Regulatory Processes and Standards Required for Marketing Authorization of Vaccines in Brazil

Detalhes bibliográficos
Autor(a) principal: Matsuoka, Sheila Barros
Data de Publicação: 2019
Outros Autores: Castanheira, Laura Gomes, Silveira, Ivna Alana da
Tipo de documento: Artigo de conferência
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/32783
Resumo: Os autores externos submeteram sua publicação para apresentação de trabalho no evento “International Symposium on Immunobiologicals”, que foi coordenado e organizado pelo Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos), da Fundação Oswaldo Cruz.
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spelling Matsuoka, Sheila BarrosCastanheira, Laura GomesSilveira, Ivna Alana da2019-04-26T15:05:29Z2019-04-26T15:05:29Z2019MATSUOKA, S. B.; CASTANHEIRA, L. G.; SILVEIRA, I. A. da. Regulatory Processes and Standards Required for Marketing Authorization of Vaccines in Brazil. In: INTERNATIONAL SYMPOSIUM ON IMMUNOBIOLOGICAL, 4., 2019; SEMINÁRIO ANUAL CIENTÍFICO E TECNOLÓGICO DE BIO-MANGUINHOS, 7., 2019, Rio de Janeiro. Anais... Rio de Janeiro: Bio-Manguinhos, 2019. p. 142.https://www.arca.fiocruz.br/handle/icict/3278310.35259/isi.sact.2019_32783Os autores externos submeteram sua publicação para apresentação de trabalho no evento “International Symposium on Immunobiologicals”, que foi coordenado e organizado pelo Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos), da Fundação Oswaldo Cruz.Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.Sem afiliação.Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.engFiocruz/Instituto de Tecnologia em ImunobiológicosVacinasRequisitos regulamentaresAutorização de marketingVaccinesRegulatory requirementsMarketing AuthorizationVacinasRegulatory Processes and Standards Required for Marketing Authorization of Vaccines in Brazilinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/conferenceObjectinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txttext/plain1748https://www.arca.fiocruz.br/bitstream/icict/32783/1/license.txt8a4605be74aa9ea9d79846c1fba20a33MD51ORIGINALMAN_09.pdfapplication/pdf48417https://www.arca.fiocruz.br/bitstream/icict/32783/2/MAN_09.pdf4723a465afbd8bc3c0697c605f4c1e2aMD52TEXTMAN_09.pdf.txtMAN_09.pdf.txtExtracted texttext/plain3325https://www.arca.fiocruz.br/bitstream/icict/32783/3/MAN_09.pdf.txt46dbb1a032da959e7decacec973aa6c6MD53icict/327832023-04-26 16:59:43.506oai:www.arca.fiocruz.br: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Repositório InstitucionalPUBhttps://www.arca.fiocruz.br/oai/requestrepositorio.arca@fiocruz.bropendoar:21352023-04-26T19:59:43Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.pt_BR.fl_str_mv Regulatory Processes and Standards Required for Marketing Authorization of Vaccines in Brazil
title Regulatory Processes and Standards Required for Marketing Authorization of Vaccines in Brazil
spellingShingle Regulatory Processes and Standards Required for Marketing Authorization of Vaccines in Brazil
Matsuoka, Sheila Barros
Vacinas
Requisitos regulamentares
Autorização de marketing
Vaccines
Regulatory requirements
Marketing Authorization
Vacinas
title_short Regulatory Processes and Standards Required for Marketing Authorization of Vaccines in Brazil
title_full Regulatory Processes and Standards Required for Marketing Authorization of Vaccines in Brazil
title_fullStr Regulatory Processes and Standards Required for Marketing Authorization of Vaccines in Brazil
title_full_unstemmed Regulatory Processes and Standards Required for Marketing Authorization of Vaccines in Brazil
title_sort Regulatory Processes and Standards Required for Marketing Authorization of Vaccines in Brazil
author Matsuoka, Sheila Barros
author_facet Matsuoka, Sheila Barros
Castanheira, Laura Gomes
Silveira, Ivna Alana da
author_role author
author2 Castanheira, Laura Gomes
Silveira, Ivna Alana da
author2_role author
author
dc.contributor.author.fl_str_mv Matsuoka, Sheila Barros
Castanheira, Laura Gomes
Silveira, Ivna Alana da
dc.subject.other.pt_BR.fl_str_mv Vacinas
Requisitos regulamentares
Autorização de marketing
topic Vacinas
Requisitos regulamentares
Autorização de marketing
Vaccines
Regulatory requirements
Marketing Authorization
Vacinas
dc.subject.en.pt_BR.fl_str_mv Vaccines
Regulatory requirements
Marketing Authorization
dc.subject.decs.none.fl_str_mv Vacinas
description Os autores externos submeteram sua publicação para apresentação de trabalho no evento “International Symposium on Immunobiologicals”, que foi coordenado e organizado pelo Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos), da Fundação Oswaldo Cruz.
publishDate 2019
dc.date.accessioned.fl_str_mv 2019-04-26T15:05:29Z
dc.date.available.fl_str_mv 2019-04-26T15:05:29Z
dc.date.issued.fl_str_mv 2019
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/conferenceObject
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status_str publishedVersion
dc.identifier.citation.fl_str_mv MATSUOKA, S. B.; CASTANHEIRA, L. G.; SILVEIRA, I. A. da. Regulatory Processes and Standards Required for Marketing Authorization of Vaccines in Brazil. In: INTERNATIONAL SYMPOSIUM ON IMMUNOBIOLOGICAL, 4., 2019; SEMINÁRIO ANUAL CIENTÍFICO E TECNOLÓGICO DE BIO-MANGUINHOS, 7., 2019, Rio de Janeiro. Anais... Rio de Janeiro: Bio-Manguinhos, 2019. p. 142.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/32783
dc.identifier.doi.none.fl_str_mv 10.35259/isi.sact.2019_32783
identifier_str_mv MATSUOKA, S. B.; CASTANHEIRA, L. G.; SILVEIRA, I. A. da. Regulatory Processes and Standards Required for Marketing Authorization of Vaccines in Brazil. In: INTERNATIONAL SYMPOSIUM ON IMMUNOBIOLOGICAL, 4., 2019; SEMINÁRIO ANUAL CIENTÍFICO E TECNOLÓGICO DE BIO-MANGUINHOS, 7., 2019, Rio de Janeiro. Anais... Rio de Janeiro: Bio-Manguinhos, 2019. p. 142.
10.35259/isi.sact.2019_32783
url https://www.arca.fiocruz.br/handle/icict/32783
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Fiocruz/Instituto de Tecnologia em Imunobiológicos
publisher.none.fl_str_mv Fiocruz/Instituto de Tecnologia em Imunobiológicos
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
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