LEADER 04742nam 22005775 450 001 9910298453303321 005 20200630065113.0 010 $a3-319-18618-3 024 7 $a10.1007/978-3-319-18618-4 035 $a(CKB)3710000000476903 035 $a(EBL)4178234 035 $a(SSID)ssj0001583885 035 $a(PQKBManifestationID)16265599 035 $a(PQKBTitleCode)TC0001583885 035 $a(PQKBWorkID)14865565 035 $a(PQKB)10856559 035 $a(DE-He213)978-3-319-18618-4 035 $a(MiAaPQ)EBC4178234 035 $a(PPN)19053155X 035 $a(EXLCZ)993710000000476903 100 $a20150915d2015 u| 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aRegulatory Aspects of Gene Therapy and Cell Therapy Products $eA Global Perspective /$fedited by Maria Cristina Galli, Mercedes Serabian 205 $a1st ed. 2015. 210 1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2015. 215 $a1 online resource (235 p.) 225 1 $aAmerican Society of Gene & Cell Therapy,$x2626-7713 ;$v871 300 $aDescription based upon print version of record. 311 $a3-319-18617-5 320 $aIncludes bibliographical references at the end of each chapters and index. 327 $a1. 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). 330 $aMedical literature for health care practitioners on the evaluation and treatment of breastfeeding issues has been disjointed, conflicting, and difficult to find. The field of breastfeeding medicine itself is nonexistent?there are no "breastfeeding doctors" who are specifically trained to understand this complex and interactive process. While much of the literature about breastfeeding describes how it "should" work, there is currently nothing available to explain why it often fails and how to treat it. Clinician?s Guide to Breastfeeding: Evidence-based Evaluation and Management is written for health care practitioners who work with breastfeeding mothers; physicians, nurses, nurse practitioners, and lactation consultants. It provides clear information and clinically tested strategies to help professionals guide new mothers to breastfeed successfully. The first of its kind to consider the entirety of the breastfeeding experience, Clinician?s Guide to Breastfeeding is written by Dr. Linda D. Dahl, a leading expert on the subject. It is a comprehensive review of breastfeeding, covering objective analyses of ideal or ?normal? nursing, as well as the evaluation and treatment of abnormal nursing, including case studies to illustrate the treatment decision-making process. 410 0$aAmerican Society of Gene & Cell Therapy,$x2626-7713 ;$v871 606 $aGene therapy 606 $aGene Therapy$3https://scigraph.springernature.com/ontologies/product-market-codes/B12020 615 0$aGene therapy. 615 14$aGene Therapy. 676 $a616.042 702 $aGalli$b Maria Cristina$4edt$4http://id.loc.gov/vocabulary/relators/edt 702 $aSerabian$b Mercedes$4edt$4http://id.loc.gov/vocabulary/relators/edt 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910298453303321 996 $aRegulatory Aspects of Gene Therapy and Cell Therapy Products$92526666 997 $aUNINA