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International Combination Products

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International Combination Products

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Lead Editor

Jocelyn Jennings, MS, RAC (US, Drugs, Devices)

Product Description

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 should buy 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)

Published by RAPS © 2021. Paperback. 180 pages. ISBN: 978-1-947493-59-9.

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