Regulatory Aspects of Gene Therapy and Cell Therapy Products : A Global Perspective /

Detalles Bibliográficos
Autor Corporativo: SpringerLink (Online service)
Otros Autores: Galli, Maria Cristina. (Editor ), Serabian, Mercedes. (Editor )
Formato: eBook
Lenguaje:English
Publicado: Cham : Springer International Publishing : Imprint: Springer, 2015.
Edición:1st ed. 2015.
Colección:American Society of Gene & Cell Therapy, 871
Materias:
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020 |a 9783319186184 
024 7 |a 10.1007/978-3-319-18618-4  |2 doi 
040 |a Sistema de Bibliotecas del Tecnológico de Costa Rica 
245 1 0 |a Regulatory Aspects of Gene Therapy and Cell Therapy Products :  |b A Global Perspective /  |c edited by Maria Cristina Galli, Mercedes Serabian. 
250 |a 1st ed. 2015. 
260 # # |a Cham :  |b Springer International Publishing :  |b Imprint: Springer,  |c 2015. 
300 |a XII, 230 p. 23 illus., 17 illus. in color. :  |b online resource. 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
490 1 |a American Society of Gene & Cell Therapy,  |v 871 
505 0 |a 1. Regulatory Oversight of Gene Therapy and Cell Therapy Products in the US - FDA/CBER -- 2. US Oversight of Gene Therapy Products – NIH RAC -- 3. Regulatory Oversight of Gene Therapy and Cell Therapy Products in Canada - Health Canada -- 4. Overview of the Regulatory Oversight Implemented by the French Regulatory Authorities for the Clinical Investigation of Gene Therapy and Cell Therapy Products -- 5. Regulation of Clinical Trials with Advanced Therapy Medicinal Products (ATMP) in Germany -- 6. EU Clinical Trials Regulatory Oversight of Advanced Therapy Medicinal Products (ATMP): Perspectives from Various Member States -- 7. Regulatory Oversight of Gene Therapy and Cell Therapy Products in Switzerland - Swissmedic -- 8. Regulatory Oversight of Gene Therapy and Cell Therapy Products in Japan - Japan Ministry of Health, Labour and Welfare (MHLW) and Pharmaceutical and Medical Device Agency (PMDA) -- 9. Regulatory Oversight of Gene Therapy and Cell Therapy Products in Korea - Korean Ministry of Food and Drug Safety (MFDS) -- 10. Regulatory Oversight of Gene Therapy and Cell Therapy Products in Taiwan - Taiwan Food and Drug Administration (TFDA) -- 11. Regulatory Oversight of Gene Therapy and Cell Therapy Products in Singapore - Singapore Health Science Authorities (HSA) -- 12. Regulatory Oversight of Gene Therapy and Cell Therapy Products in Brazil - National Health Surveillance Agency (ANVISA). 
650 0 |a Gene therapy. 
650 1 4 |a Gene Therapy. 
700 1 |a Galli, Maria Cristina.  |e editor. 
700 1 |a Serabian, Mercedes.  |e editor. 
710 2 |a SpringerLink (Online service) 
773 0 |t Springer eBooks