Regulatory Aspects of Gene Therapy and Cell Therapy Products : A Global Perspective / / edited by Maria Cristina Galli, Mercedes Serabian

• Pubblicazione: Cham : , : Springer International Publishing : , : Imprint : Springer, , 2015
• Edizione: 1st ed. 2015.
• Descrizione fisica: 1 online resource (235 p.)
• Disciplina: 616.042
• Soggetto topico: Gene therapy; Gene Therapy
• Persona (resp. second.): GalliMaria Cristina; SerabianMercedes
• Note generali: Description based upon print version of record.
• Nota di bibliografia: Includes bibliographical references at the end of each chapters and index.
• Nota di contenuto: 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).
• Sommario/riassunto: Medical literature for health care practitioners on the evaluation and treatment of breastfeeding issues has been disjointed, conflicting, and difficult to find. The field of breastfeeding medicine itself is nonexistent—there are no "breastfeeding doctors" who are specifically trained to understand this complex and interactive process. While much of the literature about breastfeeding describes how it "should" work, there is currently nothing available to explain why it often fails and how to treat it. Clinician’s Guide to Breastfeeding: Evidence-based Evaluation and Management is written for health care practitioners who work with breastfeeding mothers; physicians, nurses, nurse practitioners, and lactation consultants. It provides clear information and clinically tested strategies to help professionals guide new mothers to breastfeed successfully. The first of its kind to consider the entirety of the breastfeeding experience, Clinician’s Guide to Breastfeeding is written by Dr. Linda D. Dahl, a leading expert on the subject. It is a comprehensive review of breastfeeding, covering objective analyses of ideal or “normal” nursing, as well as the evaluation and treatment of abnormal nursing, including case studies to illustrate the treatment decision-making process.
• Titolo autorizzato: Regulatory Aspects of Gene Therapy and Cell Therapy Products
• ISBN: 3-319-18618-3
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910298453303321
• Lo trovi qui: Univ. Federico II
• Serie: American Society of Gene & Cell Therapy, . 2626-7713 ; ; 871