المؤلفون: V. A. Orlov, V. N. Shestakov

المصدر: Разработка и регистрация лекарственных средств, Vol 9, Iss 2, Pp 151-158 (2020)

مصطلحات موضوعية: надлежащая производственная практика, gmp, уполномоченные лица, pic/s, еаэс, ema, фбу «гилс и нп», несоответствия, отклонения, инспектирование, качество, лекарственное средство, регуляторный орган, гармонизация, риск, дефект качества, Pharmaceutical industry, HD9665-9675

وصف الملف: electronic resource

Relation: https://www.pharmjournal.ru/jour/article/view/768; https://doaj.org/toc/2305-2066; https://doaj.org/toc/2658-5049

URL الوصول: https://doaj.org/article/ca10a68187354b89a1be7474c883a9d7

المؤلفون: Mohsen Dehghan-Dehnavi, Rasoul Dinarvand, Mohammad Reza Khoshayand, Fatemeh Kia, Mohammad Shahab Maghazei, Farid A. Dorkoosh

المصدر: Journal of Pharmacoeconomics and Pharmaceutical Management, Vol 1, Iss 1/2 (2015)

مصطلحات موضوعية: Master Validation Plan, Iranian Pharmaceutical Industries, PIC/s, cGMP, FDA, VMP, Pharmacy and materia medica, RS1-441

وصف الملف: electronic resource

Relation: https://jppm.tums.ac.ir/index.php/jppm/article/view/8; https://doaj.org/toc/2383-4498

URL الوصول: https://doaj.org/article/b89643fc70524d9385a0bfd51e614fd6

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المؤلفون: Shinya Yamanaka, Kentaro Azuma

المصدر: Regenerative Therapy

مصطلحات موضوعية: 0301 basic medicine, Engineering, ESC, embryonic stem cell, RMP, regenerative medicine product, AMED, Japan Agency for Medical Research and Development, J-MACS, Japanese Registry for Mechanically Assisted Circulatory Support, Review Article, R&D, research and development, MEXT, Ministry of Education, Culture, Sports, Science and Technology, Regenerative medicine, GMP, good manufacturing practice, Japan, Agency (sociology), GCTP, Good Gene, Cell, Cellular and Tissue-based Products Manufacturing Practice, Haplobank, Induced pluripotent stem cell, Riken CDB, Riken Center for Developmental Biology, RM Act, the Act on the Safety of Regenerative Medicine, Medical research, PMD Act, Pharmaceuticals and Medical Devices Act, CiRA, Center for iPS Cell Research and Application, 3. Good health, iPS cells, Policy, Risk analysis (engineering), MHLW, Ministry of Health, Labour and Welfare, NEDO, New Energy and Industrial Technology Development Organization, Research center, Regulation, iPSC, induced pluripotent stem cell, IRB, Institutional Review Board, PAL, Pharmaceutical Affairs Law, INTERMACS, Interagency Registry for Mechanically Assisted Circulatory Support, GAiT, Global Alliance for iPS Cell Therapies, Biomedical Engineering, Harmonization, WHO, World Health Organization, Biomaterials, JST, Japan Science and Technology Agency, 03 medical and health sciences, NIBIO, National Institute of Biomedical Innovation, IBRI, Institution of Biomedical Research and Innovation, Global network, FY, fiscal year, Operations management, IND, Investigational New Drug, ICH, The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, NIHS, National Institute of Health Science, Funding Agency, HLA, human leukocyte antigen, business.industry, PMDA, Pharmaceuticals and Medical Devices Agency, FDA, Food and Drug Administration, BLA, Biological License Approval, 030104 developmental biology, CFR, Code of Federal Regulations, METI, Ministry of Economy, Trade and Industry, U.S., United States, LVAD, left ventricular assist device, PIC/S, The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme, business, DMF, Drug Master File, Developmental Biology

وصف الملف: application/pdf

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b1957840a9fc1e64016dea9e17fb6c65
http://hdl.handle.net/2433/242857

المؤلفون: Svensk, Elin, Lång, Josefin

مصطلحات موضوعية: Medicin och hälsovetenskap, diabetes, Pacific Island countries (PIC´s), activity, participation, Medical and Health Sciences, Developing countries, prostheses

وصف الملف: application/pdf

URL الوصول: https://explore.openaire.eu/search/publication?articleId=dedup_wf_001::9d52b7994bede278f3b198566ff7b993
http://urn.kb.se/resolve?urn=urn:nbn:se:hj:diva-40468

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المؤلفون: Somying Pumtong

مصطلحات موضوعية: Good Manufacturing Practice, GMP, Pharmaceutical Inspection Cooperation Scheme, PIC/S

URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_________::7efdfa5e7e59b9b8c27dc96069afb088

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