Regulatory aspects of gene therapy and cell therapy products: a global perspective
Gespeichert in:
Weitere Verfasser: | |
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Format: | Buch |
Sprache: | English |
Veröffentlicht: |
Cham
Springer
[2023]
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Ausgabe: | Second edition |
Schriftenreihe: | Advances in experimental medicine and biology
volume 1430 |
Schlagworte: | |
Online-Zugang: | Inhaltsverzeichnis |
Beschreibung: | Includes bibliographical references |
Beschreibung: | ix, 242 Seiten Illustrationen 26 cm |
ISBN: | 9783031345661 |
Internformat
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Datensatz im Suchindex
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adam_text | Contents 1 2 Marketing Regulatory Oversight of Advanced Therapy Medicinal Products in Europe.................................. Martina Schuessler-Lenz, Carla Herberts, Ilona Reischl, Sol Ruiz, Patrick Celis, Claire Beuneu, Rune Kjeken, and Marcos Timón Clinical Trials on Advanced Therapy Investigational Medicinal Products in Spain (2004-2022): Experience and Challenges for the Future................................................... Juan Estévez Álamo, Marcos Timón, 1 23 Isabel Sánchez Afán de Rivera, Beatriz Iriarte Torres, and M. Antonia Serrano Castro 3 The Regulation of Cell Therapy and Gene Therapy Products in Switzerland.............................................................. Petra Kempná Bukovac, Michel Hauser, Daniel Lottaz, 41 Andreas Marti, Iris Schmitt, and Thomas Schochat 4 European Pharmacopoeia’s Approach to Cell and Gene Therapy: Focus on How Gene Therapy Texts Are Evolving.... 59 Olga Kolaj-Robin and Marie-Thérèse Duffour 5 United States Food and Drug Administration Regulation of Human Cells, Tissues, and Gene Therapies........................ 71 Sandhya Sanduja, Liz Lessey-Morillon, Rondine Allen, Xiaofei Wang, Gavin Imperato, and Judith Arcidiacono 6 7 Canadian Regulatory Framework and Regulatory Requirements for Cell and Gene Therapy Products............. Jian Wang, Emily Griffiths, Omar Tounekti, Martin Nemec, Eric Deneault, Jessie R. Lavoie, and Anthony Ridgway 91 Advanced Therapy Products in Brazil: Regulatory Aspects.... 117 João Batista Silva Junior, Renata Miranda Parca, and Adriana Bastos Carvalho 8 Regulation of Clinical Research for
Cellular and Gene Therapy Products in India............................................................ 135 Varsha Dalal, Hem Lata, Gitika Kharkwal, and Geeta Jotwani vii
viii 9 Regulatory Aspects of Cell and Gene Therapy Products: The Japanese Perspective.......................................................... 155 Yoshiaki Maruyama, Shinichi Noda, Shinichi Okudaira, Akira Sakurai, Narumi Okura, and Futaba Honda 10 Regulatory Oversight of Cell and Gene Therapy Products in Malaysia .............................................................. 181 Evelyn Yun Xi Loh, Azizah Ab Ghani, and Rosilawati Ahmad 11 Regulatory Oversight of Cell, Tissue, and Gene Therapy Products in Singapore.............................................................. 197 Lee Lee Ong 12 Update on Regulation of Regenerative Medicine in Taiwan.... 211 Wan-Yu Chao, Yi-Ting Chang, Yueh-Tung Tsai, Mei-Chen Huang, Yi-Chu Lin, Min-Mei Wu, Jo-Feng Chi, Chien-Liang Lin, Hwei-Fang Cheng, and Shou-Mei Wu 13 Regulatory Frameworks for Advanced Therapy Medicinal Products in Thailand............................................ 221 Piyanan Boonprasirt, Sarun Nimvorapun, Chonticha Sawangjang, Sitanun Poonpolsub, Worasuda Yoongthong, and Paišam Dunkum 14 International Harmonization for Cell and Gene Therapy Products.................................................................... 235 Judith Arcidiacono Index...................................................................................................... 241
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Contents 1 2 Marketing Regulatory Oversight of Advanced Therapy Medicinal Products in Europe. Martina Schuessler-Lenz, Carla Herberts, Ilona Reischl, Sol Ruiz, Patrick Celis, Claire Beuneu, Rune Kjeken, and Marcos Timón Clinical Trials on Advanced Therapy Investigational Medicinal Products in Spain (2004-2022): Experience and Challenges for the Future. Juan Estévez Álamo, Marcos Timón, 1 23 Isabel Sánchez Afán de Rivera, Beatriz Iriarte Torres, and M. Antonia Serrano Castro 3 The Regulation of Cell Therapy and Gene Therapy Products in Switzerland. Petra Kempná Bukovac, Michel Hauser, Daniel Lottaz, 41 Andreas Marti, Iris Schmitt, and Thomas Schochat 4 European Pharmacopoeia’s Approach to Cell and Gene Therapy: Focus on How Gene Therapy Texts Are Evolving. 59 Olga Kolaj-Robin and Marie-Thérèse Duffour 5 United States Food and Drug Administration Regulation of Human Cells, Tissues, and Gene Therapies. 71 Sandhya Sanduja, Liz Lessey-Morillon, Rondine Allen, Xiaofei Wang, Gavin Imperato, and Judith Arcidiacono 6 7 Canadian Regulatory Framework and Regulatory Requirements for Cell and Gene Therapy Products. Jian Wang, Emily Griffiths, Omar Tounekti, Martin Nemec, Eric Deneault, Jessie R. Lavoie, and Anthony Ridgway 91 Advanced Therapy Products in Brazil: Regulatory Aspects. 117 João Batista Silva Junior, Renata Miranda Parca, and Adriana Bastos Carvalho 8 Regulation of Clinical Research for
Cellular and Gene Therapy Products in India. 135 Varsha Dalal, Hem Lata, Gitika Kharkwal, and Geeta Jotwani vii
viii 9 Regulatory Aspects of Cell and Gene Therapy Products: The Japanese Perspective. 155 Yoshiaki Maruyama, Shinichi Noda, Shinichi Okudaira, Akira Sakurai, Narumi Okura, and Futaba Honda 10 Regulatory Oversight of Cell and Gene Therapy Products in Malaysia . 181 Evelyn Yun Xi Loh, Azizah Ab Ghani, and Rosilawati Ahmad 11 Regulatory Oversight of Cell, Tissue, and Gene Therapy Products in Singapore. 197 Lee Lee Ong 12 Update on Regulation of Regenerative Medicine in Taiwan. 211 Wan-Yu Chao, Yi-Ting Chang, Yueh-Tung Tsai, Mei-Chen Huang, Yi-Chu Lin, Min-Mei Wu, Jo-Feng Chi, Chien-Liang Lin, Hwei-Fang Cheng, and Shou-Mei Wu 13 Regulatory Frameworks for Advanced Therapy Medicinal Products in Thailand. 221 Piyanan Boonprasirt, Sarun Nimvorapun, Chonticha Sawangjang, Sitanun Poonpolsub, Worasuda Yoongthong, and Paišam Dunkum 14 International Harmonization for Cell and Gene Therapy Products. 235 Judith Arcidiacono Index. 241 |
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spelling | Regulatory aspects of gene therapy and cell therapy products a global perspective Maria Cristina Galli (editor) Second edition Cham Springer [2023] ix, 242 Seiten Illustrationen 26 cm txt rdacontent n rdamedia nc rdacarrier Advances in experimental medicine and biology volume 1430 Includes bibliographical references Gene therapy Government policy Cellular therapy Government policy Medical policy Clinical trials (DE-588)4143413-4 Aufsatzsammlung gnd-content Galli, Maria Cristina 1966- (DE-588)123447143 edt Erscheint auch als Online-Ausgabe 978-3-031-34567-8 Advances in experimental medicine and biology volume 1430 (DE-604)BV000003102 1430 Digitalisierung UB Passau - ADAM Catalogue Enrichment application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=034364619&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
spellingShingle | Regulatory aspects of gene therapy and cell therapy products a global perspective Advances in experimental medicine and biology Gene therapy Government policy Cellular therapy Government policy Medical policy Clinical trials |
subject_GND | (DE-588)4143413-4 |
title | Regulatory aspects of gene therapy and cell therapy products a global perspective |
title_auth | Regulatory aspects of gene therapy and cell therapy products a global perspective |
title_exact_search | Regulatory aspects of gene therapy and cell therapy products a global perspective |
title_exact_search_txtP | Regulatory aspects of gene therapy and cell therapy products a global perspective |
title_full | Regulatory aspects of gene therapy and cell therapy products a global perspective Maria Cristina Galli (editor) |
title_fullStr | Regulatory aspects of gene therapy and cell therapy products a global perspective Maria Cristina Galli (editor) |
title_full_unstemmed | Regulatory aspects of gene therapy and cell therapy products a global perspective Maria Cristina Galli (editor) |
title_short | Regulatory aspects of gene therapy and cell therapy products |
title_sort | regulatory aspects of gene therapy and cell therapy products a global perspective |
title_sub | a global perspective |
topic | Gene therapy Government policy Cellular therapy Government policy Medical policy Clinical trials |
topic_facet | Gene therapy Government policy Cellular therapy Government policy Medical policy Clinical trials Aufsatzsammlung |
url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=034364619&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
volume_link | (DE-604)BV000003102 |
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