890 resultados para ANVISA – Agência Nacional de Vigilância Sanitária


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O trabalho analisa a Indústria Petrolífera em três ambientes de atuação, mundial, nacional e estadual, a partir da observação de sete variáveis, a saber: caráter do petróleo; risco; economia de escala; integração; barreiras; tecnologia e ambiente. O estudo busca perceber as interações e os transbordamentos das variáveis selecionadas em cada um dos ambientes citados, em razão os aspectos econômicos e institucionais presentes nesta atividade, cujos resultados atingem diversos setores da economia e da sociedade como um todo e balizam o próprio processo de inovação da mesma. O estudo está alicerçado no arcabouço teórico neoschumpeteriano acerca dos aspectos voltados para concorrência e inovação, além da questão institucional, e se apóia em dados da Agência Nacional do Petróleo (A.N.P.), Ministério de Minas e Energia (MME), Movimento de Combate à Corrupção Eleitoral / Tribunal Superior Eleitoral (MCCE/TSE), Organization of the Petroleum Exporting Countries (OPEC), International Energy Agency (IAE), Institut Français Pétrole (IFP), United Nations Development Programme (UNDP). Avalia-se que em termos de caracterização da indústria petrolífera nos três ambientes considerados (mundial, nacional e local), há certa similitude no que se refere ao comportamento destas variáveis, com pequenas modificações suscitadas por fatores como grau de desenvolvimento e complexidade da atividade; resultado do ambiente concorrencial e inovativo; e, pelas influências institucionais acerca de atividades e grau de inserção das mesmas no ambiente socioeconômico onde estão localizadas a atividade produtiva e o seu entorno

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Pós-graduação em Pesquisa e Desenvolvimento (Biotecnologia Médica) - FMB

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Pós-graduação em Medicina Veterinária - FMVZ

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Apesar da política nacional de medicamentos propor que os mesmos tenham qualidade, efi cácia e segurança, os hospitais sentinelas têm recebido notifi cações de queixa técnica, reações adversas e suspeita de inefetividade terapêutica de medicamentos. Este estudo propôs identifi car os tipos de medicamentos notifi cados num hospital da Rede Sentinela, durante 18 meses, por suspeita de inefetividade terapêutica e verifi car a possibilidade de existência de polimorfos do fármaco, através de levantamento bibliográfi co. Foram identifi cadas 31 notifi cações de suspeita de inefetividade terapêutica de medicamentos similares, provenientes de onze fármacos diferentes, dos quais cinco podem apresentar polimorfos. No entanto, não signifi ca que os demais fármacos não apresentem polimorfos, sendo necessários estudos mais prolongados sobre o polimorfi smo, priorizando os estudos de fármacos com histórico de notifi cação de inefetividade terapêutica. Dados do presente estudo sugerem que testes de polimorfos sejam implantados na rotina do controle de qualidade da matéria-prima do fármaco, no desenvolvimento farmacotécnico do medicamento pela indústria farmacêutica e que o órgão sanitário federal exija os testes de polimorfi smo nos estudos de equivalência farmacêutica e estabilidade para o registro e pós-registro de medicamentos similares e genéricos, a fi m de assegurar a reprodutibilidade da qualidade, segurança e efi cácia comprovadas nos estudos in vivo de bioequivalência e biodisponibilidade relativa. Palavras-chave: polimorfi smo; vigilância sanitária; medicamento genérico; medicamento similar

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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

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This study aimed at apprehending and analyzing the perspective of Primary Health Care managers concerning nurses’ work in Children’s Health Surveillance in a city in São Paulo state. The study population consisted of eight professionals from different professional categories with direct activity in the city’s management of the population’s Health Surveillance. It is a descriptive, qualitative study. Data were collected by means of recorded semi-structured interviews. The framework used for data analysis was the thematic Content Analysis Method. The results were systematized into three themes: 1- Managers’ conceptualizations concerning Children’s Health Surveillance and its application in practice; 2- Managers’ perspectives concerning nurses’ work in Children’s Health Surveillance; 3- Qualification of Children’s Health Surveillance under the view of the municipal management. The conceptualizations concerning Children’s Health Surveillance that were apprehended showed to be convergent as they indicated this model’s appropriateness to identify and prioritize children’s care in vulnerability conditions in the territory where they live. However, some managers did not include, in their statements, health promotion aspects as one of the cornerstones of their managerial action. Nurses were considered to be fundamental in the Children’s Health Surveillance process due to their competencies and responsibilities undertaken in this health provision level. The main difficulties for adequate implementation of Children’s Health Surveillance in Primary Health Care and the proposal to overcome them were pointed out. It was concluded that, under the managers’ perspectives, nurses can greatly contribute to Children’s Health Surveillance in Primary Health Care as members of the health care team; however, to that end, they need professional qualification, structural conditions and institutional support with that regard

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The state of São Paulo is the largest producer of cane sugar in Brazil, with approximately 346 million tons in 2008/2009. This great production, associated with hot weather favors trade in sugar cane juice in most cities in the state. Contamination by parasites usually occurs during production but the contamination by bacteria is related with foodhandlers, equipment (grinders) and utensils used in the extraction. Due the lack of data in Botucatu and region, the objective of this study was to analyze 50 samples of syrup, according to the microbiological requirements of RDC Nº 12 (determination of Most Probable Number of thermotolerant coliform and the presence of Salmonella sp) as well the presence of Staphylococcus aureus and Trypanosoma cruzi. Salmonella sp., Staphylococcus aureus and Trypanosoma cruzi were not found, however 82% of the samples presented a higher contamination by thermotolerant coliform than that allowed by microbiological parameters, demonstrating inadequate conditions for retail, besides the lack of hygienic instructions of the sellers

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O uso de radiações ionizantes (R.I.), nas mais variadas atividades tem aumentado nas últimas décadas. Com o avanço tecnológico, novos e sofisticados equipamentos emissores de R.I. tem surgido no cenário nacional, o que torna imperativo a difusão do conhecimento sobre os conceitos de proteção radiológica junto à comunidade em geral, e neste sentido, o curso de física médica desenvolve um importante papel, quer seja no aspecto informativo quanto formativo de cidadãos e profissionais críticos e politicamente corretos, que possam contribuir com as Políticas Públicos dos órgãos normatizadores e fiscalizadores das atividades de vigilância sanitária. Conforme a legislação atual (Resolução SS-625 de 14/12/1994, da Secretaria de Estado da Saúde, e Portaria 453 de 01/06/1998 da Vigilância Sanitária do Ministério da Saúde), todos os serviços que utilizam radiações ionizantes devem realizar testes de avaliação dos parâmetros radiométricos dos equipamentos emissores de R.I., sendo exigidos as medidas de Levantamento Radiométrico das instalações, o Teste de Radiação de Fuga do cabeçote emissor e a implementação de Programa de Garantia de Qualidade dos equipamentos e dos procedimentos radiológicos. Este procedimento tem como objetivo principal a obtenção de imagens radiográficas com qualidade e a segurança de pacientes e profissionais, evitando a exposição desnecessária à radiação de pacientes e profissionais. A correta realização de procedimentos radiológicos além de reduzir a dose nos pacientes também promove significativa diminuição nos custos, por não haver necessidade da repetição dos exames. No Brasil, conforme dados da Secretaria de Atenção à Saúde SAS/MS, atualmente existem instalados 4.469 mamógrafos, 25.930 aparelhos de raios-x médicos, 39.438 aparelhos de raios-x odontológicos e...(Resumo completo, clicar acesso eletrônico abaixo)

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This qualitative study aimed at apprehending conceptualizations and at describing experiences of nurses working in the Family Health Strategy in a medium-sized city in São Paulo state in relation to Children’s Health Surveillance, with a special focus on nursing consultation. Data were collected from 12 nurses by means of recorded semi-structured interviews that were analyzed according to the Thematic Content Analysis Method. Results were systematized into four themes: Conceptualizations about Children’s Health Surveillance; Children’s Health Surveillance in the practice of the Family Health Strategy; Nursing consultation and Children’s Health Surveillance; Proposals to qualify Children’s Health Surveillance in the realm of the Family Health Strategy. It was possible to apprehend amplified and actual conceptualizations of Children’s Health Surveillance as well as to describe experiences surrounded by difficulties to incorporate the premises of this form of Children’s Health Care in the Family Health Strategy. Nursing consultation was noteworthy as a privileged moment, but not unique, to develop such practice. Finally, based on nurses’ proposals, the importance of triggering permanent education processes targeted at these themes in family-health services was considered

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Reservoirs are artificial ecosystems, intermediate between rivers and lakes, with diferent morphological and hydrological characteristics that can provide many important benefits to society. However, the use of this water for human consumption, watering livestock, leisure, irrigated agricultural production and pisciculture development, directly influence the increase loading of nutrients to aquatic environments and contribute to acceleration of eutrophication. Furthermore, global climate models are predicting a higher occurrence of extreme events such as floods and severe droughts, which will create hydrological stresses in lakes. In the semiarid northeast we can see the occurrence of these events, the drought of the years 2012, 2013 and 2014 was the worst drought in 60 years, according to the National Water Agency (ANA). Thus, this study aimed to evaluate the quality of the semiarid tropical water sources, identifying temporal patterns in periods with extreme hydrological events (floods and severe droughts). The study results showed that Gargalheiras and Cruzeta reservoirs presented significative changes in the limnological variables between rain and severe drought periods, with better appearance and in the most of the water quality variables in the rainy season and higher nutrientes concentrations and high electrical conductivity values in severe season, indicating decay of its quality. However, we found diferent behaviors between the reservoirs in severe drought. While Gargalheiras showed a typical behavior of the region, with high concentrations of algal biomass, indicating the worsening eutrophication, Cruzeta demonstrated a colapse in the total phytoplankton biomass, evidenced by the decrease in chla concentrations. This fact occurred because the low depth and proximity with the sediment facilited the inorganic solids resuspension and, consequently, resulted in turbid water column and light by limitation. In addition, the different behaviors between the reservoirs indicate that the responses of these environments problems such as extreme events must take into account factors such the region climate, size, depth of the reservoir and the basin characteristics.

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The Nursing Homes are an important alternative care in the world, but Brazil still has no valid instrument to monitor the quality these institutions. In the United States, the Observable Indicators of Nursing Home Care Quality Instrument (OIQ) is used to assess the quality of Nursing Home care using 30 indicators of structure (2 dimensions) and process (5 dimensions) related to quality person-centered care. The present study aimed at cross-culturally adapting the OIQ in order to evaluate the quality of Nursing Home care in Brazil. Conceptual and item equivalence were determined to assess the relevance and viability of OIQ in the Brazilian context, using the Content Validity Index (CVI) and a group of specialists composed of 10 participants directly involved in the object of study. Next, operational, idiomatic and semantic equivalence were carried out concurrently. This consisted of 5 phases: (1) two translations and (2) their respective back translations; (3) formal appraisal of referential and general meaning; (4) review by a second group of specialists; (5) application of the pretest at three Nursing Homes by different social entities: health professionals, sanitary surveillance regulators and potential consumers. Measurement equivalence was evaluated by the Cronbach’s alpha test to verify the internal consistency of the instrument. To measure inter-evaluator agreement, the General Agreement Index (ICG) and Kappa coefficient were used. Timely compliance and 95% Confidence Interval of indicators, dimensions and total construct were estimated. The CVI obtained high results for both relevance (95.3%) and viability (94.3%) in the Brazilian context. With respect to referential meaning, similarity was observed, ranging between 90-100% for the first back translation and 70-100% for the second. In relation to general meaning, version 1 was better, classified as “unchanged” in 80% of the items, whereas in version 2 it was only 47%. In the pretest, the OIQ was easy to understand and apply. The following outcomes were obtained: a high Cronbach’s alpha (0.93), satisfactory ICG (75%) and substantial agreement between the pairs of evaluators (health professionals, regulators from the Superintendency of Sanitary Surveillance SUVISA-, and potential consumers), according to the Kappa coefficient (0.65). It´s possible take the operational equivalence held since it preserved the original layout in the Brazilian version from the maintenance in application mode, response options, number of items, statements and scores. The performance of nursing homes obtained approximate average scores of 87, a variation 55-111 considering a range from 30 to 150 points. The worst outcomes were related to process indicators with a mean of 2.8 per item, while structure was 3.75 on a scale of 1 to 5. The lowest score was obtained for the care dimension (mean 2). The OIQ version was deemed to be a valid and reliable instrument in the Brazilian context. It is recommended that health professionals, regulators and potential consumers adopt it to access and monitor the quality of Nursing Home care and demonstrating opportunities for improvement.

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In Brazil, the National Agency of Electric Energy (ANEEL) represents the energy regulator. The rates review have been one of its main tasks, which establish a pricing practice at a level to cover the efficient operating costs and also the appropriate return of the distributors investments. The changes in the procedures to redefine the efficient costs and the several studies on the methodologies employed to regulate this segment denote the challenge faced by regulators about the best methodological strategy to be employed. In this context, this research aims to propose a benchmarking evaluation applied to the national regulation system in the establishment of efficient operating costs of electricity distribution utilities. The model is formulated to promote the electricity market development, partnering with government policies ant to society benefit. To conduct this research, an integration of Data Envelopment Analysis (DEA) with the Stochastic Frontier Analysis (SFA) is adopted in a three stages procedure to correct the efficiency in terms of environmental effects: (i) evaluation by means of DEA to measure operating costs slacks of the utilities, in which environmental variables are omitted; (ii) The slacks calculated in the first stage are regressed on a set of environmental variables by means of SFA and operating costs are adjusted to account the environmental impact and statistical noise effects; and, (iii) reassess the performance of the electric power distribution utilities by means of DEA. Based on this methodology it is possible to obtain a performance evaluation exclusively expressed in terms of management efficiency, in which the operating environment and statistical noise effects are controlled.