Regulatory aspects of gene therapy and cell therapy products : a global perspective /: a global perspective. ([2015])

• Record Type: Book
• Further Information: Note: Maria Cristina Galli, Mercedes Serabian, editors.
• Editors: Galli, Maria Cristina; Serabian, Mercedes
• Other Names: American Society of Gene & Cell Therapy, sponsoring body.
• Contents: 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).
• Publisher Details: Cham [Switzerland] : Springer
• Publication Date: 2015
• Extent: 1 online resource
• Subjects: 616.042; Medicine; Gene therapy -- Government policy; Gene therapy -- Law and legislation; HEALTH & FITNESS -- Diseases -- General; MEDICAL -- Clinical Medicine; MEDICAL -- Diseases; MEDICAL -- Evidence-Based Medicine; MEDICAL -- Internal Medicine; Gene therapy -- Government policy; Gene therapy -- Law and legislation; Health & Biological Sciences; Pathology; Medicine; Genetic Therapy; Biomedicine; Gene Therapy; Gene therapy; Medical -- Genetics; Medical genetics; Electronic books
• Languages: English
• ISBNs: 9783319186184; 3319186183; 3319186175; 9783319186177
• Related ISBNs: 9783319186177
• Notes: Note: Includes bibliographical references and index.; Note: Vendor-supplied metadata.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.