WHO informal consultation on development of guidelines on procedures and data requirements for changes to approved biotherapeutic products, Seoul, Republic of Korea, 27-28 April 2017.

Wadhwa, Meenu; Kang, Hye-Na; Hamel, Hugo; Jivapaisarnpong, Teeranart

Wadhwa, Meenu; Kang, Hye-Na; Hamel, Hugo; Jivapaisarnpong, Teeranart.

Afiliação

Wadhwa M; National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, Herts EN6 3QG, United Kingdom. Electronic address: Meenu.Wadhwa@nibsc.org.
Kang HN; Essential Medicines and Health Products (EMP) Department, World Health Organization (WHO), Avenue Appia 20, CH-1211, Geneva 27, Switzerland. Electronic address: kangh@who.int.
Hamel H; Monoclonal Antibodies Division, Biologics and Genetic Therapies Directorate, Health Canada, 100 Eglantine Driveway, A/L: 0602B, Tunney's Pasture, Ottawa, Ontario, K1A 0K9, Canada. Electronic address: Hugo.Hamel@hc-sc.gc.ca.
Jivapaisarnpong T; Department of Medical Sciences, Ministry of Public Health, Tivanon Road, Nonthaburi 11000, Thailand. Electronic address: teeranart.j@gmail.com.

Biologicals ; 52: 83-91, 2018 Mar.

Article em En | MEDLINE | ID: mdl-29289489

Assuntos

Terapia Biológica/normas; Guias de Prática Clínica como Assunto; Organização Mundial da Saúde; Congressos como Assunto; Humanos; República da Coreia

Palavras-chave

Biotherapeutic product; Post-approval changes; Regulation; World Health Organization

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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Organização Mundial da Saúde / Terapia Biológica / Guias de Prática Clínica como Assunto Tipo de estudo: Guideline Limite: Humans País/Região como assunto: Asia Idioma: En Revista: Biologicals Assunto da revista: ALERGIA E IMUNOLOGIA Ano de publicação: 2018 Tipo de documento: Article

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