Risk Management Principles for Devices and Pharmaceuticals, Third Edition

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Risk Management Principles for Devices and Pharmaceuticals, Third Edition

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Sample Chapter 


J. Michael Sprafka, MPH, PhD

Product Description

The benefit-risk assessment is a foundation upon which the development of medicinal products and medical devices are built. The process begins – and ends – with identifying, understanding, analyzing, and mitigating the risks of an investigation product. 

Risk Management Principles for Devices and Pharmaceuticals, Third Edition, aims to document the rules and regulations regarding peri- and postmarketing risk management principles and practices, providing readers with the up-to-date information they need as they work to minimize the harms and maximize the help provided by the medicinal products and medical devices they seek to bring to market.

This updated book contains all the practical information of its predecessor, including preclinical, clinical and postmarketing risk evaluation; regional risk management requirements; benefit-risk assessment; pregnancy registry use; and quality risk management. The content is augmented by in-depth case studies that will provide readers with a concrete understanding of how to be a strategic partner on a risk management team within their organizations.

Within its pages, readers will find a greater understanding the regulatory environment of risk management in selected countries throughout the world, enhancing their ability to implement global risk management strategies.

Bonus: Free Book with Every Purchase

Buy this book and receive a complimentary copy of Risk Evaluation and Mitigation Strategies for US Drug Development, Second Edition by Edward Tabor, MD, published by RAPS in 2018. This book contains the history of the US Food and Drug Administration’s REMS program, as well as analysis of numerous guidance documents and policy changes that have modified  EMS development requirements, format and processes.

Who should buy this book?

This book was developed for regulatory professionals of all levels of RAPS Regulatory Competency Framework, including newcomers and seasoned professionals as well as academics and governmental employees. Regulatory professionals at Levels 1 and 2 of the framework will be able to easily access relevant regulations and guidance in specific countries and how to apply them in one convenient place. For more senior professionals at Levels 3 and 4 responsible for global regulatory strategy, the book will serve as a valuable resource to facilitate strategic discussions on regulations and policy worldwide.
Risk management is increasingly complex, with the globalization of requirements; increased availability of data through advanced technology and digitization; and changes to the healthcare delivery system. The complexity and nature of clinical development and postmarket experience require a proactive, systematic, and scientific approach to measuring or assessing risk and developing strategies to manage or mitigate it. This book aims to help readers assess and mitigate risk as they work to bring new medicinal product to market.
Debashish Dey, MD, PhD, MPH

Published by RAPS © 2023. Hardcover. 380 pages. ISBN: 978-1-947493-84-1.

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