Coverart for item
The Resource Regulatory aspects of gene therapy and cell therapy products : a global perspective, Maria Cristina Galli, Mercedes Serabian, editors

Regulatory aspects of gene therapy and cell therapy products : a global perspective, Maria Cristina Galli, Mercedes Serabian, editors

Label
Regulatory aspects of gene therapy and cell therapy products : a global perspective
Title
Regulatory aspects of gene therapy and cell therapy products
Title remainder
a global perspective
Statement of responsibility
Maria Cristina Galli, Mercedes Serabian, editors
Contributor
Editor
Issuing body
Subject
Language
eng
Member of
Cataloging source
BTCTA
Dewey number
616.042
Illustrations
illustrations
Index
index present
LC call number
RB155.8
LC item number
.R44 2015
Literary form
non fiction
Nature of contents
bibliography
NLM call number
QU 560
NLM item number
.R344 2015
http://library.link/vocab/relatedWorkOrContributorName
  • Galli, Maria Cristina
  • Serabian, Mercedes
  • American Society of Gene & Cell Therapy
Series statement
  • Advances in Experimental Medicine and Biology,
  • American Society of Gene & Cell Therapy
Series volume
871.
http://library.link/vocab/subjectName
  • Gene therapy
  • Gene therapy
  • Cell- and Tissue-Based Therapy
  • Genetic Therapy
  • Government Regulation
  • Legislation, Medical
  • Translational Medical Research
Label
Regulatory aspects of gene therapy and cell therapy products : a global perspective, Maria Cristina Galli, Mercedes Serabian, editors
Instantiates
Publication
Copyright
Bibliography note
Includes bibliographical references and index
Carrier category
volume
Carrier category code
nc
Carrier MARC source
rdacarrier.
Content category
text
Content type code
txt
Content type MARC source
rdacontent.
Contents
United States Food and Drug Administration regulation of gene and cell therapies / Alexander M. Bailey, Judith Arcidiacono, Kimberly A. Benton, Zenobia Taraporewala, and Steve Winitsky -- 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, and Jacqueline Corrigan-Curay -- Regulatory oversight of cell and gene therapy products in Canada / Anthony Ridgway, Francisca Agbanyo, Jian Wang, and Michael Rosu-Myles -- 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, and Jean-Hughes Trouvin -- Regulation of clinical trials with advanced therapy medicinal products in Germany / Matthias Renner, Brigitte Anliker, Ralf Sanzenbacher, and Silke Schuele --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, Margaret Menendez-Ferreira, egbert Flory, Matthias Renner, and Nicolas Ferry -- Requriements for clinical trials with gene therapy and transplant products in Switzerland / Andreas Marti -- Regulatory frameworks for gene and cell therapies in Japan / Daisuke Maeda, Teruhide Yamaguchi, Takami Ishizuka, Masakazu Hirata, Kazuhiro Takekita, and Daisaku Sato -- Regulatory oversight of gene therapy and cell therapy products in Korea / Minjoung Choi, Euiri Han, Sunmi Lee, Taegyun Kim, and Won Shin -- 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, Shiow-Ing Wu, Yu-Mei Chiang, and Li-Ling Liu -- Regulatory oversight of cell- and tissue-based therapeutic products and gene therapy products in Singapore / Choon Wee Goh, Srinivasan N. Kellathur, Lee Lee Ong, and Xiaofeng Wu -- The regulatory pathway for advanced cell therapy and gene therapy products in Brazil: a road to be built / Daniel Roberto Coraldi de freitas -- Index
Control code
907205373
Dimensions
24 cm
Extent
xii, 230 pages
Isbn
9783319186177
Lccn
2015946741
Media category
unmediated
Media MARC source
rdamedia.
Media type code
n
Other physical details
illustrations (some color)
System control number
(OCoLC)907205373
Label
Regulatory aspects of gene therapy and cell therapy products : a global perspective, Maria Cristina Galli, Mercedes Serabian, editors
Publication
Copyright
Bibliography note
Includes bibliographical references and index
Carrier category
volume
Carrier category code
nc
Carrier MARC source
rdacarrier.
Content category
text
Content type code
txt
Content type MARC source
rdacontent.
Contents
United States Food and Drug Administration regulation of gene and cell therapies / Alexander M. Bailey, Judith Arcidiacono, Kimberly A. Benton, Zenobia Taraporewala, and Steve Winitsky -- 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, and Jacqueline Corrigan-Curay -- Regulatory oversight of cell and gene therapy products in Canada / Anthony Ridgway, Francisca Agbanyo, Jian Wang, and Michael Rosu-Myles -- 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, and Jean-Hughes Trouvin -- Regulation of clinical trials with advanced therapy medicinal products in Germany / Matthias Renner, Brigitte Anliker, Ralf Sanzenbacher, and Silke Schuele --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, Margaret Menendez-Ferreira, egbert Flory, Matthias Renner, and Nicolas Ferry -- Requriements for clinical trials with gene therapy and transplant products in Switzerland / Andreas Marti -- Regulatory frameworks for gene and cell therapies in Japan / Daisuke Maeda, Teruhide Yamaguchi, Takami Ishizuka, Masakazu Hirata, Kazuhiro Takekita, and Daisaku Sato -- Regulatory oversight of gene therapy and cell therapy products in Korea / Minjoung Choi, Euiri Han, Sunmi Lee, Taegyun Kim, and Won Shin -- 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, Shiow-Ing Wu, Yu-Mei Chiang, and Li-Ling Liu -- Regulatory oversight of cell- and tissue-based therapeutic products and gene therapy products in Singapore / Choon Wee Goh, Srinivasan N. Kellathur, Lee Lee Ong, and Xiaofeng Wu -- The regulatory pathway for advanced cell therapy and gene therapy products in Brazil: a road to be built / Daniel Roberto Coraldi de freitas -- Index
Control code
907205373
Dimensions
24 cm
Extent
xii, 230 pages
Isbn
9783319186177
Lccn
2015946741
Media category
unmediated
Media MARC source
rdamedia.
Media type code
n
Other physical details
illustrations (some color)
System control number
(OCoLC)907205373

Library Locations

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      38.939544 -92.328377
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