Regulamentação Sanitária de Medicamentos

A regulamentação sanitária de medicamentos é uma das oito diretrizes da Política Nacional de Medicamentos. Trata-se da fiscalização e regulamentação de registro de medicamentos e da autorização de funcionamento desde os produtores até o varejo de medicamentos, bem como das restrições àqueles sujeitos a controle especial. A regulamentação sanitária de medicamentos tem como objetivo garantir eficácia, segurança, qualidade e custo aos produtos farmacêuticos. Os estudos clínicos dos medicamentos de Referência, a bioequivalência ou biodisponibilidade relativa e testes de equivalência dos medicamentos similares e genéricos são meios de avaliar a eficácia e a segurança. A qualidade é garantida lote a lote pelas Boas Práticas de Fabricação e Controle dos produtos farmacêuticos e a certificação da empresa pela ANVISA. O custo é avaliado pela câmara técnica de medicamento (CMED), que estabelece os critérios para fixação e ajuste de preços dos produtos farmacêuticos. No pós-registro, a efetividade, segurança e qualidade dos produtos são avaliadas por meio das comprovações exigidas na renovação do registro e, principalmente, pelo programa de farmacovigilância. Palavras-chave: Registro de Produtos. Medicamentos de Referência. Medicamentos Similares. Medicamentos Genéricos. Alteração de Registro de Produtos. ABSTRACT Health Regulations for Drugs The health regulation of drugs is one of eight guidelines issued within the National Drug Policy. It refers to the supervision and regulation of drug registration and the approval of operations, from the manufacturers to the retailers of medicines, as well as the restrictions that apply to drugs under special control. The health regulation of medicines is aimed at controlling the effectiveness, safety, quality and cost of pharmaceutical products. Clinical studies of brand-name (innovator) medicines, bioequivalence or relative bioavailability and the equivalence tests of generic and ‘similar’ brand-name drugs are means used to assess efficacy and safety. Quality is assured on a batch-to-batch basis by compliance with the Good Manufacturing Practices and Control of pharmaceutical products and by the certification of companies offered by ANVISA. The cost of a medicine is assessed by the Technical Chamber of Medicine (CMED), which establishes the criteria for setting and adjusting the prices of pharmaceutical products. After registration, the effectiveness, safety and quality of products are monitored by means of the tests required on renewal of registration and especially by the pharmacovigilance program. Keywords: Product Registration. Original Brand-name Drugs. Similar Drugs. Generic Drugs. Modification of Product Registration.

Estudo do Comportamento da Viscosidade de Sistemas de Carboximetilcelulose de Sódio e Diferentes Componentes nos produtos para industria alimentícia

Currently, the food market is a great competition. It is no longer unanimously in the CMC powder drinks, as in the past, xanthan gum, always seeking to develop more economic alternatives, such as guar gum. It is clear, therefore, it is of vital importance to understand thoroughly the operation of a particular product in different process conditions and with different materials so that we can develop and adapt both new processes and products to new market reality

Regulamentação e etapas da certificação de produtos orgânicos no Brasil

A busca por alimentos chamados popularmente de orgânicos, produzidos sem o uso de agrotóxicos, fertilizantes, insumos químicos ou organismos geneticamente modificados, vem se consolidando mundialmente. O crescimento do mercado mundial de produtos orgânicos criou uma demanda pela normatização, regulamentação e certificação da produção orgânica em diversos países. Por pressão de países importadores, houve a necessidade de que produtos orgânicos brasileiros fossem certificados através de normas e padrões de qualidade reconhecidos internacionalmente. Este trabalho tem como objetivo descrever a legislação brasileira referente à certificação de produtos orgânicos. Foram descritos os conteúdos das leis e normas que compõem o arcabouço legal referente ao tema. A regulamentação da agricultura orgânica no Brasil teve início com publicação da Lei 10.831/2003 e sua regulamentação pelo Decreto 6.323/2007, que estabeleceu a obrigatoriedade da certificação de produtos orgânicos por organismo de certificação reconhecido oficialmente. Todos aqueles que produzem, transportam, comercializam ou armazenam produtos orgânicos (exceto aqueles pertencentes à agricultura familiar) ficaram obrigados a regularizar suas atividades e estarem inseridos no Cadastro Nacional de Produtores Orgânicos

Redução do tempo de setup de máquinas de usinagem em uma industria automobilística

Continuous improvement of industrial processes is one way to become companies more competitive in the market. For this, a fairly widespread use is the methodology of lean production systems, by eliminating waste. One of the tools of these systems is the method of rapid exchange of die or also called SMED, which will be applied in this study. The study aims to develop proposals for reducing the time of set up of two machines in two machining lines, watching also the ergonomics and safety conditions in this operations. The set up time reduction is justified among others, due to increase the machine productivity. In applying the connecting rod machining line, there were two types of exchange. Reductions in time to set up proposals reached values of 47% to one of them, and 55% to the other. It is important to underline that to reach this result, there was no need for large investments. In the application in block machining line, was developed an improvement in the ergonomic area. It was placed a pulley block that came to increase the time of tool change. Aiming to improve the security of the exchange, without productivity loss, the method was applied to reduce this time. It was developed two proposals.: the first would reduce that time by 19%, and does not require many resources of the company. The second involves the parallelization of the exchange, so that the reduction is 48%. However, this proposal requires one more manpower at the time of exchange and it is not always possible

Absentismo laboral por patología odontológica y médica en una industria de gran porte del sector mecánico y mueblero

Introduction: The current Brazilian legislation states that health services must be performed by the Specialized Service of Safety Engineering and Labor Medicine (SESMT). Objective: To analyze the dental and medical reasons for absenteeism, checking the interference of factors such as age, gender and position of the worker, and most of the reasons that led the employee to miss work. Material and methods: The research appears as a descriptive study with a quantitative approach. The dental and medical certificates and statements of attendance were analyzed, duly approved, lodged in a acrylic industry in the city of Araçatuba-SP, from January to July 2011. Results: Of the total number of certificates (n = 1841), only 103 (5.6%) were for dental reasons. Predominance of the age group of 20-29 years, males and with non-administrative function. The reasons most dental and medical certificates stated that led the workers to miss working days were "inclusive and impacted teeth" and "diarrhea and gastroenteritis of presumed infectious origin", respectively. As to factors related to absenteeism, there was a severity index of 2.83, 1.33 frequency and average duration of absences of 2.12. Conclusions: It is concluded that dental reasons had little weight on total absences due to illness that caused the temporary leave of the worker for a shorter period. The age and function variables influence the occurrence of work absenteeism.

Propriedade intelectual e as indústrias criativas: cultura digital, regulamentação e as licenças públicas

When we think of a transposition from a traditional culture industry to the new coherence of the creative industries, a number of new parallel discussions arises, encircled by the reconfiguration of the value chain of such industries and, not only, but also due to a change on creation coherence of a product whose most valuable input is creativity. Therefore, as a mechanism through which such creativity is valued, the intellectual property becomes one of the key elements of this debate, mainly in a world where the coherence of distribution transcends the physical copies towards the digitization of content. From this initial debate, the present article seeks to weave the main relations between the theme of creative industries and the intellectual property, describing the adversities of a deficient regulation and its consequences on the creative industries production, indicating the existing alternatives and questioning the balance between two forces: the collective and the individual rights.

O direito de pertencer a si mesmo: a despatologização do transexualismo e sua regulamentação jurídica como direito fundamental ao gênero

Pós-graduação em Direito - FCHS

O clima em sua regulamentação político-econômica: o acordo de Copenhague - COP 15

We know that the Earth goes through natural cycles that influence its climate and the development of their societies. In recent decades, climate changes and nature began to call world attention to the unbridled exploitation that was carried by the current economic system, causing unrest among scientific, social, political and economic world. The theory that man causes a warming in global temperatures by the release of greenhouse gases made the headlines of major newspapers in the world. From there, it was only a matter of time before environmental concerns became ownership of capital by its excessive appropriation. The fear of nuclear threat by the bombs of Hiroshima and Nagasaki left in fanfare the world, which together with the devastating impact of the exploitation of man and nature gave birth to the Environmental Revolution, a way of trying to change the development patterns of the time and behavior of the population. However, based on the historical form of capitalist domination, this was another measure that was apossada the economic system being transformed into economic value and political exchange. The origin of the conventions, meetings, conferences, parliaments set up to discuss environmental issues, eventually became forums of political and economic talks focused on environmental governance, valuing an asset that is public and everyone. Environmental and climate issue now has a value, thus turning the agenda on the agenda of the United Nations (UN) for its political and economic regulation in the form of global agreement. Given the need for understanding the climate issue, was born the Conference of the Parties (COPs), a regulatory body for climate negotiations, surrounded interests, complexities, conflicts and disagreements between the parties countries, which becomes clear when we analyze their agreements...

O clima em sua regulamentação político-econômica: o acordo de Copenhague - COP 15

We know that the Earth goes through natural cycles that influence its climate and the development of their societies. In recent decades, climate changes and nature began to call world attention to the unbridled exploitation that was carried by the current economic system, causing unrest among scientific, social, political and economic world. The theory that man causes a warming in global temperatures by the release of greenhouse gases made the headlines of major newspapers in the world. From there, it was only a matter of time before environmental concerns became ownership of capital by its excessive appropriation. The fear of nuclear threat by the bombs of Hiroshima and Nagasaki left in fanfare the world, which together with the devastating impact of the exploitation of man and nature gave birth to the Environmental Revolution, a way of trying to change the development patterns of the time and behavior of the population. However, based on the historical form of capitalist domination, this was another measure that was apossada the economic system being transformed into economic value and political exchange. The origin of the conventions, meetings, conferences, parliaments set up to discuss environmental issues, eventually became forums of political and economic talks focused on environmental governance, valuing an asset that is public and everyone. Environmental and climate issue now has a value, thus turning the agenda on the agenda of the United Nations (UN) for its political and economic regulation in the form of global agreement. Given the need for understanding the climate issue, was born the Conference of the Parties (COPs), a regulatory body for climate negotiations, surrounded interests, complexities, conflicts and disagreements between the parties countries, which becomes clear when we analyze their agreements...

Revista Crás!: quadrinhos brasileiros e industria editorial

Este artigo tem como objetivo resgatar a trajetória das histórias em quadrinhos brasileiras na década de 1970, considerada de especial relevância para o avanço da arte gráfica sequencial no Brasil. Nesse período, observa-se, de um lado, iniciativas de pequenas editoras localizadas em vários estados brasileiros, e, de outro, empreendimentos feitos por editoras de grande porte na publicação de material nacional. Como estudo de caso, apresenta a revista Crás!, produzida pela Editora Abril, de São Paulo, que reuniu talentos veteranos e jovens da arte gráfica sequencial brasileira. A análise dessa publicação revela as dificuldades do quadrinho brasileiro frente às necessidades e limites das editoras comerciais e do mercado editorial no país.

Problemas de estimação de custo de capital de empresas concessionárias no Brasil: uma aplicação à regulamentação de concessões rodoviárias

Neste trabalho, discute-se a fixação de taxas de retorno de concessões no Brasil, com aplicação específica ao caso da metodologia da Agência Nacional de Transportes Terrestres (ANTT). Mostra-se a inadequação da regulamentação vigente, baseada no conceito de taxa interna de retorno (TIR), e não de custo de oportunidade do capital. A partir de um exemplo com dados referentes ao auge da crise financeira internacional (dezembro de 2008), evidencia-se também a falta de lógica decorrente da utilização de retornos e preços passados na estimação de taxas de retorno, um procedimento comum a toda a área de concessões de serviços públicos no Brasil. Propõe-se uma metodologia alternativa cujos resultados são sensíveis às condições correntes de mercado de capitais, que produz resultados coerentes com a situação então vigente.