EXTRATO PRÉVIO Nº 6071/2018
| Data de publicação | 30 Julho 2018 |
| Páginas | 8-8 |
| Órgão | Ministério da Ciência, Tecnologia, Inovações e Comunicações,Comissão Técnica Nacional de Biossegurança |
| Seção | DO3 |
EXTRATO PRÉVIO Nº 6071/2018
A Presidente da Comissão Técnica Nacional de Biossegurança - CTNBio, no uso de suas atribuições e de acordo com o artigo 14, inciso XIX, da Lei 11.105/05 e do Art. 5, inciso XIX do Decreto 5.591/05, torna público que encontra-se em análise na Comissão o processo a seguir discriminado:
Processo nº 01250.027567/2018-81
Requerente: GlaxoSmithKiine Brasil ltda.
CNPJ: 27.067.651/0001-55
Endereço: Estrada dos Bandeirantes, 8464 - Rio de Janeiro - RJ. CEP: 22783-110.
Assunto: Solicitação de parecer para estudo clínico com com organismos geneticamente modificados da classe de risco 1.
Ementa: A Sra. Maria Del Pilar Rubio-Mejia, responsável legal da GlaxoSmithKline Brasil Ltda., solicita à CTNBio parecer técnico para execução de estudo clinico com organismos geneticamente modificados da classe de risco 1. Os organismos a serem manipulados nas instalações são: Vacina experimental contra o vírus sincicial respiratório (RSV) da GSK Biologicals baseada em proteínas virais F, N e M2-1 do RSV codificadas pelo adenovetor derivado de chimpanzé (ChAd155-RSV) da Classe de risco I . As instalações a serem utilizadas no estudo clínico são denominadas: Unidade Operativa 1: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da USP, situada no endereço: Bloco...
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