The Regulation of Cell Therapy and Gene Therapy Products in Switzerland.

Bukovac, Petra Kempná; Hauser, Michel; Lottaz, Daniel; Marti, Andreas; Schmitt, Iris; Schochat, Thomas

Bukovac, Petra Kempná; Hauser, Michel; Lottaz, Daniel; Marti, Andreas; Schmitt, Iris; Schochat, Thomas.

Afiliação

Bukovac PK; Swissmedic, Swiss Agency for Therapeutic Products, Berne, Switzerland.
Hauser M; Swissmedic, Swiss Agency for Therapeutic Products, Berne, Switzerland.
Lottaz D; Swissmedic, Swiss Agency for Therapeutic Products, Berne, Switzerland.
Marti A; Swissmedic, Swiss Agency for Therapeutic Products, Berne, Switzerland. andreas.marti@swissmedic.ch.
Schmitt I; Swissmedic, Swiss Agency for Therapeutic Products, Berne, Switzerland.
Schochat T; Swissmedic, Swiss Agency for Therapeutic Products, Berne, Switzerland.

Adv Exp Med Biol ; 1430: 41-58, 2023.

Article em En | MEDLINE | ID: mdl-37526841

Assuntos

Terapia Baseada em Transplante de Células e Tecidos; Marketing; Humanos; Suíça; Terapia Genética/efeitos adversos

Palavras-chave

ATMP; Cell therapy; Clinical considerations; Clinical trial; GMO; Gene therapy; Marketing authorization; Nonclinical considerations; Quality considerations; Regulatory Authority; Scientific advice; Swissmedic; Switzerland; Tissue engineering products; Transplant product

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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Marketing / Terapia Baseada em Transplante de Células e Tecidos Tipo de estudo: Guideline / Health_technology_assessment Limite: Humans País como assunto: Europa Idioma: En Ano de publicação: 2023 Tipo de documento: Article

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