Practical Benefit-Risk Assessment in Pharmacovigilance
Published by Selim Medical Press Sep 2026, 2026
- Softcover
- New
Seller: buchversandmimpf2000, Emtmannsberg, BAYE, Germanybuchversandmimpf2000
AbeBooks seller since January 23, 2017
Condition: New
£ 65.26
Quantity: 1 available
Add to basketItem description from seller
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.…
Seller Inventory # 9798182775823
- Title
- Practical Benefit-Risk Assessment in Pharmacovigilance
- Author
- Hafez Selim
- Publisher
- Selim Medical Press Sep 2026
- Publication year
- 2026
- Condition
- Neu
- Binding
- Taschenbuch
- ISBN 13
- 9798182775823
- Item weight
- 1,217 grams
- Dimensions
- 254x178x35 mm
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.
"Synopsis" may belong to another edition of this title.
About the Author
"About the title" may belong to another edition of this title.
buchversandmimpf2000
Emtmannsberg, BAYE, Germany
AbeBooks seller since January 23, 2017
Shipping rates from Germany to U.S.A.
| Item | 60 to 60 business days | 60 to 60 business days |
|---|---|---|
| First item | £ 50.69 | £ 63.36 |
Payment methods
- Check
- Paypal
Store description
Impressum Thorsten Retsch Buchversand Mimpf2000 Oberölschnitz 16 95517 Emtmannsberg Deutschland Telefon: 09209-2023188 Email: mimpf2000@online.de USt-ID-Nr.: DE 235096871 Wir führen gebrauchte Bücher aus allen Sparten der Literatur
Specialty
Modernes Antiquariat - Bücher von 1960 bis heuteSeller's business information
buchversandmimpf2000
Germany
Terms of sale
Impressum
Gesetzliche Anbieterkennung:
Thorsten Retsch
Buchversand Mimpf2000
Oberölschnitz 16
95517 Emtmannsberg
Deutschland
Telefon: 092092023188
E-Mail: order@buchversandmimpf2000.de
USt-IdNr.: DE 235096871
Alternative Streitbeilegung:
Die Europäische Kommission stellt eine Plattform für die außergerichtliche Online-Streitbeilegung (OS-Plattform) bereit, aufrufbar unter http://ec.europa.eu/odr.
Right of withdrawal
If you are a consumer you can withdraw from the contract in accordance with the following. Consumer means any natural person who is acting for purposes which are outside his trade, business, craft or profession.
Information regarding the right of withdrawal
Statutory right to withdraw
You have the right to withdraw from this contract within 14 days without giving any reason.
The withdrawal period will expire after 14 days from the day on which you acquire, or a third party other than the carrier and indicated by you acquires, physical possession of the last good or the last lot or piece.
To exercise the right of withdrawal, electronically fill in and submit a clear statement on our website, under "My Purchases" in "My Account". We will communicate to you an acknowledgement of receipt of such a withdrawal on a durable medium (e.g. by e-mail) without delay.
To meet the withdrawal deadline, it is sufficient for you to send your communication concerning your exercise of the right of withdrawal before the withdrawal period has expired.
Effects of withdrawal
If you withdraw from this contract, we will reimburse to you all payments received from you, including the costs of delivery (except for the supplementary costs arising if you chose a type of delivery other than the least expensive type of standard delivery offered by us).
We may make a deduction from the reimbursement for loss in value of any goods supplied, if the loss is the result of unnecessary handling by you.
We will make the reimbursement without undue delay, and not later than 14 days after the day on which we are informed about your decision to withdraw from this contract.
We will make the reimbursement using the same means of payment as you used for the initial transaction, unless you have expressly agreed otherwise; in any event, you will not incur any fees as a result of such reimbursement.
We may withhold reimbursement until we have received the goods back, or you have supplied evidence of having sent back the goods, whichever is the earliest.
You shall send back the goods or hand them over to buchversandmimpf2000, Emtmannsberg, BAYE, Germany, +49 09209-2023188, without undue delay and in any event not later than 14 days from the day on which you communicate your withdrawal from this contract to us. The deadline is met if you send back the goods before the period of 14 days has expired. You will have to bear the direct cost of returning the goods. You are only liable for any diminished value of the goods resulting from the handling other than what is necessary to establish the nature, characteristics and functioning of the goods.
Exceptions to the right of withdrawal
The right of withdrawal does not apply to:
- The delivery of newspapers, journals or magazines with the exception of subscription contracts; and
- The supply of digital content which is not supplied on a tangible medium (e.g. on a CD or DVD) if you accepted when you placed your order that we could start to deliver it, and that you could not withdraw once delivery had started.
Shipping terms
Soweit in der Artikelbeschreibung keine andere Frist angegeben ist, erfolgt die Lieferung der Ware innerhalb von 3-5 Werktagen nach Vertragsschluss, bei Vorauszahlung erst nach Eingang des vollständigen Kaufpreises und der Versandkosten. Alle Preise inkl. MwSt.