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WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June - 2 July 2021.
Wadhwa, Meenu; Kang, Hye-Na; Thorpe, Robin; Knezevic, Ivana; Aprea, P; Bielsky, M-C; Ekman, N; Heim, H-K; Joung, J; Kurki, P; Lacana, E; Njue, C; Nkansah, E; Savkina, M; Thorpe, R; Yamaguchi, T; Wadhwa, M; Wang, J; Weise, M; Wolff-Holz, E.
Afiliación
  • Wadhwa M; National Institute for Biological Standards and Control, Medicines and Healthcare Products Regulatory Agency, Potters Bar, United Kingdom.
  • Kang HN; World Health Organization, Department of Essential Medicines and Health Products, Avenue Appia 20, CH-1211, Geneva, Switzerland. Electronic address: kangh@who.int.
  • Thorpe R; Independent Expert, Welwyn, United Kingdom.
  • Knezevic I; World Health Organization, Department of Essential Medicines and Health Products, Avenue Appia 20, CH-1211, Geneva, Switzerland.
  • Aprea P; Administración Nacional de Medicamentos, Alimentos y Tecnología Medica, Argentina.
  • Bielsky MC; Medicines and Healthcare Products Regulatory Agency, United Kingdom.
  • Ekman N; Finnish Medicines Agency, Finland.
  • Heim HK; Federal Institute for Drugs and Medical Devices, Germany.
  • Joung J; Ministry of Food and Drug Safety, Republic of Korea.
  • Kurki P; University of Helsinki, Finland.
  • Lacana E; United States Food and Drug Administration, USA.
  • Njue C; Health Canada, Canada.
  • Nkansah E; Food and Drug Authority, Ghana.
  • Savkina M; Federal State Budgetary Institution Scientific Centre for Expert Evaluation of Medicinal Products, Russian Federation.
  • Thorpe R; Independent Expert, United Kingdom.
  • Yamaguchi T; Pharmaceuticals and Medical Devices Agency, Japan.
  • Wadhwa M; National Institute for Biological Standards and Control, Medicines and Healthcare Products Regulatory Agency, United Kingdom.
  • Wang J; Health Canada, Canada; National Institutes for Food and Drug Control, China.
  • Weise M; Federal Institute for Drugs and Medical Devices, Germany.
  • Wolff-Holz E; Paul-Ehrlich-Institut, Germany.
Biologicals ; 76: 1-9, 2022 Apr.
Article en En | MEDLINE | ID: mdl-35466023
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Contexto en salud: 11_ODS3_cobertura_universal / 2_ODS3 Problema de salud: 11_delivery_arrangements / 2_cobertura_universal Asunto principal: Biosimilares Farmacéuticos Tipo de estudio: Guideline Límite: Humans Idioma: En Revista: Biologicals Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2022 Tipo del documento: Article País de afiliación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Contexto en salud: 11_ODS3_cobertura_universal / 2_ODS3 Problema de salud: 11_delivery_arrangements / 2_cobertura_universal Asunto principal: Biosimilares Farmacéuticos Tipo de estudio: Guideline Límite: Humans Idioma: En Revista: Biologicals Asunto de la revista: ALERGIA E IMUNOLOGIA Año: 2022 Tipo del documento: Article País de afiliación: Reino Unido