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Regulatory aspects of gene therapy a...

Galli, Maria Cristina.

Regulatory aspects of gene therapy and cell therapy productsa global perspective /

Record Type:	Electronic resources : Monograph/item
Title/Author:	Regulatory aspects of gene therapy and cell therapy productsedited by Maria Cristina Galli, Mercedes Serabian.
Reminder of title:	a global perspective /
other author:	Galli, Maria Cristina.
Published:	Cham :Springer International Publishing :2015.
Description:	xii, 230 p. :ill., digital ;24 cm.
Contained By:	Springer eBooks
Subject:	Gene therapyGovernment policy.
Online resource:	http://dx.doi.org/10.1007/978-3-319-18618-4
ISBN:	9783319186184$q(electronic bk.)

Regulatory aspects of gene therapy and cell therapy productsa global perspective /
Regulatory aspects of gene therapy and cell therapy productsa global perspective /[electronic resource] :edited by Maria Cristina Galli, Mercedes Serabian. - Cham :Springer International Publishing :2015. - xii, 230 p. :ill., digital ;24 cm. - Advances in experimental medicine and biology,v.8710065-2598 ;. - Advances in experimental medicine and biology ;946..

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)

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.

ISBN: 9783319186184$q(electronic bk.)

Standard No.: 10.1007/978-3-319-18618-4doiSubjects--Topical Terms:

730862
Gene therapy
--Government policy.

LC Class. No.: RB155.8

Dewey Class. No.: 616.042

Regulatory aspects of gene therapy and cell therapy productsa global perspective /
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245 0 0 $a Regulatory aspects of gene therapy and cell therapy products $h [electronic resource] : $b a global perspective / $c edited by Maria Cristina Galli, Mercedes Serabian.
260 $a Cham : $b Springer International Publishing : $b Imprint: Springer, $c 2015.
300 $a xii, 230 p. : $b ill., digital ; $c 24 cm.
490 1 $a Advances in experimental medicine and biology, $x 0065-2598 ; $v 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)
520 $a 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.
650 0 $a Gene therapy $x Government policy. $3 730862
650 0 $a Gene therapy $x Law and legislation. $3 730863
650 1 4 $a Biomedicine. $3 273648
650 2 4 $a Gene Therapy. $3 196467
700 1 $a Galli, Maria Cristina. $3 730860
700 1 $a Serabian, Mercedes. $3 730861
710 2 $a SpringerLink (Online service) $3 273601
773 0 $t Springer eBooks
830 0 $a Advances in experimental medicine and biology ; $v 946. $3 557559
856 4 0 $u http://dx.doi.org/10.1007/978-3-319-18618-4
950 $a Biomedical and Life Sciences (Springer-11642)