International Combination Products (e-book)
Table of Contents
Section I: General Information
Chapter 1 What are Combination Products?
Chapter 2 Regulatory Strategy
Section II: North America: US and Canada
Chapter 3 US FDA Structure, Office of Combination Products, and Combination Products Policy Council
Chapter 4 Jurisdiction and Regulatory Pathway
Chapter 5 Combination Product Development and Meetings
Chapter 6 Investigational Use and Human Factors
Chapter 7 Current Good Manufacturing Practice (CGMP
Chapter 8 Marketing Applications, Premarket Review Pathways, and User Fees
Chapter 9 Combination Product Review Process and Labeling
Chapter 10 Postapproval Modifications
Chapter 11 Postmarket Safety Reporting
Chapter 12 Canadian Combination Products
Section III: Europe
Chapter 13 European Union Combination Products
Jocelyn Jennings, MS, RAC-US, RAC-Drugs, RAC-Devices, editor
About the Book
Available formats: print and e-book
Combination products and their development can seem particularly complex if the regulatory foundation that underpins them is not clear. RAPS new topical book, International Combination Products, provides an in-depth look at this breakthrough field and covers three major regulatory regions: the US, Canada, and Europe.
International Combination Products provides practical guidance on navigating this exciting area of converging technologies. Combination products raise a variety of developmental, testing and regulatory challenges due to their unique melding of regulatory identities. The complexities grow even more so when innovative technologies, such as wearable products or artificial intelligence, are combined with drugs or biologics.
This book includes background information and practical guidelines regarding regulatory questions of these novel technologies. It takes a readily applicable approach to addressing the relevant challenges associated with merging technologies. This book explores the process from start to finish, establishing a workable regulatory strategy to bring the products to the market in a compliant and timely manner.
International Combination Products emphasizes the importance of ensuring the best possible products are delivered as swiftly as possible, but never forgetting the scientific rigor and regulatory oversight that ultimately determine failure or success.
Who will benefit from this book?
International Combination Products was developed for regulatory professionals of all levels that either currently work on combination products or will be working on combination products. The book also provides insights for research and development subject matter experts. No matter how steeped one is in combination products and their various regulations in different geographical areas, this valuable resource provides updated information as well as new insights. For those starting their career in this exciting field, this book will serve as a vital source for knowledge and action.
Combination products and their development can seem particularly complex if the regulatory foundation that underpins the concept is not elucidated. This new book is a resource for regulatory professionals and the industry that explores the regulatory framework of combination products and provides practical guidance on navigating this exciting area of converging technologies. Jocelyn Jennings, MS, RAC (US, Drugs, Devices)
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 © 2021. Paperback. 180 pages. ISBN (print): 978-1-947493-59-9. ISBN (digital): 978-1-947493-60-5.
