Banca de QUALIFICAÇÃO: Kelly Lucy Guimarães Gomes

Uma banca de QUALIFICAÇÃO de DOUTORADO foi cadastrada pelo programa.
STUDENT : Kelly Lucy Guimarães Gomes
DATE: 31/08/2022
TIME: 14:00
LOCAL: Plataforma Microsoft Teams
TITLE:

Produtos de terapias avançadas: regulação e monitoramento sanitário no Brasil, Estados Unidos da América, Europa e Japão.

KEY WORDS:

gene therapy, advanced cell therapy, tissue engineering, regulatory framework

PAGES: 100
BIG AREA: Ciências da Saúde
AREA: Saúde Coletiva
SUMMARY:

Advanced therapy medicinal products (ATMPs) are a class of biological products for human use that are based on genes, cells and tissues. The first ATMP received marketing authorization in Europe in 2009, whereas Brazil granted the first authorization in 2020. The objective of this study was to compare the regulatory models adopted by Brazil, the USA, Japan and the European Union, which comprise the member countries of the Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use for ATMP

BANKING MEMBERS:
Interna - 404501 - DIRCE BELLEZI GUILHEM
Externo ao Programa - 1681340 - EVERTON NUNES DA SILVA
Presidente - 087.616.438-66 - MARIA RITA CARVALHO GARBI NOVAES - UnB
Externa ao Programa - 1554093 - MARIE TOGASHI