Essentials of Healthcare Product Labeling, Second Edition
Table of Contents
Chapter 1: Introduction to Healthcare Product Labeling
Chapter 2: Content Development
Chapter 3: Content Development – Special Considerations for Medical Devices
Chapter 4: Core Labeling
Chapter 5: Pharmaceutical Labeling in the US
Chapter 6: Patient Labeling in the US
Chapter 7: EU Product Information
Chapter 8: Labeling of Human Drugs in Canada
Chapter 9: Labeling of Nonprescription Human Drugs in Canada
Chapter 10: Plain Language Labeling
Chapter 11: Medical Device Labeling in the US
Chapter 12: EU Labeling for Medical Devices and In Vitro Diagnostic Medical Devices
Chapter 13: Canadian Labeling for Medical Devices and In Vitro Diagnostic Devices
Chapter 14: Operational Considerations
Chapter 15: US Submissions and Launch Activities
Chapter 16: EU Submissions and Launch Activities
Chapter 17: Target Product Profiles and Target Labeling
Chapter 18: Investigational Drug Labeling
Chapter 19: Labeling and Packaging of Cannabis Products
Cathleen O’Connell, PHD, MS, RPH, editor
About the Book
Available formats: print and e-book.
The second edition of Essentials of Healthcare Product Labeling explores the critical role of labeling in the use of healthcare products and spotlights the ever-evolving dynamics behind the creation of effective product information. Industry experts from around the world contributed real-world insight across 19 chapters, with refreshed content on topics such as investigational labeling and the packaging and labeling of cannabis products. Anchored in general concepts with informative guidance on special issues and complexities within the labeling function, this detailed reference offers practical interpretation of prevailing guidelines, links to relevant resources, and clarification of best practices.
Essentials of Healthcare Product Labeling, Second Edition, illuminates the processes, relationships, and challenges involved throughout the labeling development lifecycle. The refined and updated material takes a deeper look into the needs of specific users and how to drive improvements to create effective, quality labeling that supports the success of healthcare products across different product categories and different regions.
Who will benefit from this book?
Regulatory experts and healthcare professionals will find value in Essentials of Healthcare Product Labeling, Second Edition, as the text covers a variety of information that will be useful to not only those who design and implement labeling but also to those who administer and use healthcare products. This book was developed for anyone new to labeling operations as well as for seasoned professionals looking to better comprehend the responsibilities and processes behind label creation.
Regulatory professionals at Levels 1 and 2 of the RAPS Regulatory Competency Framework will appreciate the foundational content in each chapter and the convenient collection of resources and references for further study. Regulatory professionals at Levels 3 and 4 can regard the text as an authoritative resource on labeling project management, risk considerations, and compliance strategy.
Purchasing Options
This book can be purchased in the following formats:
- Digital e-book. Single purchase; accessible online via RAPS Library online reader and downloadable.
- Printed book.
This book can also be purchased as part of the following bundles:
- All Access Library (12-month digital subscription)
Published by RAPS © 2023. Paperback. 228 pages. ISBN (print): 978-1-947493-91-9. ISBN (digital): 978-1-947493-92-6.
