Cell-based product classification procedure: What can be done differently to improve decisions on borderline products?
Highlights • Classification of a product as ATMP, transplant or blood component may be challenging. • CAT is usually approached for advice on classification of borderline products. • Product classification has major organizational, economic and regulatory implications. • CAT's criteria to class...
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| Veröffentlicht in: | Cytotherapy (Oxford, England) England), 2016-07, Vol.18 (7), p.809-815 |
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| container_title | Cytotherapy (Oxford, England) |
| container_volume | 18 |
| creator | Izeta, Ander Herrera, Concha Mata, Rosario Astori, Giuseppe Giordano, Rosaria Hernández, Carmen Leyva, Laura Arias, Salvador Oyonarte, Salvador Carmona, Gloria Cuende, Natividad |
| description | Highlights • Classification of a product as ATMP, transplant or blood component may be challenging. • CAT is usually approached for advice on classification of borderline products. • Product classification has major organizational, economic and regulatory implications. • CAT's criteria to classify cell products can impact accessibility and sustainability. • Product classification may benefit from more interaction among competent authorities. |
| doi_str_mv | 10.1016/j.jcyt.2016.03.292 |
| format | Article |
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| source | MEDLINE; Alma/SFX Local Collection |
| subjects | accessibility Advanced Basic Science blood cell transfusion cell transplantation cell-based borderline products cell-based medicinal products classification procedure Decision Making essential functions Humans Other regulation substantial manipulation sustainability Transplants - classification |
| title | Cell-based product classification procedure: What can be done differently to improve decisions on borderline products? |
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