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Key aspects to consider for the development of a regulatory framework for the use of cell therapies

Abstract:

S206 Abstracts/Cytotherapy 23 (2021) S17–S207 1413 Regulatory Affairs, Quality Systems, Policy, and Ethics STANDARD REGULATION FOR STEM CELL PRODUCTS IN INDONESIA A. Chouw1, G. Facicilia1, AN Arofah1, MN Kirana1, Y. Dirgantara2, SF Jundan2, Z. Alifah2, CR Sartika2, S. Mutia2 1Quality Assurance, PT Prodia StemCell Indonesia, Jakarta, DKI, Indonesia; 2Laboratory, PT. Prodia Stemcell Indonesia, Jakarta, DKI Jakarta, Denmark. Keywords: GMP, Stem Cell, Regulation. Background & Aim: Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues, or cells. Currently, there has been a constant increase in the number of clinical trials evaluating ATMPs, with a focus on CBMPs, including stem cell–based medicinal products for regenerative medicine. However, the scientific assessment of stem cells product is still challenging from a regulatory …

Año de publicación:

2021

Keywords:

    Fuente:

    googlegoogle

    Tipo de documento:

    Other

    Estado:

    Acceso abierto

    Áreas de conocimiento:

      Áreas temáticas:

      • Medicina forense; incidencia de enfermedades
      • Derecho laboral, social, educativo y cultural
      • Derecho

      Contribuidores:

      Andrés CaicedoAndrés Caicedo