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Marketing Regulatory Oversight of Advanced Therapy Medicinal Products in Europe.
Schuessler-Lenz, Martina; Herberts, Carla; Reischl, Ilona; Ruiz, Sol; Celis, Patrick; Beuneu, Claire; Kjeken, Rune; Timón, Marcos.
Afiliação
  • Schuessler-Lenz M; Division Haematology/Cell and Gene Therapies, Paul-Ehrlich-Institute, Federal Institute for Vaccines and Biomedicines, Langen, Germany.
  • Herberts C; Division Europe, Medicines Evaluation Board, RG, Utrecht, Netherlands.
  • Reischl I; Division Clinical Trials, Institute Surveillance, Austrian Medicines and Medical Devices Agency (AGES MEA), Vienna, Austria.
  • Ruiz S; Division Biological Products, Advanced Therapies and Biotechnology, Spanish Medicines Agency, Madrid, Spain.
  • Celis P; Advanced Therapies Office, European Medicines Agency, Amsterdam, Netherlands.
  • Beuneu C; Federal Agency for Medicines and Health Products, Brussels, Belgium.
  • Kjeken R; Norwegian Medicines Agency, Oslo, Norway.
  • Timón M; Division Biological Products, Advanced Therapies and Biotechnology, Spanish Medicines Agency, Madrid, Spain. mtimon@aemps.es.
Adv Exp Med Biol ; 1430: 1-21, 2023.
Article em En | MEDLINE | ID: mdl-37526839

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

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