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Benefit-Risk Assessment of Medicines

The Development and Application of a Universal Framework for Decision-Making and Effective Communication

Authors: Leong, James, Salek, Sam, Walker, Stuart

  • Examines current approaches for the benefit-risk assessment of medicines and the acceptability of a “universal framework” by regulatory agencies and pharmaceutical companies
  • Presents the development and implementation of a template for documenting benefit-risk decisions in a structured systematic transparent manner
  • Reviews the strategies of major regulatory authorities (US FDA, EMA, Australia and Health Canada) for communicating benefit-risk decisions to stakeholders and how they can be improved using the newly developed B-R template
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Buy this book

eBook 51,16 €
price for Spain (gross)
  • ISBN 978-3-319-15805-1
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover 62,39 €
price for Spain (gross)
  • ISBN 978-3-319-15804-4
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
  • The final prices may differ from the prices shown due to specifics of VAT rules
Softcover 62,39 €
price for Spain (gross)
  • ISBN 978-3-319-36767-5
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
  • The final prices may differ from the prices shown due to specifics of VAT rules
About this book

This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox.

Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a structured, systematic, standardized approach. Examining the evaluation of such an approach by several mature regulatory authorities ensures that the reader gains a unique insight into the ongoing debate in this area.

The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is reflected in the recent FDA PUDFA agreement as well as in the EMA 2015 Roadmap. Rather than provide a comprehensive snap-shot of this constantly changing environment, this book evaluates selected current approaches to benefit-risk assessment. The strengths and weaknesses of publicly available documents in communicating benefit-risk decisions to stakeholders are reviewed and these evaluations are used to inform development of a prospective framework that could be used to harmonise procedures globally.

About the authors

James Leong, BSc Pharm Hons, MClinPharm, PhD, BCPS is a Board certified pharmacist and Head of Education at the Centre of Regulatory Excellence, Duke-NUS Graduate Medical School Singapore. His role focuses on identifying the educational needs for the various stakeholders involved in regulatory affairs in the Asia Pacific region and establishing educational roadmaps, priorities and deliverables. He received his PhD in regulatory sciences from Cardiff University, UK.

Sam Salek PhD RPh FFPM MRPSGB MCMS FESCP is Professor of Pharmacoepidemiology at the University of Hertfordshire, Hatfield, visiting Professor at the Estate of Hessen, Germany, and Director of the Institute for Medicines Development, Cardiff, UK. Professor Salek’s research focuses on mainly four areas including: development and application of patient-reported outcome measures; drug safety evaluation and pharmacovigilance; pharmacoeconomics and economic evaluation of healthcare; and pharmaceutical regulation and medicines development in the mature and emerging markets. He has published 19 books and 600 journal articles and abstracts. Professor Salek is member of five Editorial Boards and an active member of several societies.

Stuart Walker BSc, PhD, MFPM FRSC FIBiol, FRCPath, is the Founder of the Centre for Medicines Research International, the Centre for Innovation in Regulatory Science and Professor of Pharmaceutical Medicine, University of Wales, Cardiff. During his research career in academia and industry, he has supervised many PhD programmes in clinical development, regulatory policies, the Benefit/Risk Assessment of Medicines and Health Technology Assessment, co-authored 280 research papers and edited twenty-five books. He is frequently involved in the organisation of international meetings on key issues that concern the Regulatory Review of Medicines and has lectured extensively throughout Europe, the United States, the Asia-Pacific Region, Latin America and the Middle East.

Table of contents (8 chapters)

  • Overview

    Leong, James (et al.)

    Pages 1-22

    Preview Buy Chapter 30,19 €
  • Approaches to Utilizing Decision-Making Framework

    Leong, James (et al.)

    Pages 23-31

    Preview Buy Chapter 30,19 €
  • Benefit–Risk Assessment of Medicines by Pharmaceutical Companies and Regulatory Authorities

    Leong, James (et al.)

    Pages 33-68

    Preview Buy Chapter 30,19 €
  • Development of a Universal Benefit–Risk Framework and Template

    Leong, James (et al.)

    Pages 69-143

    Preview Buy Chapter 30,19 €
  • Implementation of the Benefit–Risk Assessment Template by Mature Agencies

    Leong, James (et al.)

    Pages 145-176

    Preview Buy Chapter 30,19 €

Buy this book

eBook 51,16 €
price for Spain (gross)
  • ISBN 978-3-319-15805-1
  • Digitally watermarked, DRM-free
  • Included format: PDF, EPUB
  • ebooks can be used on all reading devices
  • Immediate eBook download after purchase
Hardcover 62,39 €
price for Spain (gross)
  • ISBN 978-3-319-15804-4
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
  • The final prices may differ from the prices shown due to specifics of VAT rules
Softcover 62,39 €
price for Spain (gross)
  • ISBN 978-3-319-36767-5
  • Free shipping for individuals worldwide
  • Usually dispatched within 3 to 5 business days.
  • The final prices may differ from the prices shown due to specifics of VAT rules
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Bibliographic Information

Bibliographic Information
Book Title
Benefit-Risk Assessment of Medicines
Book Subtitle
The Development and Application of a Universal Framework for Decision-Making and Effective Communication
Authors
Copyright
2015
Publisher
ADIS
Copyright Holder
Springer International Publishing Switzerland
eBook ISBN
978-3-319-15805-1
DOI
10.1007/978-3-319-15805-1
Hardcover ISBN
978-3-319-15804-4
Softcover ISBN
978-3-319-36767-5
Edition Number
1
Number of Pages
XIII, 317
Number of Illustrations and Tables
25 b/w illustrations, 138 illustrations in colour
Topics