Regulatory aspects of gene therapy and cell therapy products : a global perspective / Maria Cristina Galli, Mercedes Serabian, editors.
2015
K3611.G46 R44 2015 (Map It)
Available at Cellar
Formats
| Format | |
|---|---|
| BibTeX | |
| MARCXML | |
| TextMARC | |
| MARC | |
| DublinCore | |
| EndNote | |
| NLM | |
| RefWorks | |
| RIS |
Items
Details
Title
Regulatory aspects of gene therapy and cell therapy products : a global perspective / Maria Cristina Galli, Mercedes Serabian, editors.
Published
Cham : Springer ; [Milwaukee, Wis.] : American Society of Gene & Cell Therapy, [2015]
Copyright
©2015
Call Number
K3611.G46 R44 2015
ISBN
9783319186177 (hardback ; alkaline paper)
3319186175 (hardback ; alkaline paper)
9783319186184 (electronic book)
3319186183 (electronic book)
3319186175 (hardback ; alkaline paper)
9783319186184 (electronic book)
3319186183 (electronic book)
Description
xii, 230 pages : illustrations (some color) ; 24 cm.
System Control No.
(OCoLC)907205373
Bibliography, etc. Note
Includes bibliographical references and index.
Series
Available in Other Form
Online version: Regulatory aspects of gene therapy and cell therapy products. Cham [Switzerland] : Springer, [2015] 9783319186184 (OCoLC)921302091
Record Appears in
Added Corporate Author
Table of Contents
United States Food and Drug Administration Regulation of Gene and Cell Therapies / Steve Winitsky
1
National Institutes of Health Oversight of Human Gene Transfer Research: Enhancing Science and Safety / Jacqueline Corrigan-Curay
31
Regulatory Oversight of Cell and Gene Therapy Products in Canada / Michael Rosu-Myles
49
Overview of the Regulatory Oversight Implemented by the French Regulatory Authorities for the Clinical Investigation of Gene Therapy and Cell Therapy Products / Jean-Hugues Trouvin
73
Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany / Silke Schuele
87
Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective / Nicolas Ferry
103
Requirements for Clinical Trials with Gene Therapy and Transplant Products in Switzerland / Andreas Marti
131
Regulatory Frameworks for Gene and Cell Therapies in Japan / Daisaku Sato
147
Regulatory Oversight of Gene Therapy and Cell Therapy Products in Korea / Won Shin
163
Regulation of Cell and Gene Therapy Medicinal Products in Taiwan / Li-Ling Liu
181
Regulatory Oversight of Cell- and Tissue-Based Therapeutic Products and Gene Therapy Products in Singapore / Xiaofeng Wu
195
Regulatory Pathway for Advanced Cell Therapy and Gene Therapy Products in Brazil: A Road to Be Built / Daniel Roberto Coradi de Freitas
213
Index
221