12 ileri kurs1 - Kan Merkezleri ve Transfüzyon Derneği
12 ileri kurs1 - Kan Merkezleri ve Transfüzyon Derneği
12 ileri kurs1 - Kan Merkezleri ve Transfüzyon Derneği
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Ulusal <strong>Kan</strong> <strong>Merkezleri</strong> <strong>ve</strong> <strong>Transfüzyon</strong> T›bb› Kursu XII - ‹leri Kurs<br />
Ruhsatland›rma Sürecinde Karar ‹çin Kullan›lan ‹fl Ak›fl›<br />
‹ncelenen Ürün<br />
hangisidir<br />
KAYNAKLAR<br />
1. D›rect›<strong>ve</strong> 2001/83/Ec Of The European Parl›ament And Of The Counc›l Of 6 No<strong>ve</strong>mber 2001 On The Commun›ty<br />
Code Relat›ng To medicinal Products For Human Use.<br />
2. (EC) No: 1394/2007 of the European Parl›ament and of the Counc›l of NOVEMBER 2007 on advanced therapy<br />
medicinal products and amending Directi<strong>ve</strong> 2001/83/EC and Regulation (EC) No 726/2004).<br />
3. ‹nsan Doku <strong>ve</strong> Hücrelerinin Ba¤›fllanma, Tedarik, Test Etme, ‹fllenme, Korunma, Saklanma <strong>ve</strong> Da¤›t›m Aflamalar›n›n<br />
Gü<strong>ve</strong>nlik <strong>ve</strong> Kalite Standartlar›n› Belirlemeye ‹liflkin 31 Mart 2004 tarih 2004/23/EC SAYILI AVRUPA PAR-<br />
LAMENTOSU VE KONSEY‹ D‹REKT‹F‹.<br />
4. European Medicines Agency. The manufacture and quality control of human somatik cell therapy medicinal product.<br />
Comittee for proprietary medicinal products (CPMP). 2001.<br />
5. DMP Wall, HM Prince. Regulation of Cellular Therapies:The Australian perspecti<strong>ve</strong>, Cytotherapy(2003) Vol.5<br />
No:4,284-288.<br />
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