Rakuten Kobo

Shopping Cart

Item(s) unavailable for purchase

Please review your cart. You can remove the unavailable item(s) now or we'll automatically remove it at Checkout.

itemsitem

- Unlimited access to eBooks
  
  Unlimited access to audiobooks
  
  No commitment, cancel anytime at kobo.com/account/subscriptions
  
  Get 1 credit every month for the audiobook of your choice
  
  No commitment, cancel anytime at kobo.com/account/subscriptions
  
  Unlimited access to eBooks
  
  Unlimited access to audiobooks
  
  No commitment, cancel anytime at kobo.com/account/subscriptions
  Audiobook
  by ,
  
  Available:
  
  . No commitment, cancel anytime at kobo.com/account/subscriptions.
  
  Pre-order
  1 audiobook monthly
  
  + FREE 30-day trial
  
  Special Offer
  
  Get 1 credit every month to exchange for an audiobook of your choice
  
  *No commitment, cancel anytime
  
  FREE

itemsitem

Unlimited access to eBooks

Unlimited access to audiobooks

No commitment, cancel anytime at kobo.com/account/subscriptions

Get 1 credit every month for the audiobook of your choice

No commitment, cancel anytime at kobo.com/account/subscriptions

Unlimited access to eBooks

Unlimited access to audiobooks

No commitment, cancel anytime at kobo.com/account/subscriptions
Audiobook
by ,

Available:
. No commitment, cancel anytime at kobo.com/account/subscriptions.

Pre-order
1 audiobook monthly

+ FREE 30-day trial

Special Offer

Get 1 credit every month to exchange for an audiobook of your choice

*No commitment, cancel anytime

FREE

Recommended For You

Skip side bar filters

From Verbatim to Signal

by 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 ... Read more

$39.99 USD or Free with 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
... Read more
Every Turn Matters

by 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 ... Read more

$6.99 USD or Free with 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
... Read more
Mastering the ICSR

by 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 ... Read more

$24.99 USD or Free with 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
... Read more
Understanding Berberine

by 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 ... Read more

$6.99 USD or Free with 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
... Read more
Writing the DSUR

by 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 ... Read more

$39.99 USD or Free with 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
... Read more
When Medicines Harm

by 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 ... Read more

$12.99 USD or Free with 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
... Read more
Write It Right: A Practical Guide to Medical Device Regulatory Writing

by 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 ... Read more

$19.99 USD or Free with 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
... Read more
Faces of Love

Hafez and the Poets of Shiraz (Penguin Classics Deluxe Edition)

Translated by Dick Davis ...

by Hafez, Jahan Malek Khatun, Obayd-e Zakani ...

Series series Penguin Classics Deluxe Edition
Acclaimed translator Dick Davis breathes new life into the timeless works of three masters of 14th-century Persian literatureTogether, Hafez, a giant of world literature; Jahan Malek Khatun, an eloquent princess; and Obayd-e Zakani, a dissolute satirist, represent one of the most remarkable literary flowerings of any era. All three lived in the famed city of Shiraz, a provincial capital of south ... Read more

$13.99 USD

Acclaimed translator Dick Davis breathes new life into the timeless works of three masters of 14th-century Persian literatureTogether, Hafez, a giant of world literature; Jahan Malek Khatun, an eloquent princess; and Obayd-e Zakani, a dissolute satirist, represent one of the most remarkable literary flowerings of any era. All three lived in the famed city of Shiraz, a provincial capital of south
... Read more
Safety and Effectiveness Profiles of Bone Grafts and Bone Graft Substitutes: A Comprehensive Clinical, Scientific, and Regulatory Guide

by 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 ... Read more

$29.99 USD or Free with 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
... Read more
Signal Management in Medical Device Vigilance: From Complaints and Trends to Risk File Updates and Field Safety Action

by 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 ... Read more

$29.99 USD or Free with 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
... Read more
Signal Management in Pharmacovigilance: From Detection and Validation to Benefit–Risk Decisions and Regulatory Action

by 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 ... Read more

$29.99 USD or Free with 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
... Read more
God's constitution

دستور الله

by Mahmoud Hafez ...

God’s Constitution descriptions.The meaning of religion.What does religion consist of?The true Meaning of unification.Jurisprudential shariah standardsWhat is the Believe.The Right Act. --> Worship. (Testimony, Prayer. Zakat, Fasting. Hajj) and Transaction. (Inheritance. Economy. Texas. Politics. Social. Feeding. The oath. Hunting. Act....)Knowing of Last day., but not the hour.The punishment of ... Read more

$3.99 USD or Free with Kobo Plus

God’s Constitution descriptions.The meaning of religion.What does religion consist of?The true Meaning of unification.Jurisprudential shariah standardsWhat is the Believe.The Right Act. --> Worship. (Testimony, Prayer. Zakat, Fasting. Hajj) and Transaction. (Inheritance. Economy. Texas. Politics. Social. Feeding. The oath. Hunting. Act....)Knowing of Last day., but not the hour.The punishment of
... Read more

Rakuten Kobo

eReaders

Apps

Accessories

What is Kobo Super Points?

Reward Yourself

Shopping Cart

You're getting the VIP treatment!

Your Shopping Cart is empty

Available:

1 audiobook monthly

+ FREE 30-day trial

Available:

1 audiobook monthly

+ FREE 30-day trial

Recommended For You

Top Series in United States

Everyman's Library Contemporary Classics Series

Penguin Classics Deluxe Edition

Reading the City

Medicine (R0)

Public Cultures of the Middle East and North Africa

Medicine (R0)

Critical Media Studies: Institutions, Politics, and Culture

Religion and Global Politics

From Verbatim to Signal

Every Turn Matters

Mastering the ICSR

Understanding Berberine

Writing the DSUR

When Medicines Harm

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

Faces of Love

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

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

God's constitution

eReaders

Apps

Accessories

Shopping Cart

You're getting the VIP treatment!

Your Shopping Cart is empty

Available:

1 audiobook monthly

+ FREE 30-day trial

Available:

1 audiobook monthly

+ FREE 30-day trial

Recommended For You

Top Series in United States

Everyman's Library Contemporary Classics Series

Penguin Classics Deluxe Edition

Reading the City

Medicine (R0)

Public Cultures of the Middle East and North Africa

Medicine (R0)

Critical Media Studies: Institutions, Politics, and Culture

Religion and Global Politics

Show: