產品標準在現今社會中扮演非常重要的角色，但也容易造成許多技術性貿易障礙。醫藥產品由於攸關人類身體的健康及安全，因此相較於其他行業，各國對藥品皆設有許多嚴格的產品標準及技術法規，對藥品的國際貿易產生嚴重的技術性貿易障礙。PIC/S制定共通的GMP標準，並且旨在降低醫藥產品在國際貿易及流通上所面臨的非關稅貿易障礙。台灣藥物食品檢驗局於2007年公告實施PIC/S GMP，預計於2013年開始全面實施。本研究關注的核心議題，主要將以WTO對技術性貿易障礙的主要規範原則，分析探討PIC/S降低醫藥產品技術性貿易障礙的功能。另外，台灣製藥業由於缺乏關鍵技術、藥廠家數眾多、生產規模小，惡性競爭十分激烈，未來實施PIC/S GMP後，對我國製藥業的衝擊不容小覷，因此本研究另一項主要議題是PIC/S GMP對我國製藥業及藥品貿易之可能影響。 / Product standards play an important role in modern societies. However, they also raise many concerns about technical barriers to trade, particularly for pharmaceutical products which must comply with numerous stringent product standards, such as GMP standards. Therefore, PIC/S aims at reducing the technical barriers to pharmaceutical trade by providing a common GMP standard, which the Bureau of Food and Drug Analysis of Taiwan declared to introduce PIC/S GMP in 2007, and to fully enforce in 2013. This study will examine how PIC/S decreases technical barriers to trade for pharmaceutical products with principals in the WTO TBT Agreement. In addition, since Taiwan pharmaceutical industry has low competitiveness for a long time, how PIC/S GMP will affect the pharmaceutical industry and international trade of Taiwan is another main issue of this study.

在各大藥廠明星藥品專利到期、新藥開發數量銳減的當下，全球首例植物新藥MediGene Veregen™ 的核准上市為製藥產業帶來新的希望，雖然製藥價值鏈與商品化模式已為人所熟知，但針對植物新藥特殊性所架構之商品化模式還是一個全新的議題，為了架構一個適合台灣中小型藥廠的植物新藥開發模式，本研究嘗試以技術層面為根基，從法規面、產品面與產業面深入探討MediGene Veregen™ 關鍵的成功因素，從中獲取值得台灣藥廠參考的經驗，同時考量台灣植物新藥開發的大環境限制因素，包括法規與健保，給予台灣藥廠一些植物新藥商品化策略建議。 本研究之架構以實務觀點出發，首先整理參考文獻以探討植物新藥包含的範圍與藥品開發流程，幫助藥廠了解植物新藥商品化需要具備的條件與資訊；接著針對台灣與美國在植物新藥方面審查上市之法規、流程與審核成果進行研究，結果顯示目前台灣有兩種植物新藥審查系統「中藥新藥」與「植物抽取新藥」，對廠商而言並不如美國單一系統來得便利；再者藉由探討植物新藥的價值鏈結構、法規結構、產品結構與產業結構，試圖架構植物新藥商品化模式；接下來以兩家新藥開發廠商為例進行實際個案研究，一家為成功推出植物新藥商品的德國藥廠MediGene AG，一家為台灣藥廠中天生技/合一生技，主要藉由分析MediGene Veregen™ 商品化過程的關鍵成功因素，比較中天生技/合一生技WH-1商品化模式的異同，探討是否有足以借鏡與改進之處。最後，歸納整理上述的研究做出結論，並且對於台灣藥廠提出策略建議，希望能對於台灣新藥開發公司有實質上的幫助。 / While the star drug patents of each big pharmaceutical company are expired one after another and the quantity of their newly developed drugs sharply declines in these years, MediGene Veregen™, the first botanical new drug in the world, enters the market and therefore brings a new hope for the pharmaceutical industry. Although the value chain and the commercialization model of pharmaceutical industry have been known and researched a lot, the specific construction of commercialization model for botanical drugs is still a brand new subject. In older to construct the model that is suitable for Taiwanese middle and small pharmaceutical companies for the process from development to commercialization of botanical new drugs, this research, based on the technical analysis, attempts to discuss the key success factors of MediGene Veregen™ through analyzing the aspects of the laws, regulations, industry and product itself. With the case study about the environmental limited factors of new drug development in Taiwan, including the laws and regulations as well as the health insurance, this research tries to offer Taiwan pharmaceutical companies some strategic suggestions for the development and commercialization of botanical new drugs. The structure of this research is based on the practical viewpoints. First, we reorganize the reference in order to define the scope of botanical new drugs and the processes of drug development. It can help pharmaceutical companies understand the conditions and information needed for botanical new drug commercialization. Then, our studies focus on the laws and regulations in Taiwan and the United States, as well as the application processes and approvals for botanical new drugs. The results show that there are two evaluation systems in Taiwan for botanical new drug applications. For those pharmaceutical companies, the dual system is not as convenient as the sole evaluation system in the States. Furthermore; based on the discussion on the structure of the value chain, laws, regulations, product and industry, this paper makes an attempt to construct a better commercialization model of botanical new drugs. Next, two pharmaceutical companies are chosen as case study in this paper. One is a German pharmaceutical company, MediGene AG, which launched the first botanical new drug. The other is a Taiwan pharmaceutical company, MicroBio Co., Ltd/Oneness Bio-Tech Co., Ltd. By analyzing the key success factors in the commercialization process of MediGene Veregen™ and comparing its commercialization model with MicroBio Co., Ltd/Oneness Bio-Tech Co. WH-1, we try to get any valuable idea and insight. Finally, our conclusion and strategic suggestions may have solid help for Taiwan botanical new drug pharmaceutical companies.

Patent protection grants the patent holder with a market monopoly, free from market competition allowing the patentee to charge any price; therefore medicines are sold at prices much higher than the marginal cost of production and distribution. The connection between international trade and intellectual property has aggravated human rights and public health concerns surrounding the inaccessibility of essential medicines. The World Trade Organisation‘s Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement is an international instrument which has greatly impacted intellectual property rights protection and access to medicine. It has globalized intellectual property law by obliging all Members to subscribe to the minimum international standards of protection for intellectual property. South Africa is an example of the issues faced whilst attempting to bring their domestic laws into compliance with the Agreement. The government had to attempt to strike a balance between creating an effective intellectual property infrastructure whilst realizing the therapeutic needs of those affected by HIV/AIDS. The South African Patents Act 57 of 1978 did not comply with the Agreement and was subsequently amended in order to bring its patent legislation in full compliance with the Agreement. Currently, South Africa grants patents for new uses or formulations of existing medicines consequently lengthening the period of patent monopoly by allowing pharmaceutical companies to obtain new patents for slight modifications to existing medicines. It is submitted that South Africa‘s patent legislation is more extensive than is necessary under international law, examples of this being disclosure standards and the process for compulsory licensing. In addition, it has not made use of provisions in its existing law to take measures to improve access to essential medicines, nor has it implemented legislative amendments consequent to the flexibilities established in the Doha Declaration. This dissertation seeks to review the steps South Africa has taken in its compliance with the TRIPS Agreement with respect to the relevant intellectual property legislation that has been enacted, including its implications for access to essential medicines. The intention behind this dissertation is to assess the efficacy of the intellectual property legislation in South Africa and its impact on access to medicines. / Thesis (LL.M.)-Univeristy of KwaZulu-Natal, Durban, 2012.

[pt] As companhias farmacêuticas necessitam dirigir atenção à demanda crescente em trazer medicamentos ao mercado em uma forma econômica. A pressão sobre o preço está aumentando, e as vantagens de ter um período de exclusividade da utilização de suas patentes estão diminuindo, enquanto a produção de produtos genéricos está crescendo em todo mundo. Ter um portifólio de novas drogas é crítico, mas também é crítico ter habilidade de trazer essas drogas ao mercado em uma maneira eficiente e de baixo custo. Entretanto, as companhias farmacêuticas não podem mais contar unicamente em pesquisa e desenvolvimento e marketing para sobreviver, mas devem também confiar nos valores agregados pela gestão da cadeia de suprimentos (Supply Chain Management - SCM). Neste contexto, o presente trabalho tem o intuito de analisar o modelo de SCM global utilizado por uma grande empresa de medicamentos (Glaxosmithkline-GSK), através da apresentação das principais características de sua cadeia de suprimentos, da análise do planejamento e gerenciamento do suprimento e da demanda e da análise de práticas de SCM implementadas por esta empresa na Europa. / [en] Pharmaceutical companies need to address the growing demand for bringing medicines to market in an economical way. Price pressure is increasing, and the advantages of having a buffered patent window is decreasing as generic manufacturing is on the rise. Having a pipeline of new drugs is critical, but it is also critical the ability to bring them to market in a cost effective and efficient manner. However, pharmaceutical companies can no longer solely rely on research and development and marketing to survive, but must also rely on supply chain management to deliver value. Within this context, this dissertation intends to analyze the supply chain management model of a major pharmaceutical company (GlaxoSmithkline - GSK) throughout an overview of the key characteristics of its supply chain, supply and demand management and some examples of projects implemented in Europe.

En 1940, le biochimiste anglais Donald Woods propose une explication du mode d'action des nouveaux sulfamides antibactériens : l'inhibition compétitive. Son collègue Paul Fildes fonde sur cette base une nouvelle approche de la chimiothérapie, revendiquée comme rationnelle, un programme pour la recherche de nouveaux médicaments. Cette thèse explore l'impact de la théorie des antimétabolites, comme elle sera appelée, dans la recherche biochimique et pharmaceutique. La première partie retrace son élaboration dans le contexte de l'école de biochimie anglaise, puis sa reprise aux États-Unis à la suite de travaux menés en parallèle sur les vitamines. La seconde partie est consacrée au développement de deux programmes de recherche distincts dédiés aux antimétabolites, illustrant les modalités et fortunes divergentes d'appropriation de cette approche rationnelle. Le premier est une collaboration modeste entre le biochimiste Henry McIlwain et la firme pharmaceutique Glaxo pendant la guerre au Royaume-Uni. Le second consiste en la mise en place du programme de George Hitchings et Gertrude Elion chez Burroughs Wellcome aux États-Unis, souvent considéré comme l'origine du rational drug design actuel. La théorie des antimétabolites correspond aussi bien à l'ambition d'obtenir des chimiothérapies spécifiques qu'à un ensemble de pratiques dans le quotidien du laboratoire / In 1940, the British biochemist Donald Woods put forward an explanation of the mode of action of the new antibacterial sulfa drugs, competitive inhibition. His colleague, Paul Fildes, developed this work into a new approach to chemotherapy, which he qualified as a rational programme for drug discovery. This dissertation explores the impact of the theory of antimetabolites, as it came to be known, in biochemical and pharmaceutical research. The first part traces its development in the context of the British school of biochemistry and its further expansion in the United States following parallel research on vitamins. The second part deals with the construction of two distinct research programmes dedicated to antimetabolites, each one illustrating a different way of following this rational approach and their varying consequences. The first one is a modest collaboration between the biochemist Henry McIlwain and the Glaxo pharmaceutical company during the war in the United Kingdom. The second one corresponds to the establishment of George Hitchings' and Gertrude Elion's programme at Burroughs Wellcome in the United States, often considered as the origin of today's rational drug design. The theory of antimetabolites simultaneously embodied both the ambition of attaining specific chemotherapies, and a set of practices in day-to-day laboratory work

Uma das características mais marcantes da propriedade intelectual é a tensão existente entre interesses público e privado. Na seara das patentes, essa tensão se torna ainda mais evidente quando o objeto da propriedade privada é essencial à consecução de objetivos sociais, como é o claro caso dos medicamentos. Concebida para fomentar a inovação, oferecendo um crescente número de soluções aos problemas enfrentados pela sociedade, a patente deve servir de incentivo à atividade inventiva. Isso ocorre por meio do período de exclusividade concedido ao inventor, durante o qual somente ele está autorizado a explorar comercialmente o produto de seus esforços. Quando se trata de bens essenciais à manutenção da vida dos indivíduos, entretanto, a análise se torna mais complexa. Preços monopolísticos podem impedir o acesso a determinadas drogas e inviabilizar políticas de saúde pública, por exemplo. É o custo social de um sistema de proteção fundado no monopólio de exploração. A ausência de incentivos, entretanto, leva à ausência de investimentos em produtos inovadores (veja-se o claro exemplo das doenças negligenciadas), o que, por sua vez, também gera um custo social. Existe equilíbrio possível a essa equação? Ao regular como o conhecimento é compartilhado, e ao estabelecer limites ao que se pode (e não se pode) fazer com os produtos desse conhecimento, a propriedade intelectual assume papel central no debate que busca compreender a relação entre direito e desenvolvimento. É buscando contribuir para essa reflexão que a presente tese foi concebida. Pretende-se demonstrar que quando se olha para o desenvolvimento de forma integrada, o progresso econômico por si só deixa de ser suficiente para atender às necessidades de crescimento das nações. Logo, as justificativas econômicas ao sistema de proteção patentário também deixam de ser suficientes para, por si só, atenderem aos anseios de desenvolvimento dos mais variados países. O trabalho encontra-se estruturado em quatro capítulos principais. O primeiro apresenta o ambiente internacional no qual se dá, majoritariamente, a produção normativa em matéria de propriedade intelectual; bem como a trajetória que moldou o atual quadro brasileiro em matéria de patentes e acesso a medicamentos. O segundo capítulo analisa as principais teorias que justificam o sistema de patentes, bem como aquelas que evidenciam suas fragilidades, além de discutir alternativas possíveis de fomento à inovação. O terceiro capítulo, por sua vez, estabelece o conceito de desenvolvimento que pauta a análise central proposta pela tese e o quarto e último capítulo traça um desenho da realidade da indústria farmacêutica no Brasil, no qual fica evidenciado que a produção de novos conhecimentos, passíveis de gerar inovação na área da saúde, é uma das grandes fragilidades nacionais. Sob a ótica de uma concepção integrada de desenvolvimento, conclui-se que a atual estrutura normativa patentária, por não oferecer alternativas ao monopólio como fomento à inovação, é mais prejudicial do que benéfica ao desenvolvimento do país, sendo necessário conceber modelos alternativos de proteção que possam coexistir com o modelo vigente. / One of the most noteworthy features of intellectual property rights is the existing tension between public and private interests. Particularly in the field of patents, such tension becomes even more evident when the object of private property is key to the achievement of social goals, as is the clear case of medicines. Conceived to foster innovation and offer society an ever-increasing number of solutions to everyday problems, patents must function as real incentives to creative activity. This is feasible because for a limited period of time, the inventor is the sole detainer of the commercial rights to explore his invention. When goods are, as in the case of drugs, essential to people\'s lives, the analysis becomes much more complex. Monopolistic prices may hinder access to certain drugs and, thus, make public health policies more difficult. Based on monopoly rights, this protection system has social costs. Lack of economic incentives, on the other hand, may lead to shortage of investments in innovative products (see the case of neglected diseases, for instance), which also generates social cost. Is it possible to strike balance to this equation? By regulating how knowledge is shared, and by establishing limits to what can and cannot be done to knowledge products, intellectual property rights take on a key role in the debate that seeks to understand the relationship between law and development. This dissertation aims at contributing to such discussion, by primarily demonstrating that when development is conceived in a holistic manner, economic progress in itself no longer suffices nations. Thus, the economic rationale used for the patent system also ceases to fulfill development goals in a significantly increasing number of countries. The dissertation is divided into four main parts. Chapter one portrays the international environment in which most intellectual property issues are regulated, as well as the historical and political routes that led to the current Brazilian legal framework of patents and access to medicines. Chapter two analyses the main legal and economic theories that justify the existence of the patent system, as well as those that evidence its shortcomings. It further presents and discusses existing alternative options that may encourage innovation in this area. Chapter three establishes the concept of development that is central to the dissertation\'s main analysis, while chapter four tells the story of pharmaceutical production in Brazil. The central line traced through the dissertation makes it then possible to demonstrate how national knowledge production that may lead to pharmaceutical innovations is one of the country\'s main limitations. The use of a holistic view of development leads to the conclusion that the current patent framework is, in fact, inadequate and produces more damage than benefits to the development of Brazil, to the extent that it does not offer alternative solutions to monopoly power. Different incentive models that can coexist with the current system are, in this sense, desiderata.

L'étude théorique de l'impact de la brevetabilité sur l'innovation pharmaceutique révèle des relations ambivalentes. D'où l'intérêt de cibler l'étude sur un pays en particulier. La croissance notable que connaît l'industrie pharmaceutique locale, l'accent mis par l'Etat sur le développement de la R&D et de l'innovation pharmaceutique et l'abscence d'études antérieures sur cette question, sont autant de facteurs qui font de la Tunisie un cas intéressant pour analyser l'impact de la brevetabilité des médicaments sur l'innovation pharmaceutique locale. Après avoir analysé le potentiel d'innovation pharmaceutique endogène et exogène en Tunisie, d'abord, à travers une analyse descritive du Système Sectoriel National d'Innovation (SSNI) en Tunisie, puis à l'aide d'une enquête menée auprès des laboratoires pharmaceutiques locaux, nous avons construit un indice mesurant leurs potentiels de l'innovation pour en déterminer l'impact la brevetabilité. Les résultats empiriques montrent que la brevetabilité n'est une incitation à l'innovation que si la firme (l'industrie ou l'économie) se transforme d'une "imitatrice nette" en une "innovatrice nette". L'analyse empirique montre que l'industrie pharmaceutique tunisienne étant encore "imitatrice nette", à court terme, la brevetabilité des médicaments a un impact négatif sur l'innovation locale et apparaît comme une réforme "prématurée" à ce stade de développement. Tandis qu'à long terme, l'impact dépendra de l'efficacité du SSNI à mettre en place des moyens alternatifs d'accès aux technologies nouvelles à travers la création d'une dynamique d'attractivité aux investissements étrangers "innovation seeking". Les développements théoriques, les résultats empiriques et les enseignements tirés d'expériences étrangères suggèrent que ceci est d'autant plus réalisable que la Tunisie adopte une politique technologique plus ciblée et mieux réfléchie pour créer un véritable "marché" de l'innovation pharmaceutique, et ce à travers la dynamisation des interactions entre les acteurs publics et privés du SSNI. / The theoretical study of the impact of patentability on pharmaceutical innovation reveals ambivalent relationships. Thus, it is interesting to target the analysis on a particular country. The notable growth of the local pharmaceutical industry, the emphasis put by the State on the encouragement of pharmaceutical R&D and the absence of previous studies on this issue, are as many factors that make from the Tunisian pharmaceutical industry an interesting cas study of the impact of drugs patentability on pharmaceutical innovation. After having studied the endogenous and exogenous innovation potential in Tunisia, first throughout an analysis of the sectoral national innovation system (SNIS), then according to a survey led next to the pharmaceutical laboratories in Tunisia, we have constructed an index measuring their innovation potential and performances and determined the impact of patentability. The empirical results show that patentability is an incentive for innovation only if the firm (industry, economy) transforms from a "net imitator" into a "net innovator". The Tunisian pharmaceutical industry being at a stage of a net imitator, drugs patentability generates a negative effect on local innovation on the short run and seems a premature reform in Tunisia. However, in the long run, the impact depends on the efficiency of the SNIS in putting into effect alternative means to access new technologies by creating a dynamic of attraction towards pharmaceutical foreign investments "innovation seeking". The theoretical developments, the empirical results and the lessons taught from foreign experiences suggest that this is as much realizable as the Tunisian state adopts a technological policy more targeted and better thought in a sense of creating a genuine "market" for pharmaceutical innovation, throughout valorizing the human capital and boosting the interactions between the public and private actors of the SNIS.

Made available in DSpace on 2016-08-10T10:29:30Z (GMT). No. of bitstreams: 1 ZELIA APARECIDA BORGES DE OLIVEIRA.pdf: 16175730 bytes, checksum: 2abd35c7784ef9b27301efa3863124d6 (MD5) Previous issue date: 2008-04-03 / This is a study for the implementation of the Environmental Management System in the pharmaceutical industry Neo Química, located in the Agroindustrial District (DAIA) in Goiás. The ISO 14001(2004) fundamentals, specifications of the Environmental Management System (EMS), which will be used as a judgment standard, were applied in the company. The methodology used follows the parameters of the ISO 14001 (2004) norm in all stages and contemplated: bibliographical research and consultation of technical articles; use of specific regulations, data-collecting; identification of environmental aspects and impacts and interviews. Diagnosis concluded that the company maintains an approved Environmental Policy, complies with the requirements of environmental legislation, and besides a social environmental program which, through recycling, permitted reduction in almost 70% of the amount of waste produced monthly, owns an Industrial Waist Treatment Facility. The main results observed during the initial implementation stage of the Environmental Management System were: reduction of the water and energy consumption, improvement of the environmental performance and the approval of projects significant to the reduction of environmental impacts. Based on the presented indicators, the reduction of operational costs and environmental improvements as result of the implementation of an EMS in the pharmaceutical industry are evident. / Este é um estudo para implantação do Sistema de Gestão Ambiental na indústria farmacêutica Neo Química, localizada no Distrito Agroindustrial de Anápolis (DAIA) em Goiás. Foram aplicados na empresa os fundamentos da ISO 14001(2004), especificações do Sistema de Gestão Ambiental (SGA), que será a norma em relação a qual será julgado. A metodologia utilizada segue os parâmetros da norma ISO 14001 (2004), em todas as suas etapas e contemplou: pesquisa bibliográfica e consulta a artigos técnicos; utilização de legislações específicas, levantamento de dados; identificação de aspectos e impactos ambientais e entrevistas. No diagnóstico realizado constatou-se que a empresa possui uma Política Ambiental aprovada, atende aos requisitos da legislação ambiental para licenciamento e funcionamento, conta com Estação de Tratamento de Despejos Industriais (ETDI), além de um programa sócio ambiental, que levou à redução dos resíduos, pela reciclagem, em quase 70% do total gerado mensalmente. Os principais resultados encontrados com o início da implantação do Sistema de Gestão Ambiental foram: redução do consumo de água e energia, melhoria do desempenho ambiental e a aprovação de projetos significativos para a redução de impactos ambientais. Com base nos indicativos apresentados é evidente a redução de custos operacionais e ganhos ambientais com a implantação de um Sistema de Gestão Ambiental na indústria farmacêutica.

Made available in DSpace on 2016-08-10T10:29:32Z (GMT). No. of bitstreams: 1 SILVIA GOMES PEREIRA DE SOUZA AZZI.pdf: 1304121 bytes, checksum: 4696f55ed28df961b236f574163e4663 (MD5) Previous issue date: 2009-03-20 / This thesis presents the results of a study in Chemical Industry of the State of Goiás S/A (IQUEGO), aiming to diagnose the occurrence of accidents in the workplace, in the period from 2000 to 2007. The problem discussed concerns the relations between the conditions and organization of work as being facilitators of the occurrence of accidents from the assumption that, knowing the risk factors involved in labor activities in the pharmaceutical industry, you can see a strategy aimed at reducing the current rate of accidents at work. First, an analysis was made of the profile of the employee victim, type of activity carried out in business, time distribution of accidents, body parts affected and causes of accidents and injuries. We tried to verify the relationship between the accident and profile of affected workers and the working conditions of the area where they work in accordance with the personnel management policies adopted in the company. The method adopted for the research was the case study. Data were collected from a compilation of accidents reported through communication of Occupational Accidents (CAT), available in the collection of documentary industry. The research shows that the productive sector has a range of diversity of jobs and tasks. Organized in two shifts, the pace of work is intense, with continuous and repetitive movements of body parts, forced postures, intense rotations of trunk and head and legs of inflections, which makes the environment conducive to accidents. Under health and safety of workers, found that the organization adopts a policy not very well formalized, but supports the activities prevention ongoing, as the recommendations of Good Manufacturing Practices (GMP) and the legal concepts. The findings point to the need of the pharmaceutical industry, field of research, preventive care and has the standard of management, that invests in health and safety, improving working conditions, preserving the dignity of their workers. / Esta dissertação apresenta os resultados de uma pesquisa realizada na Indústria Química do Estado de Goiás S/A (IQUEGO), com o objetivo de diagnosticar a ocorrência de acidentes no ambiente de trabalho, no período de 2000 a 2007. A problemática discutida refere-se às relações entre as condições e a organização do trabalho como elementos facilitadores da ocorrência de acidentes, a partir do pressuposto de que, conhecendo os fatores de riscos inerentes às atividades laborais da indústria farmacêutica, pode-se vislumbrar uma estratégia voltada à redução dos índices de acidentes no trabalho. Em primeiro plano, procedeu-se a análise do perfil do trabalhador vitimado, tipo de atividade exercida na empresa, distribuição temporal dos acidentes, partes do corpo atingidas e causas dos acidentes e das lesões. Buscou-se verificar a relação entre os acidentes e o perfil dos trabalhadores vitimados, bem como as condições de trabalho da área em que atuam, de conformidade com as políticas de gestão de pessoal adotadas na empresa. O método adotado para a investigação foi o estudo de caso. Os dados foram coletados dos registros dos acidentes relatados por meio de Comunicação de Acidente de Trabalho (CAT), disponíveis no acervo documental da indústria. A pesquisa revelou que o setor produtivo possui uma gama de diversidade de postos de trabalho e tarefas executadas. Organizado em dois turnos, o ritmo de trabalho é intenso, com movimentação contínua e repetitiva de partes do corpo, posturas forçadas, rotações intensas de tronco e cabeça e flexões de pernas, o que torna esse ambiente propício à ocorrência de acidentes. No âmbito da saúde e segurança do trabalhador, constatou-se que a organização não adota uma política própria de prevenção devidamente formalizada, mas apóia as atividades prevencionistas em curso, conforme as recomendações das Boas Práticas de Fabricação (BPF) e as concepções legais sobre o assunto. As conclusões apontam para a necessidade de a indústria farmacêutica, campo da pesquisa, ter o cuidado preventivo como norma de gestão, investir em saúde e segurança, no sentido de melhorar as condições de trabalho, preservando a saúde e a dignidade de seus trabalhadores.

Made available in DSpace on 2015-12-03T18:32:54Z (GMT). No. of bitstreams: 1 Waldir_Eschberger_Junior.pdf: 483800 bytes, checksum: 67f2552e71c518a11a9bb4e30f782797 (MD5) Previous issue date: 2006-11-29 / This work has sought to identify the relationship between management's mobilization styles and the productivity of the sales force in a pharmaceutical company. Sales Managers from large pharmaceutical companies were studied. The individual mobilization style of each manager was identified through the M.A.R.E.?? Motivational Guidelines and afterwards correlated to the marks given for productivity to his/her team as supplied by their individual companies, in order to identify the existing relationship between the results of the teams and the mobilization style of each of their leaders. It was noticed during the study that there was a great difference in behavior as regards the challenges faced by the team members on a day-to-day basis and how much the human factor was responsible for the results obtained. In order to adequately reflect on the leadership theme, this study was based on authors such as Bass, Bennis, Burns, Machiavelli, Nannus and Spector. As regards the motivational aspects, the authors chosen for reflection were Alderfer, Herzberg, Maslow, McClelland, McGregor, Mitchel, Sinha, Vroom, Zoltners and Zoltners. The Mobilization Styles identified were based on contributions made by Coda and Ricco as well as studies carried out by Erich Fromm. The use of performance indicators has facilitated the identification of the results of each team for comparison to the Mobilization Styles. This factor determines the importance of the use of standard criteria so as to have an appropriate measurement of the people evaluated as well as give fairness to the process and guarantee credibility in the system to those involved. The study shows that certain mobilization styles are associated to favorable sales results, whereas other styles are not as favorable to a better performance of the teams. The study associates better productivity to the Competitive style and demonstrates that the Collaborative style is not conducive to adequate results for the sales teams of pharmaceutical products. The results obtained suggest towards a continuity of this study, initially in institutions working in the same field as the one studied here, so as to verify the data identified. Afterwards, attempting to corroborate the relationship between Managers and Mobilization Styles in the sales areas of companies in other segments, and finally searching for this relationship in other areas of the company. / Este trabalho procurou identificar a rela????o entre o estilo de mobiliza????o do gestor e a produtividade da for??a de vendas de uma empresa do ramo farmac??utico. Foram estudados Gerentes de Vendas de uma grande Ind??stria Farmac??utica. Cada Gerente teve identificado seu Estilo de Mobiliza????o atrav??s do Diagn??stico M.A.R.E.?? de Orienta????es Motivacionais e este relacionado ??s notas dadas ?? produtividade de sua equipe fornecidas pela empresa, buscando identificar a exist??ncia de uma rela????o entre o resultado da equipe e o estilo de mobiliza????o de seu l??der. No decorrer deste estudo percebeu-se a grande diferen??a de comportamento das pessoas frente aos desafios do dia-a-dia de uma empresa e quanto o fator humano tem sido respons??vel pelo resultado obtido. Para possibilitar uma adequada reflex??o sobre o tema de lideran??a, este estudo est?? baseado em autores como Bass, Bennis, Burns, Maquiavel, Nannus e Spector e quanto aos aspectos de motiva????o os autores escolhidos foram Alderfer, Herzberg, Maslow, McClelland, McGregor, Mitchel, Sinha, Vroom, Zoltners e Zoltners. Os Estilos de Mobiliza????o identificados s??o baseados nas contribui????es de Coda e Ricco aos estudos de Erich Fromm. A utiliza????o de indicadores de performance facilitou a identifica????o dos resultados das equipes para compara????o aos Estilos de Mobiliza????o. Este fator determina a import??ncia da utiliza????o de crit??rios padr??es para que haja uma mensura????o adequada das pessoas avaliadas, dando justi??a ao processo e garantindo aos envolvidos credibilidade no sistema. O estudo mostra que determinado estilo de mobiliza????o esta associado a resultados favor??veis de vendas, mas em contrapartida outros estilos n??o favorecem um melhor desempenho de suas equipes. O estudo associa melhor produtividade ao estilo Competidor e demonstra que o estilo Colaborador n??o est?? ligado a resultados adequados para equipes de vendas de produtos farmac??uticos. Os resultados obtidos sugerem a continuidade desta pesquisa , inicialmente em institui????es de mesmo ramo de atividade da que foi aqui estudada, visando confirmar os dados identificados, e posteriormente buscar evidenciar a rela????o entre Gestores e Estilos de Mobiliza????o na ??rea de vendas de empresas de outros segmentos, e finalmente buscar esta rela????o em outras ??reas das empresas.