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Chapter 1 Introduction
Chapter 2 History of Regenerative Medicine
Chapter 3 Unique Properties of Regenerative Medicines: Key Differences From Small Molecules and Non-Regenerative Biologics
Chapter 4 Combination Products and Regenerative Medicine
Chapter 5 Special Considerations for Gene Therapy
Chapter 6 Gene Therapy and Viral Vectors: An Overview on Current Trends
Chapter 7 Special Considerations for Cell-Based Advanced Therapies
Chapter 8 Establishing Manufacturing Controls: A Hurdle for the Cell and Gene Therapy Industry
Chapter 9 Distribution of Regenerative Medicines
Chapter 10 Regulation of Regenerative Medicines in the US
Chapter 11 Understanding the Regulatory Framework for Regenerative Medicines in the European Union and the United Kingdom
Chapter 12 Regulation of Cell and Gene Therapies in Canada
Chapter 13 Regulation of Regenerative Medicines in Japan
Chapter 14 Cell and Gene Therapy Product Regulation in China
Chapter 15 Regulation of Regenerative Medicines in Australia and New Zealand
Chapter 16 Regulatory Environment of Cell, Tissue, and Gene Therapy Products in Singapore
Chapter 17 The Future of Regenerative Medicine
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.