VSE knjižnice (vzajemna bibliografsko-kataložna baza podatkov COBIB.SI)
  • Challenges with advanced therapy medicinal products and how to meet them
    Schneider, Christian ...
    Advanced therapy medicinal products (ATMPs), which include gene therapy medicinal products, somatic cell therapy medicinal products and tissue-engineered products, are at the cutting edge of ... innovation and offer a major hope for various diseases for which there are limited or no therapeutic options. They have therefore been subject to considerable interest and debate.Following the European regulation on ATMPs, a consolidated regulatory framework for these innovative medicines has recently been established. Central to this framework is the Committee for Advanced Therapies (CAT) at theEuropean Medicines Agency (EMA), comprising a multidisciplinary scientific expert committee, representing all EU member states and European Free Trade Association countries, as well as patient and medical associations. In this article, the CAT discusses some of the typical issues raised by developers of ATMPs, and highlights the opportunities for such companies and research groupsto approach the EMA and the CAT as a regulatory advisor during development.
    Vir: Nature reviews. Drug discovery. - ISSN 1474-1776 (Letn. 9, št. 3, 2010, str. 195-201)
    Vrsta gradiva - članek, sestavni del
    Leto - 2010
    Jezik - angleški
    COBISS.SI-ID - 26685401
    DOI

vir: Nature reviews. Drug discovery. - ISSN 1474-1776 (Letn. 9, št. 3, 2010, str. 195-201)
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