand. …

Taschenbuch. Condition: Neu. This item is printed on demand - Print on Demand Titel. Neuware -Every periodic safety report ends with one sentence: the benefit-risk balance of the product remains favourable. This book is about how to earn it.Practical Benefit-Risk Assessment in Pharmacovigilance answers the question that guidance documents leave open: you have the efficacy and safety data, so how do you actually decide Across 33 chapters in seven parts, it follows the reasoning from a safety signal, through the structured qualitative frameworks, into quantitative analysis, and on to the regulatory documents where the conclusion has to be written down and defended.Part I sets out the concepts, evidence sources and uncertainty that underlie every assessment. Part II covers the frameworks regulators expect: the FDA Benefit-Risk Framework, the EMA effects table, PrOACT-URL and BRAT. Part III turns to quantitative methods - number needed to treat and number needed to harm, incremental net benefit, multi-criteria decision analysis with swing weighting, one-way and probabilistic sensitivity analysis, and Bayesian approaches. Part IV applies them across the product lifecycle, from first signal evaluation to periodic benefit-risk evaluation reports, risk management plans, development safety update reports and label changes. Later parts address special populations, communication, governance and the failure modes that recur in real assessments.One fictional medicine, Therapex, runs through the whole book. Every method is applied to the same dataset and the same clinical question, so the reader can see where two methods agree, where they diverge, and why. Each method chapter follows the same spine: the concept, the mathematics, a worked example, how to present the result, how to interpret it, its limitations, when to use it, and how to communicate it to a committee or a regulator.The book includes ten worked case studies, twenty-eight figures, four appendices of reference material and wording templates, and an interactive companion workbench that reproduces the calculators used in the text.It is grounded in CIOMS Working Group XII, ICH E2C(R2) and ICH E22, the FDA benefit-risk guidance, the EMA good pharmacovigilance practice modules, the IMI PROTECT roadmap and ISPOR good practices for quantitative benefit-risk assessment, and it is written by a physician-scientist whose career spans drug safety, clinical development and medical device regulation.Written for safety physicians, pharmacovigilance scientists, regulatory affairs and clinical development professionals, benefit-risk and epidemiology groups, and graduate students in pharmacoepidemiology and regulatory science.Foreword by Lisa Beth Ferstenberg, MD. 658 pp. Englisch.…

Taschenbuch. Condition: Neu. Practical Benefit-Risk Assessment in Pharmacovigilance | From Safety Signals to Regulatory Decisions | Hafez Selim | Taschenbuch | Englisch | 2026 | Selim Medical Press | EAN 9798182775823 | Verantwortliche Person für die EU: preigu GmbH & Co. KG, Lengericher Landstr. 19, 49078 Osnabrück, mail[at]preigu[dot]de | Anbieter: preigu Print on Demand. …