Regulation of regenerative medicines: a global perspective

& (eds.)
Rockville: Regulatory Affairs Professionals Society (2022)
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Abstract

Regulation of Regenerative Medicines: A Global Perspective covers regenerative medicine regulations globally where frameworks have been or are being established. Chapters by discipline include manufacturing, supply chain, pharmacology, pharmacokinetics, toxicology, and combination product.

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K3611.G46.R44 2022

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9781947493773   1947493779

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Chapters

Cell and Gene Therapy Product Regulation in China.Yingying Liu, Linxi Wu Murphy Mao & Anette Hjelmsmark
Combination Products and Regenerative Medicine.Jocelyn Jennings
Distribution of Regenerative Medicines.Andrea Zobel
Establishing Manufacturing Controls : A Hurdle for the Cell and Gene Therapy Industry.Mo Heidaran
Gene Therapy and Viral Vectors : An Overview on Current Trends.Marites T. Woon & Rajesh L. Thangapazham
History of Regenerative Medicine.Karen M. Hauda, Stephen Westover & Grant S. Griffin
Introduction.Jocelyn Jennings
Regulation of Cell and Gene Therapies in Canada.Aileen J. Zhou
Regulation of Regenerative Medicines in Australia and New Zealand.Orin Chisholm
Regulation of Regenerative Medicines in Japan.Tomoki Yokoyama & Brett Snyder
Regulation of Regenerative Medicines in the US.Stephen Westover & William Sietsema
Regulatory Environment of Cell, Tissue, and Gene Therapy Products in Singapore.Stefanie Fasshauer
Special Considerations for Cell-Based Advanced Therapies.Bridget Bulwer, Mo Heidaran & Darin J. Weber
Special Considerations for Gene Therapy.Kristin Van Goor, Snehal Naik & Dylan Bechtle
The Future of Regenerative Medicine.Kristin Van Goor, Dylan Bechtle, Snehal Naik & Rasika Kalameghan
Understanding the Regulatory Framework for Regenerative Medicines in the European Union and the United Kingdom.Christiane Niederlaender
Unique Properties of Regenerative Medicines : Key Differences From Small Molecules and Non-Regenerative Biologics.David Litwack

Similar books and articles

Combination Products and Regenerative Medicine.Jocelyn Jennings - 2022 - In William Sietsema & Jocelyn Jennings (eds.), Regulation of regenerative medicines: a global perspective. Rockville: Regulatory Affairs Professionals Society.
The Future of Regenerative Medicine.Kristin Van Goor, Dylan Bechtle, Snehal Naik & Rasika Kalameghan - 2022 - In William Sietsema & Jocelyn Jennings (eds.), Regulation of regenerative medicines: a global perspective. Rockville: Regulatory Affairs Professionals Society.
History of Regenerative Medicine.Karen M. Hauda, Stephen Westover & Grant S. Griffin - 2022 - In William Sietsema & Jocelyn Jennings (eds.), Regulation of regenerative medicines: a global perspective. Rockville: Regulatory Affairs Professionals Society.
Regulation of Regenerative Medicines in Japan.Tomoki Yokoyama & Brett Snyder - 2022 - In William Sietsema & Jocelyn Jennings (eds.), Regulation of regenerative medicines: a global perspective. Rockville: Regulatory Affairs Professionals Society.
Regulation of Regenerative Medicines in the US.Stephen Westover & William Sietsema - 2022 - In William Sietsema & Jocelyn Jennings (eds.), Regulation of regenerative medicines: a global perspective. Rockville: Regulatory Affairs Professionals Society.
Distribution of Regenerative Medicines.Andrea Zobel - 2022 - In William Sietsema & Jocelyn Jennings (eds.), Regulation of regenerative medicines: a global perspective. Rockville: Regulatory Affairs Professionals Society.
Regulation of Regenerative Medicines in Australia and New Zealand.Orin Chisholm - 2022 - In William Sietsema & Jocelyn Jennings (eds.), Regulation of regenerative medicines: a global perspective. Rockville: Regulatory Affairs Professionals Society.
Introduction.Jocelyn Jennings - 2022 - In William Sietsema & Jocelyn Jennings (eds.), Regulation of regenerative medicines: a global perspective. Rockville: Regulatory Affairs Professionals Society.
Cell and Gene Therapy Product Regulation in China.Yingying Liu, Linxi Wu Murphy Mao & Anette Hjelmsmark - 2022 - In William Sietsema & Jocelyn Jennings (eds.), Regulation of regenerative medicines: a global perspective. Rockville: Regulatory Affairs Professionals Society.
Unique Properties of Regenerative Medicines : Key Differences From Small Molecules and Non-Regenerative Biologics.David Litwack - 2022 - In William Sietsema & Jocelyn Jennings (eds.), Regulation of regenerative medicines: a global perspective. Rockville: Regulatory Affairs Professionals Society.

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