Regulatory Issues In Brazil
Mostrando 1-12 de 28 artigos, teses e dissertações.
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1. The tale of lenalidomide clinical superiority over thalidomide and regulatory and cost-effectiveness issues
Resumo A Agência Nacional de Vigilância Sanitária (ANVISA) aprovou em abril de 2017 a lenalidomida (LEN) para o mieloma múltiplo (MM) e síndrome mielodisplásica. A ANVISA havia negado o registro em 2010, e indeferido um recurso apresentado em 2012. O motivo do indeferimento foi a falta de estudos comparativos de efetividade demonstrando que LEN era mai
Ciênc. saúde coletiva. Publicado em: 26/09/2019
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2. Factors associated with the structural liquidity of banks in Brazil
RESUMO O trabalho teve por fim identificar a relação do índice de liquidez estrutural (ILE) com variáveis macroeconômicas, características dos bancos e vigência do Acordo de Basileia III. Embora a discussão acadêmica sobre liquidez bancária aborde essencialmente questões de curto prazo, o monitoramento da liquidez de longo prazo permite avaliar a
Rev. contab. finanç.. Publicado em: 18/02/2019
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3. Animal models in biological and biomedical research - experimental and ethical concerns
ABSTRACT Animal models have been used in experimental research to increase human knowledge and contribute to finding solutions to biological and biomedical questions. However, increased concern for the welfare of the animals used, and a growing awareness of the concept of animal rights, has brought a greater focus on the related ethical issues. In this revie
An. Acad. Bras. Ciênc.. Publicado em: 04/09/2017
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4. SMART MONITORING AND DECISION MAKING FOR REGULATING ANNULUS BOTTOM HOLE PRESSURE WHILE DRILLING OIL WELLS
Abstract Real time measurements and development of sensor technology are research issues associated with robustness and safety during oil well drilling operations, making feasible the diagnosis of problems and the development of a regulatory strategy. The major objective of this paper is to use an experimental plant and also field data, collected from a basi
Braz. J. Chem. Eng.. Publicado em: 2016-12
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5. Historical review of clinical vaccine studies at Oswaldo Cruz Institute and Oswaldo Cruz Foundation - technological development issues
This paper presents, from the perspective of technological development and production, the results of an investigation examining 61 clinical studies with vaccines conducted in Brazil between 1938-2013, with the participation of the Oswaldo Cruz Institute (IOC) and the Oswaldo Cruz Foundation (Fiocruz). These studies have been identified and reviewed accordin
Mem. Inst. Oswaldo Cruz. Publicado em: 16/01/2015
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6. Cancer research in Brazil - stuck in second gear?
This article describes the main issues regarding clinical cancer research in Brazil, including both the opportunities and the hurdles. Scientists and clinicians in this field had the opportunity to talk to regulatory agencies and to the Health Ministry representative at a meeting held in the State of Rio de Janeiro, Brazil, in April 2014. Our conclusions are
Braz J Med Biol Res. Publicado em: 13/01/2015
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7. Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil
Radiofármacos são compostos que possuem um radionucleotídeo, podendo ser emissor de radiação gama (γ) ou emissor de pósitrons (β+), ligado a uma molécula específica com finalidade diagnóstica e terapêutica. O avanço no uso dos radiofármacos tem culminado a um setor em comum com outros tipos de medicamentos: a regulamentação e fiscalização.
Braz. J. Pharm. Sci.. Publicado em: 2014-04
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8. Os caminhos do Programa Economia Solidária em desenvolvimento / The ways of the Solidarity Economy Development Program
This research was guided by the realization that the path of scientific research on the topic solidary economy in Brazil was based mainly on the urban initiatives of work organization. The crisis in the world of work that affected the country from the 1970s was the privileged locus for the problematization of the solidarity economy in Brazil. In addition, th
IBICT - Instituto Brasileiro de Informação em Ciência e Tecnologia. Publicado em: 01/07/2011
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9. Um estudo dos processos de regulação e governança socioambiental do setor sucroalcooleiro no Brasil
In the last five years, there was an increase the ethanol production in Brazil, thanks to the ex-pansion of this sector in the Brazilian Cerrado. Despite all the scientific and technological development for sustainable production of ethanol, the environmental, social and labor also affect the credibility of the product, both domestically and externally. Alon
IBICT - Instituto Brasileiro de Informação em Ciência e Tecnologia. Publicado em: 06/06/2011
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10. Essays on regulatory risk issues
Most studies around that try to verify the existence of regulatory risk look mainly at developed countries. Looking at regulatory risk in emerging market regulated sectors is no less important to improving and increasing investment in those markets. This thesis comprises three papers comprising regulatory risk issues. In the first Paper I check whether CAPM
Publicado em: 06/07/2010
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11. THE FISCAL REGIME IMPACT ON SUBSALT RESERVES DEVELOPMENT / O IMPACTO DO MARCO REGULATÓRIO SOBRE O DESENVOLVIMENTO DAS RESERVAS DO PRÉ-SAL
The adoption of tax systems in different industries has been a discussion subject in academic circles for several years. Although a conclusion hasn¿t been reached yet about which system is more efficient, there is a consensus that tax systems should be neutral. In other words, the level of investment and the economic activity shouldn¿t be affected by its a
Publicado em: 2010
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12. Gestão de segurança da informação - uma proposta para potencializar a efetividade da segurança da informação em ambiente de pesquisa científica / Information security management a proposal to improve the effectiveness of information security in the scientific research environment
The increase of the connectivity in the business environment, combined with the growing dependency of information systems, has become the information security management an important governance tool. Information security has as main goal to protect the business transactions in order to work normally. In this way, It will be safeguarding the business continui
IBICT - Instituto Brasileiro de Informação em Ciência e Tecnologia. Publicado em: 30/11/2009