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Our new book is a comprehensive look at a vital part of medicines development and regulatory affairs. Grab your copy today!
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This is an On-demand recording from May 2021
Hear from the expert who wrote the book: International Combination Products
Jocelyn Jennings, MS, RAC (US, Drugs, Devices), a veteran in the combination product regulatory space, will be on hand to answer all your questions on RAPS new topical book, International Combination Products.
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.
International Combination Products 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.
No matter how steeped one is in combination products and their various regulations in different geographical areas, this book 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.
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.