Regulation of Regenerative Medicines: A Global Perspective

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Regulation of Regenerative Medicines: A Global Perspective takes a comprehensive look inside the unique regulatory frameworks for cell therapy, gene therapy, and tissue engineering in the US and other key world markets, including Australia, Canada, China, Europe, Japan, and Singapore. RAPS latest release is the first compendium of its kind to focus primarily on the rapidly evolving regenerative medicine landscape, encompassing human cells, tissues, and cellular and tissue-based products (HCT/Ps) and advanced therapy medicinal products (ATMPs). Written by dozens of global experts, this resource captures important elements of regenerative medicine regulations in all the regions where frameworks have been or are being established and addresses procedures used in each country, and specifically, how to prepare for meetings with regulators and health authorities.

Regulation of Regenerative Medicines is divided into three distinct sections. Section I contains general information about regenerative medicines from definitions to the unique properties of regenerative medicines. Section II discusses special considerations for cell therapy, gene therapy, tissue engineering, manufacturing concepts, and distribution challenges. Section III covers the unique regulatory frameworks in multiple global regions, including Australia, Canada, China, Europe, Japan, Singapore, and the US, and looks forward to the future of regenerative medicine.

Regulation of Regenerative Medicines: A Global Perspective provides expert guidance to help navigate this rapidly evolving landscape, insight into the complex regulatory frameworks and procedures in specific countries, and impact of regenerative medicines as treatment options for rare diseases, liquid tumor cancers, and even more common disorders. The book also includes specialty areas, such as manufacturing, supply chain, distribution, expectations for pharmacology, pharmacokinetics, toxicology, and combination products as well as important elements to develop regulatory strategy and improve regulatory operations.

Regulatory professionals at all levels of RAPS Regulatory Competency Framework will benefit from different aspects of this book. Regulatory professionals at Levels 1 and 2 of the framework will be able to easily access relevant regenerative medicine 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 comprehensive resource with valuable insight into critical issues facing the regulation of cell therapy, gene therapy, and tissue engineering as well as global aspects of relevant laws and guidance. 

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Published by RAPS © 2022. Paperback. 238 pages. ISBN: 978-1-947493-77-3.