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From Verbatim to Signal

de Hafez Selim ...

Every safety conclusion rests on a chain of small decisions that nobody sees in the final report. A nurse writes "yellow eyes" in a telephone note. A case processor chooses a lowest level term. Months later, a scientist selects a search strategy and a safety team decides whether there is anything to worry about. If one of those decisions is careless, the table can be wrong in a way no statistical ... Leer más

$39.99 USD o gratis con Kobo Plus

Every safety conclusion rests on a chain of small decisions that nobody sees in the final report. A nurse writes "yellow eyes" in a telephone note. A case processor chooses a lowest level term. Months later, a scientist selects a search strategy and a safety team decides whether there is anything to worry about. If one of those decisions is careless, the table can be wrong in a way no statistical
... Leer más
Every Turn Matters

de Hafez Selim, Amor Khachemoune ...

Caring for someone who cannot move well is hard work. Skin care can feel like one more job on a list that never ends. This book makes that job smaller.Every Turn Matters is a plain-language guide for family caregivers. Two doctors — a patient-safety physician and a skin and wound specialist — show you how bedsores start, how to stop them, and what to do the day you find one.You do not need to ... Leer más

$6.99 USD o gratis con Kobo Plus

Caring for someone who cannot move well is hard work. Skin care can feel like one more job on a list that never ends. This book makes that job smaller.Every Turn Matters is a plain-language guide for family caregivers. Two doctors — a patient-safety physician and a skin and wound specialist — show you how bedsores start, how to stop them, and what to do the day you find one.You do not need to
... Leer más
Understanding Berberine

de Hafez Selim ...

Thinking about berberine for your blood sugar? Read this before you buy a bottle.Berberine is everywhere: social media calls it "nature's Ozempic," and store shelves are full of it. But what can it really do for type 2 diabetes, and is it safe with the medicines you already take?Written by a physician and drug safety expert, Understanding Berberine gives patients and caregivers clear, honest ... Leer más

$6.99 USD o gratis con Kobo Plus

Thinking about berberine for your blood sugar? Read this before you buy a bottle.Berberine is everywhere: social media calls it "nature's Ozempic," and store shelves are full of it. But what can it really do for type 2 diabetes, and is it safe with the medicines you already take?Written by a physician and drug safety expert, Understanding Berberine gives patients and caregivers clear, honest
... Leer más
Writing the DSUR

de Hafez Selim ...

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 ... Leer más

$39.99 USD o gratis con Kobo Plus

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
... Leer más
Mastering the ICSR

de Hafez Selim ...

Every adverse event report that reaches a drug safety department becomes an Individual Case Safety Report (ICSR) - and the quality of that case determines whether real safety signals are detected, assessed, and acted on. Mastering the ICSR: Case Processing in Modern Pharmacovigilance is a practical, end-to-end guide to how ICSRs are received, assessed, coded, written, and reported to regulators ... Leer más

$24.99 USD o gratis con Kobo Plus

Every adverse event report that reaches a drug safety department becomes an Individual Case Safety Report (ICSR) - and the quality of that case determines whether real safety signals are detected, assessed, and acted on. Mastering the ICSR: Case Processing in Modern Pharmacovigilance is a practical, end-to-end guide to how ICSRs are received, assessed, coded, written, and reported to regulators
... Leer más
Write It Right: A Practical Guide to Medical Device Regulatory Writing

de Hafez Selim ...

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 ... Leer más

$19.99 USD o gratis con Kobo Plus

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
... Leer más
When Medicines Harm

de Hafez Selim ...

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 ... Leer más

$12.99 USD o gratis con Kobo Plus

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
... Leer más
Signal Management in Medical Device Vigilance: From Complaints and Trends to Risk File Updates and Field Safety Action

de Hafez Selim ...

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 ... Leer más

$29.99 USD o gratis con Kobo Plus

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
... Leer más
Signal Management in Pharmacovigilance: From Detection and Validation to Benefit–Risk Decisions and Regulatory Action

de Hafez Selim ...

A practical, end-to-end guide to pharmacovigilance signal management, from the first statistical alert to the final regulatory decision.Most drug safety texts explain how to find a signal. Far fewer show what happens next: how a signal is validated, prioritized, assessed, weighed against benefit, escalated, and closed with a record that holds up. Signal Management in Pharmacovigilance covers that ... Leer más

$29.99 USD o gratis con Kobo Plus

A practical, end-to-end guide to pharmacovigilance signal management, from the first statistical alert to the final regulatory decision.Most drug safety texts explain how to find a signal. Far fewer show what happens next: how a signal is validated, prioritized, assessed, weighed against benefit, escalated, and closed with a record that holds up. Signal Management in Pharmacovigilance covers that
... Leer más
Safety and Effectiveness Profiles of Bone Grafts and Bone Graft Substitutes: A Comprehensive Clinical, Scientific, and Regulatory Guide

de Dr. Hafez Selim, MD, PhD ...

Which bone graft is best? That is usually the wrong question.The more useful questions are these: which biological and mechanical properties does this particular defect require, does the proposed graft actually supply them, how strong is the evidence behind that claim, and what safety burden comes with it?Safety and Effectiveness Profiles of Bone Grafts and Bone Graft Substitutes offers a ... Leer más

$29.99 USD o gratis con Kobo Plus

Which bone graft is best? That is usually the wrong question.The more useful questions are these: which biological and mechanical properties does this particular defect require, does the proposed graft actually supply them, how strong is the evidence behind that claim, and what safety burden comes with it?Safety and Effectiveness Profiles of Bone Grafts and Bone Graft Substitutes offers a
... Leer más
Practical Benefit–Risk Assessment in Pharmacovigilance From Safety Signals to Regulatory Decisions

de Hafez Selim ...

Every periodic safety report ends with the same sentence: the benefit–risk balance remains favourable. Regulatory guidance is excellent at describing what that conclusion must look like on the page. ICH E2C(R2) tells you where the integrated analysis goes. ICH M4E(R2) sets out the subsection structure. GVP Module V defines which risks belong in the safety specification. The FDA framework gives you ... Leer más

$39.00 USD o gratis con Kobo Plus

Every periodic safety report ends with the same sentence: the benefit–risk balance remains favourable. Regulatory guidance is excellent at describing what that conclusion must look like on the page. ICH E2C(R2) tells you where the integrated analysis goes. ICH M4E(R2) sets out the subsection structure. GVP Module V defines which risks belong in the safety specification. The FDA framework gives you
... Leer más
Write It Right

A Practical Guide to Medical Device Regulatory Writing

de Dr. Hafez Selim MD PhD ...

Regulators and Notified Bodies judge a medical device by what is written about it. Write It Right is a practical guide to producing regulatory and clinical documents that are clear, traceable and defensible, built around EU MDR (Regulation (EU) 2017/745) with reference to the current FDA framework.Written by a physician-scientist who spent nearly a decade in safety leadership at a leading global ... Leer más

$28.49 USD

Regulators and Notified Bodies judge a medical device by what is written about it. Write It Right is a practical guide to producing regulatory and clinical documents that are clear, traceable and defensible, built around EU MDR (Regulation (EU) 2017/745) with reference to the current FDA framework.Written by a physician-scientist who spent nearly a decade in safety leadership at a leading global
... Leer más

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“hafez selim”

From Verbatim to Signal

Every Turn Matters

Understanding Berberine

Writing the DSUR

Mastering the ICSR

Write It Right: A Practical Guide to Medical Device Regulatory Writing

When Medicines Harm

Signal Management in Medical Device Vigilance: From Complaints and Trends to Risk File Updates and Field Safety Action

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

Safety and Effectiveness Profiles of Bone Grafts and Bone Graft Substitutes: A Comprehensive Clinical, Scientific, and Regulatory Guide

Practical Benefit–Risk Assessment in Pharmacovigilance From Safety Signals to Regulatory Decisions

Write It Right

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