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Regulatory aspects of gene therapy and cell therapy products : a global perspective

Author: Maria Cristina Galli; Mercedes Serabian; American Society of Gene & Cell Therapy,
Publisher: Cham [Switzerland] : Springer, [2015]
Series: Advances in experimental medicine and biology, 871.
Edition/Format:   eBook : Document : EnglishView all editions and formats
Database:WorldCat
Summary:
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 nonexistentℓ́ℓthere 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"  Read more...
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Genre/Form: Electronic books
Additional Physical Format: Printed edition:
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Maria Cristina Galli; Mercedes Serabian; American Society of Gene & Cell Therapy,
ISBN: 9783319186184 3319186183 3319186175 9783319186177
OCLC Number: 921302091
Description: 1 online resource.
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).
Series Title: Advances in experimental medicine and biology, 871.
Responsibility: Maria Cristina Galli, Mercedes Serabian, editors.
More information:

Abstract:

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 nonexistentℓ́ℓthere 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. Clinicianℓ́ℓs Guide to Breastfeeding: Evidence-based Evaluation and Management℗ℓis 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, ℗ℓClinicianℓ́ℓs Guide to Breastfeeding℗ℓis 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 ℓ́ℓnormalℓ́ℓ nursing, as well as the evaluation and treatment of abnormal nursing, including case studies to illustrate the treatment decision-making process.

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