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Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective |
Maria Cristina Galli; Mercedes Serabian
Springer International Publishing
Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective
Regulatory Oversight of Gene Therapy and Cell Therapy Products in Korea
Authors

Minjoung Choi; Euiri Han; Sunmi Lee; Taegyun Kim; Won Shin

ARI Id

1664721504228_2921720

Access

Not Available Free

Pages

163-179

DOI

10.1007/978-3-319-18618-4_9

Chapter URL

https://rd.springer.com/chapter/10.1007/978-3-319-18618-4_9

Table of Contents of Book
Showing 1 to 14 of 14 entries
Chapters/HeadingsAuthor(s)PagesInfo
Front Matter
i-xii
United States Food and Drug Administration Regulation of Gene and Cell Therapies
Alexander M. Bailey; Judith Arcidiacono; Kimberly A. Benton; Zenobia Taraporewala; Steve Winitsky
1-29
The National Institutes of Health Oversight of Human Gene Transfer Research: Enhancing Science and Safety
Marina O’Reilly; Robert Jambou; Eugene Rosenthal; Maureen Montgomery; Morad Hassani; Linda Gargiulo et al.
31-47
Regulatory Oversight of Cell and Gene Therapy Products in Canada
Anthony Ridgway; Francisca Agbanyo; Jian Wang; Michael Rosu-Myles
49-71
Overview of the Regulatory Oversight Implemented by the French Regulatory Authorities for the Clinical Investigation of Gene Therapy and Cell Therapy Products
Sophie Lucas-Samuel; Nicolas Ferry; Jean-Hugues Trouvin
73-85
Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany
Matthias Renner; Brigitte Anliker; Ralf Sanzenbacher; Silke Schuele
87-101
Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective
Paula Salmikangas; Martina Schuessler-Lenz; Sol Ruiz; Patrick Celis; Ilona Reischl; Margarida Menezes-Ferreira et al.
103-130
Requirements for Clinical Trials with Gene Therapy and Transplant Products in Switzerland
Andreas Marti
131-145
Regulatory Frameworks for Gene and Cell Therapies in Japan
Daisuke Maeda; Teruhide Yamaguchi; Takami Ishizuka; Masakazu Hirata; Kazuhiro Takekita; Daisaku Sato
147-162
Regulatory Oversight of Gene Therapy and Cell Therapy Products in Korea
Minjoung Choi; Euiri Han; Sunmi Lee; Taegyun Kim; Won Shin
163-179
Regulation of Cell and Gene Therapy Medicinal Products in Taiwan
Yi-Chu Lin; Po-Yu Wang; Shih-Chih Tsai; Chien-Liang Lin; Hsuen-Yung Tai; Chi-Fang Lo et al.
181-194
Regulatory Oversight of Cell- and Tissue-Based Therapeutic Products and Gene Therapy Products in Singapore
Choon Wee Goh; Srinivasan N. Kellathur; Lee Lee Ong; Xiaofeng Wu
195-212
The Regulatory Pathway for Advanced Cell Therapy and Gene Therapy Products in Brazil: A Road to Be Built
Daniel Roberto Coradi de Freitas
213-219
Back Matter
221-230
Chapters/HeadingsAuthor(s)PagesInfo
Showing 1 to 14 of 14 entries
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