Regulation of Regenerative Medicines: A Global Perspective

Member: $145.00 Nonmember: $200.00
Regulation of Regenerative Medicines: A Global Perspective

Table of Contents


Lead Editors

Jocelyn Jennings, MS, RAC (US, Drugs, Devices) and William Sietsema, PhD

Product Description

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.

Who should buy this book?

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.

The publication of this first book addressing global regulation of regenerative medicines marks a seminal moment in the evolution of the regenerative medicine industry. By compiling all the relevant information in one place, this text becomes and timely and compulsory reference for all working in the field. I expect that it will contribute mightily to the further advancement and availability of this important class of therapies by facilitating thoughtful interaction between regulators and developers.
David J. Mazzo, PhD
President and CEO, Caladrius Biosciences, Inc.

Special Offer

To purchase both the paperback and e-book versions, add either item to your cart, then select the other format listed under "Optionally select from the following items:" at a discounted rate on the next screen. Note, discount is only available when purchasing both versions in the same transaction.
Published by RAPS © 2022. Paperback. 238 pages. ISBN: 978-1-947493-77-3.

Related books you may be interested in:

Add Book to Cart Add E-book to Cart

Discover more of what matters to you

Biologics Biotechnology Chemistry, Manufacturing and Controls (CMC) Combination Products Global Pharmaceuticals Preclinical study Product Lifecycle Supply Chain Management

News »