Novas fronteiras petrolíferas no Brasil : uma análise da necessidade de nova regulamentação da área do pré-sal sob a ótica constitucional

The Oil industry in Brazil has gone through several stages during the economical, political and social historical process. However, the significative changes have happened in the last fifteen years, due to market opening arising from the relaxation of the state monopoly over the Oil deposits and its derivatives. The edition of the Constitutional Amendment #9, changing the first paragraph of the 177th item of the Federal Constitution, marked the end of a stiffness about the monopoly that the Brazilian state kept in relation to the exploration and research of Oil and Gas. The economical order was fundamental to actualize the idea contained in the #9 Amendment, since its contents has the power to set up measures to be adopted by public power in order to organize the economical relations from a social viewpoint. The new brazilian Oil scenery, called pre-salt, presents itself in a way to amaze the economical markets, in addition to creating a new perspective to the social sector. This work will identify, in this new scenario, the need for change in the legal system. Nevertheless, this subject must not be treated in a thoughtless way: being an exhaustible good, we shall not forget that the future generations also must benefit from the exploration of natural resources recently discovered. The settlement of a new regulatory mark, including the change in the concession contract model to production and sharing is one of the suggested solutions as a bill in the National Congress, in an attempt to ensure the sovereignty of the nation. The constitutionality of a new regulatory mark is questioned, starting from an analysis of the state monopoly, grounding the comprehnsions in the brazilian constitutions, the relevance of the creation of Petrobras for self-assertion of the state about the monopoly of Oil and derivatives, and its posture after the Constitutional Amendment nº 9 (1995), when a company stops having control of the state monopoly, beginning to compete in a fairly way with other companies. The market opening and private initiative are emphasized from the viewpoint of the Constitutional Principles of the Economical and Social Order. The relaxation of the monopoly regarding the exploratory activity in the Federal Constitution doesn't deprive from the Union the ownerships of underground goods, enabling to this federal entity to contract, directly or by concession of exploration of goods, to state-owned or private companies. The existing oil in the pre-salt layer transforms the scenario from very high risk to low risk, which gives the Union the possibility of defining another way of exploring this resources in the best interests of the Public Administration

Competição e regulamentação no transporte de passageiros: Um estúdio no transporte rodoviário intermunicipal

The objective of this research is the verification of the competition in the intecity market, after the entrance of new competitors (vans and microbus) regulated and clandestine. For verification of this new view was effected one research of documentary character for the knowledge of the regulation and exploratory character of the system Natal - territory of the Seridó, for thus in making will know this problematic, well as its characteristics, attractivenesses and development of the territory of the Seridó, and its link with the Capital (Natal). Later, through a descriptive exploratory research of the type survey with the passengers to know as these are being taken care and its satisfaction in relation to the regulated companies. With the drivers if focus effected one group, and with the staff of the of sale ticket a research survey, aiming at to know the strategies used for the only company of bus that takes care of the territory of the Seridó, the implantation of these and the consequence of the user. In accordance with the generic tipologia of Porter and its strategies, were perceived that the bus company adopted the strategy of price leadership being competitive, using to advantage its bigger space in the market, already vans and the microbuses with its limited participation bet in a strategy of "differentiation" in its service, effecting faster trips and in the strategy of "approach" we find the not regulated services earn the service to the taste of the user

Práticas discursivas de regulamentação e liberdade no processo de desenvolvimento profissional: a constituição de subjetividades de professores na Revista Nova Escola

This present thesis has the object to study the discursive constitution the teacher s subjectivities of practice permeating the sections of the magazine Nova Escola between the years 2000-2005. Problematizes how the teacher s subjectivities are produced facing the discourse of truth, which effects establishes a program for autonomist professional development in a perspective of neo-liberal governmentality. Then from this uneasiness arises some requisite questions: in the new century how teacher s subjectivities are discursively produced in magazine s sections Nova Escola during those five years of governmentality? In which perspective the discourses throughout government documents in related with professional development reflect in the linguistic-discursive repertories adopted by Nova Escola? How the experts belonging to the cadre from and/or guests from the magazine, seeking equip discursive the teacher s subjectivities for the XXI Century? Therefore, this paper objective is to examine the linguistics strategies used to produce these subjectivities at magazine s sections, what it admittedly teaches another method how to be teacher; and also it analyzes the discursive practices that compound and set boundaries to the autonomist professional development proposed by sections the magazine; describe technologies used by experts to equip and conduct of conduct the teacher to govern the self. This research is inserted theoretically in the field of Applied Linguistis, to the Cultural Studies and about the contribution of Michel Foucault s theories and methodologically in the perspective discursive interpretative. The results seek to show that the teacher s subjectivities are produced by many technologies of the self, traversed by government discourses and ratified by discursive practices of the magazine s experts. That discourse, without any oppressing or authoritarian connotation, opens space for practice of Freedom and self guiding to both constitute the subjectivity process of the teacher in the XXI Century s path

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.

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

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...

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.