کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2578769 | 1130013 | 2015 | 12 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Creating Conditions for the Success of The French Industrial Advanced Therapy Sector
ترجمه فارسی عنوان
ایجاد شرایط برای موفقیت صنایع پیشرفته صنعت فرانسوی
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کلمات کلیدی
hCRPCICEFsIndustrial transferNIHCNRSCTPANSMINSERMGLPAFMDGOSC4cCtaALEEMCEPSAP-HPARIISERDFGMOCTAGMPSATTAMDANRPIAEMASMBHCBCeA - CEAiPS - IPSMIG - MEADI - NAMEEuropean Medicines agency - آژانس دارویی اروپاgenetically modified organism - ارگانیزم اصلاح شده ژنتیکیGenetically modified organisms - ارگانیسم های اصلاح شده ژنتیکیUniversity hospital - بیمارستان دانشگاهÉtablissement français du sang - تاسیس خون فرانسهAdvanced therapy medicinal products - داروهای پیشرفته داروییMarket access - دسترسی به بازارinduced pluripotent cells - سلول های تکامل یافته القا شده استage-related macular degeneration - سن تخریب ماکولا مربوط به سن استLes Entreprises du Médicament - شرکت های داروییNational Institutes of Health - مؤسسات ملی بهداشتCAR - ماشینMarketing authorization - مجوز بازاریابیICH - منInstitut National de la Santé et de la Recherche Médicale - موسسه ملی بهداشت و تحقیقات پزشکیDirection générale de l’offre de soins - وزارت بهداشت، درمان و آموزش پزشکیChu - چوClinical trial - کارآزمایی بالینیInternational Conference on Harmonization - کنفرانس بین المللی هماهنگیchimeric antigen receptor - گیرنده آنتی ژنهای کرومیک
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
فارماکولوژی، سم شناسی و اقلام دارویی (عمومی)
چکیده انگلیسی
Although the European Union merely followed the initiatives of the United States and Japan by introducing special regimes for orphan medicinal products, it has introduced a special status for a new category of biological medicinal products, advanced therapy medicinal products (ATMPs), adopting specific associated regulations. European Regulation (which constitutes the highest legal instrument in the hierarchy of European law texts) [EC] No. 1394/2007, published in 2007, uses this term to define somatic cell therapy medicinal products, tissue-engineered products, and gene therapy medicinal products, possibly combined with medical devices. The stated objective was two-fold: both to promote their industrialization and market access, while guaranteeing a high level of health protection for patients. Since publication of the regulation, few marketing authorizations have been granted in Europe, and these have not been accompanied by commercial success. However, certain recent studies show that this is a growing sector and that France remains the leading European nation in terms of clinical trials. This round table brought together a panel of representatives of French public and private protagonists from the advanced therapy sector. The discussions focused on the conditions to ensure the success of translational research and, more generally, the French advanced therapy sector. These enabled a number of obstacles to be identified, which once lifted, by means of recommendations, would facilitate the development and success of this sector.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Thérapie - Volume 70, Issue 1, JanuaryâFebruary 2015, Pages 83-94
Journal: Thérapie - Volume 70, Issue 1, JanuaryâFebruary 2015, Pages 83-94
نویسندگان
Pierre Noel Lirsac, Olivier Blin, Jérémy Magalon, participants of round table N°5 of Giens XXX: participants of round table N°5 of Giens XXX:, Pierre Angot, Estelle de Barbeyrac, Pascal Bilbault, Elisabeth Bourg, Odile Damour, Patrick Faure,