3 resultados para Regulatory Administrative Law

em Repositório Institucional UNESP - Universidade Estadual Paulista "Julio de Mesquita Filho"


Relevância:

80.00% 80.00%

Publicador:

Resumo:

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Relevância:

80.00% 80.00%

Publicador:

Resumo:

Radiography is currently an important method of diagnosis, both medical, dental and veterinary. The image in this type of survey is obtained using an X-ray beam, where the radiologist can possibly view structures of interest. It isn't always possible to get the desired images due to various factors, such as equipment limitations. The Administrative Law 453/98, the State Resolution SS 625/94, and other standards require testing and quality control acceptance limits that guarantee a good performance of the equipment for the security and quality of care, giving service users greater effectiveness in exams. This study were performed in the accompaniment of testing procedures for quality control established by Administrative Law 453/98 in several X-ray equipment to make a comparison and optimization in the descriptions of the procedures used by the Institute for Electrical Energy and the University of São Paulo (IEE / USP / SP).The optimization of the procedures were performed with the aid of a current literature, the Resolution 453/98, State Resolution SS 625/94 and other international standards. On this basis it was possible to observe the importance of regular monitoring of tests for an update, following the technological development of instruments used in the service

Relevância:

30.00% 30.00%

Publicador:

Resumo:

Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use andduring clinical trials. Legal requirements for pharmacovigilance in some Latin American countries (Argentina, Brazil, Chile, Paraguay and Uruguay) were reviewed. Disparities in the legal framework among the countries are observed being those for marketing authorization holders one of the most evident. Theactive rol of the universities and drug information centers for/of pharmacovilance seems to be a positivecommon point. Legal requirements regarding pharmacovigilance of biosimilar medicines, is still a pointto be developed.