Thesis (Ph. D.)--University of Chicago, Graduate School of Business, August 2002. / Includes bibliographical references. Also available on the Internet.

Laws and regulations are controlling and have generated great impact on the pharmaceutical industry and putting high requirements on production to follow good manufacturing procedures. There is a high pressure on production to decrease the time-to-volume for new products implementations due to the long product development phases where the medicine product patent life only have 35-40% left when production can start. This have generated that production have applied a way of thinking when developing production lines that have a tendency of becoming a scale up over time where a new production line is added to the production plant to be able to produce the volume needed for customers. Astra Zeneca, one of the largest pharmaceutical companies in the world, predicts a future where they will need to handle more products launches parallel where the new product will be produced both in small and large volumes to new customers. In this thesis a single case study have been performed at where a new product is being implemented, the project Genuair at Astra Zeneca Sweden operations in Södertälje. This thesis have be executing with the overall aim of supporting the development of a new layout, a functional layout. The project Genuair is a project where a new product is introduced in a new way, by buying a patent. The project is in the beginning of building the first production line that have a continuous flow layout and there is already a plan to build a second production line to be able to produce the needed volume. The predicted future for the Genuair products is in line with the general predicted future within Astra Zeneca generating a need for higher volume flexibility and higher product-mix flexibility. This change will have an impact on the current Genuair production layout generating a decreasing of 45 % in volume output after analyzing the production line by building a simulation model. The current production layout is facing different limitations where long complex changeovers is the main reason for the decreasing in volume output. The current layout is also generating limitations where production is limited by equipment, vulnerable for shutdowns, laws and regulations and the need for fulfilling the capabilities of safety, health and environment, quality, deliverability and cost. A functional layout is presented that builds on achieving volume flexibility, product-mix flexibility and expansion flexibility. The introduction of a functional layout will generate challenges within the areas of laws and regulations, compliance, location of machines in different hygiene zones, traceability, material handling, the product-process matrix and the mind set within Astra Zeneca. The functional layout is analyzed by the development of a simulation model and compared to the current production layout and proven to handle the predicted future by primarily handling the changeovers in a different way that is the main limitation that follows by having a need for high volume flexibility and product-mix flexibility within the pharmaceutical industry. The functional layout will generate a higher degree of flexibility that will come to the expense of cost.

Material supply systems have for a long time been regarded as an important function with strong potential to increase the performance of companies in different industries. Consequently, substantial research has been conducted in the field. However, in the pharmaceutical industry within research and development plants, material supply systems have historically not been a prioritized function. Therefore, there is a research gap regarding material supply systems in that peculiar context. This study aims to fill that gap by investigating how a material supply system could be designed and which factors are critical to achieve a cost-efficient service level within a research and development plant in the pharmaceutical industry. To do so, a single case study has been conducted at a Swedish pharmaceutical company’s research and development plant. An abductive approach has been applied to both test if the general design principles developed in other industries and business functions can be applied to this context. Further, context specific factors affecting the material supply system design needed to be identified and investigated to adapt the general design principles to the specific context by generalizing data. The empirical data was collected by utilizing focus groups, interviews, observations and documents. The findings yielded that there is a substantial potential for improvement of material supply systems within the context of this study. The existing decentralized inventory structure at the case company was a particularly vital aspect that hindered the system from operating cost-efficiently in relation to the service level and a centralization is crucial to improve. Further, calibration and a general decrease of safety stocks, order points and order quantities is essential to uphold a consistent service level at a justifiable cost at the case company. The general design principles and formulas retrieved from the theoretical framework was partly applicable in the context of this study but needed some adjustments. Especially the low volume articles with high variety in consumption rate was not suitable to be managed by the existing methods and needed another approach. Further, the context establishes high requirements on system dynamics, it comes with boundaries due to laws regulating the industry, and companies in the context generally need to be better at aligning their design factors to the purpose. The result of this study adds valuable content to the research field and fills the gap for material supply systems in the context of research and development plants in the pharmaceutical industry. Further studies are needed in this field to investigate how articles with low and varying demands can be managed within material supply systems cost-efficiently and with high service levels.

A talidomida foi amplamente prescrita entre 1950 e 1960, em quase 50 países, como hipnosedativo não-barbitúrico e antiemético para indisposição matinal durante a gravidez, sendo em seguida fortemente controlada em função da ocorrência de sérios problemas de teratogenicidade. Nos últimos anos, vários esforços foram realizados no sentido de buscar identificar e elucidar as propriedades antiinflamatórias, imunomodulatórias e antiangiogênicas da talidomida. Na mesma direção, investigações clínicas foram conduzidas em pacientes com diversas doenças, como mieloma múltiplo, carcinoma renal, câncer de próstata, Síndrome da rejeição paciente-enxerto, entre outras. A talidomida possui um centro quiral e dois anéis amida em sua estrutura e é sintetizada como racemato, constituída por dois enantiômeros ativos: (+)-(R)- e (+)-(S)-talidomida. A talidomida racêmica apresenta duas formas polimórficas, alfa ( ) e beta ( ). Assim, a variabilidade observada em relação ao polimorfismo representa um ponto crítico se considerarmos o potencial de alteração de propriedades biofarmacêuticas em decorrência da predominância de um ou outro polimorfo. No Brasil o medicamento talidomida é fabricado exclusivamente pela FUNED – Fundação Ezequiel Dias, laboratório público do Estado de Minas Gerais que integra o Sistema Oficial de produção de Medicamentos do País. Neste contexto, este trabalho tem como principal objetivo a avaliação de características físicas, físico-químicas e tecnológicas dos polimorfos da talidomida, com ênfase nos ensaios de cristalização, dissolução, degradação e compressão. Os resultados deste trabalho contribuíram para um melhor entendimento da relação entre características cristalográficas e propriedades farmacêuticas, agregando uma base científica capaz de avaliar as diferenças existentes destes polimorfos e garantir o controle de qualidade adequado do produto final produzido em um Laboratório Oficial. Estes estudos contribuíram para o cumprimento de exigências regulatórias. / Thalidomide was widely prescribed between 1950 and 1960, in nearly 50 countries, as sedative and antiemetic for morning sickness during pregnancy. After the occurrence of serious problems of teratogenicity it was heavily controlled. Growing interest has been observed in recent years to identify and elucidate the anti-inflammatory, immunomodulatory and anti-angiogenic properties of thalidomide. In the same direction, clinical investigations have been conducted in patients with various diseases such as myeloma, renal carcinoma, and prostate cancer, among others. Thalidomide possesses a chiral center and two amide rings in its structure and is synthesized as racemate, consisting of two active enantiomers: (+)-(R)- and (+)-(S)-thalidomide. It is known that the racemic thalidomide has two polymorphic forms, alpha ( ) and beta ( ). Thus, the observed variability in relation to the polymorphism represents a critical point considering the potential of changes in biopharmaceutical properties due to the predominance of one of them. In Brazil thalidomide tablets are manufactured exclusively by FUNED – Fundação Ezequiel Dias, the public laboratory of the State of Minas Gerais, which integrates the Country's Official System of drug production. In this context, the objectives of this work are the assessment of physical characteristics, physicalchemical and technological properties of polymorphic forms of thalidomide, with emphasis on crystallization, dissolution, degradation and compression. The results of this work contributed to a better understanding of the relationship between characteristic crystallographic properties and pharmaceutical properties, aggregating a scientific basis to assess the differences of these polymorphs and ensure the appropriate quality control of the final product produced in an official laboratory. These studies contributed to compliance with regulatory requirements.

Submitted by Eduardo Gomensoro (eduardo.gomensoro@hotmail.com) on 2016-01-13T18:04:57Z No. of bitstreams: 1 Dissertação MEX 2014_Eduardo Eugênio Bittenourt de Gomensoro.pdf: 3249581 bytes, checksum: 6b2303bb623756497a892a0212462b9f (MD5) / Approved for entry into archive by Janete de Oliveira Feitosa (janete.feitosa@fgv.br) on 2016-01-14T19:17:31Z (GMT) No. of bitstreams: 1 Dissertação MEX 2014_Eduardo Eugênio Bittenourt de Gomensoro.pdf: 3249581 bytes, checksum: 6b2303bb623756497a892a0212462b9f (MD5) / Approved for entry into archive by Marcia Bacha (marcia.bacha@fgv.br) on 2016-01-21T13:35:05Z (GMT) No. of bitstreams: 1 Dissertação MEX 2014_Eduardo Eugênio Bittenourt de Gomensoro.pdf: 3249581 bytes, checksum: 6b2303bb623756497a892a0212462b9f (MD5) / Made available in DSpace on 2016-01-21T13:35:20Z (GMT). No. of bitstreams: 1 Dissertação MEX 2014_Eduardo Eugênio Bittenourt de Gomensoro.pdf: 3249581 bytes, checksum: 6b2303bb623756497a892a0212462b9f (MD5) Previous issue date: 2015-12-14 / In the pharmaceutical industry relationships based on trust are fundamental for work team function in all levels. There is a strong impact of change, and derived uncertainty, in the trust dynamics between the work teams and their motivation. In recent academic production, the liaisons between trust and performance have been explored and, particularly, we bring forth the results of the first empirical research conducted in Brazil to measure the interpersonal trust levels, trust indicators and employee commitment inside a representative sample of private sector Brazilian organizations. The organizations researched and compared by Prof. Marco Túlio Zanini were selected as being representative of the 'new' and 'old' economies, among which the main differentiators are the knowledge management and the high level of uncertainty secondary to the frequent organizational and environmental change. These aspects associate companies of the research-based pharmaceutical industry to companies of the 'new' economy, in accordance to Prof. Zanini’s study. Companies of the pharmaceutical industry are going to implement important changes in their ways of doing business in the coming years, most of all in which concerns their communication, promotion and management of commercial work teams, and this seems to be a particularly interesting time for a study like the described in this dissertation. The aim of this work was to determine the level of similarity between the trust indicators among a commercial workforce from the biotechnological product segment (vaccines) of a major global organization of the research-based pharmaceutical industry, and the indicators obtained from organizations of the 'new' economy. We intended to measure the interpersonal trust and commitment indicators among the commercial workforce of the organization, in order to access the effects of enterprise uncertainty upon them. Our research tools were a previously validated survey, conducted upon the whole promotional team (56 members) of a specific area of the studied organization; public and private company data (the company remains undisclosed and identified as Company 'J'), and complementary in-depth interviews with key managers of the subject team: national and regional managers. Some similarity was found between the trust and commitment indicators of the companies of the 'old' economy and the indicators from Company 'J', for most of the evaluations. Nevertheless, some resemblance was also found between the indicators from companies of the 'new' economy and Company 'J', most of all among the managers of the latter. This could be an indicator of the impact of some measures recently implemented by Company 'J', which could have increased organizational uncertainty and instability. From the acquisition, analysis and comparison of this indicators we propose some discussion on the impact of the recent changes implemented on the relational work contract within Company 'J' and the relative relational dynamics inside its commercial workforce. / Na indústria farmacêutica (IF) são fundamentais as relações de confiança nas equipes de trabalho em todos os níveis. Há um forte impacto das mudanças, e da consequente incerteza, na confiança entre as equipes e sua motivação. Na produção acadêmica recente, as relações entre confiança e desempenho são exploradas e, particularmente, temos os resultados da primeira pesquisa feita no Brasil para mensurar os níveis de confiança interpessoal, indicadores de confiança e comprometimento dos colaboradores dentro de grandes empresas privadas. As empresas estudadas, e comparadas pelo Prof. Zanini, foram representantes da 'nova' e 'velha' economia, entre as quais os grandes diferenciadores são a gestão do conhecimento e o nível de incerteza decorrente das frequentes mudanças. Estes são pontos que aproximam as empresas da indústria farmacêutica de pesquisa às da 'nova' economia segundo a abordagem proposta na pesquisa do Prof. Zanini. As empresas da indústria farmacêutica estarão implementando mudanças importantes em sua forma de conduzir o negócio, principalmente no que toca à comunicação, promoção e gestão das equipes comerciais nos próximos anos e este parece ser um momento particularmente interessante para uma pesquisa como esta. O objetivo deste trabalho foi determinar o nível de similaridade das equipes de propaganda (comerciais) do segmento de produtos biológicos (vacinas) de uma grande empresa multinacional da indústria farmacêutica de pesquisa, com os as equipes de empresas da nova economia. Pretendemos mensurar os níveis de confiança interpessoal, indicadores de confiança e comprometimento dos componentes das equipes comerciais da empresa, com vistas a examinar os efeitos das incertezas institucionais sobre os mesmos. As ferramentas de pesquisa foram: um formulário previamente validado aplicado aos 56 membros da força de vendas de uma área específica da empresa; dados públicos e privados da empresa (que permanecerá identificada como Empresa 'J') e entrevistas em profundidade com os gestores-chave da equipe sob avaliação: gerentes nacionais e distritais da força de vendas. Foi encontrada alguma similaridade entre os índices das empresas da 'velha' economia e os da empresa 'J', para a maioria das avaliações. Entretanto, alguma semelhança entre os índices da Empresa 'J' e os das empresas da 'nova' economia também foi evidenciada, sobretudo na avaliação dos gerentes desta. Isto poderia indicar o impacto de algumas medidas implementadas pela Empresa 'J' mais recentemente, que podem ter colaborado na geração de um ambiente de incerteza institucional e instabilidade. A partir da obtenção e comparação destes índices, são propostas considerações sobre as mudanças ocorridas nos contratos relacionais de trabalho dentro da Empresa 'J' nos últimos anos e sobre as dinâmicas aparentes nas relações de sua equipe comercial.

Made available in DSpace on 2015-08-19T13:52:52Z (GMT). No. of bitstreams: 2 2.pdf: 6249517 bytes, checksum: 33d31da982124bd94dd704386c611afa (MD5) license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5) Previous issue date: 2012 / Fundação Oswaldo Cruz. Instituto de Tecnologia em Fármacos/Farmanguinhos. Rio de Janeiro, RJ, Brasil. / Atualmente, a indústria farmacêutica encontra-se inserida em um cenário de acirrada competição, enfrenta custos crescentes de pesquisa e desenvolvimento e está submetida a maiores exigências regulatórias. Soma-se a este quadro, reduzida eficiência operacional. Neste contexto, torna-se importante que as empresas farmacêuticas busquem mensurar e melhorar o desempenho de suas operações e equipamentos. Mundialmente e em diversos segmentos industriais, o indicador de eficácia global de equipamentos (Overall Equipment Effectiveness, OEE) é adotado como métrica do desempenho de máquinas e linhas produtivas. Através de estudo de caso, aplicado à produção de Farmanguinhos, verificou-se que o emprego da OEE permite identificar e quantificar as perdas que afetam o funcionamento dos recursos produtivos, servindo de base para o desenvolvimento de ações de melhoria contínua. Na implantação do indicador é fundamental assegurar que os operadores responsáveis pela coleta dos dados assimilem os objetivos e conceitos da metodologia e sejam capacitados a classificar corretamente as perdas. A análise dos resultados de OEE evidenciou que os processos de troca de máquina (set ups) representaram os desperdícios de maior impacto sobre a disponibilidade dos equipamentos em estudo. Foi verificado que princípios da troca rápida de ferramentas (Single Minute Exchange of Dies , SMED) podem ser utilizados para redução do tempo destas operações. / Currently, the pharmaceutical industry is inserted in a scenario of fierce competition, facing rising costs of research and development and is subjected to increased regulatory requirements. Reduced operational efficiency is added to this picture. In this context, it is important that pharmaceutical companies strive to measure and improve the performance of its operations and equipments. Worldwide and in several industrial sectors, Overall Equipment Effectiveness (OEE) indicator is adopted as the performance metric of machines and production lines. Through case study, applied to Farmanguinhos production, it was verified that the use of OEE enables identifying and quantifying the losses that affect productive resources operation, providing the basis for the development of continuous improvement actions. In the indicator’s implantation it is fundamental to assure that operators responsible for data collection assimilate the purposes and concepts of the methodology and are able to classify the losses correctly. The analysis of OEE results revealed that set up processes represented the waste of largest impact on the availability of the equipments under study. It was verified that principles of Single Minute Exchange of Dies (SMED) can be used to reduce the time of these operations.

Made available in DSpace on 2015-08-19T13:52:54Z (GMT). No. of bitstreams: 2 7.pdf: 1259773 bytes, checksum: c014c0a8beba83eb25b192dcfc910ae7 (MD5) license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5) Previous issue date: 2012 / Fundação Oswaldo Cruz. Instituto de Tecnologia em Fármacos/Farmanguinhos. Rio de Janeiro, RJ, Brasil. / O papel e atuação de Farmanguinhos/FIOCRUZ, em parceria com o Ministério da Saúde, na produção de medicamentos com qualidade e eficácia para a população possuem reconhecimento nacional e internacional. Existe uma dependência em relação a um conjunto de fatores que integram poder econômico, questões sociais e bases legais, necessitando assim,como um de seus alicerces, de uma gestão estratégica competente, moderna, transparente e focada em resultados.Utilizando-se como referência a metodologia de gestão estratégica organizacional conhecida como Balanced Scorecard (BSC) e as exigências dos órgãos reguladores direcionadas às indústrias farmacêuticas, foi proposto um modelo de BSC para Farmanguinhos, representado na forma de Mapa Estratégico. Este modelo foi baseado nas diretrizes e fundamentos tradicionais da metodologia mencionada, com foco na administração pública. Foram realizadas, a partir de um questionário semi-estruturado, entrevistas junto a cinquenta e dois gestores de Farmanguinhos, com o propósito de levantar informações que fundamentassem a elaboração de um Mapa Estratégico. A partir das entrevistas foi realizado o tratamento das informações coletadas, sua classificação e organização das mesmas por temas importantes para a administração da Unidade. Os dados obtidos com o projeto permitiram a proposição de um Mapa Estratégico customizado para Farmanguinhos. O Mapa, apresentado neste estudo, é um instrumento a ser avaliado pela alta gestão da Instituição e necessita passar por um processo de validação antes de sua efetiva aplicação na rotina desta Instituição. A contribuição deste trabalho para a Unidade é o contínuo aprimoramento na condução das estratégias de Farmanguinhos. Pretende-se, com a elaboração desta proposta, contribuir com a gestão estratégica de Farmanguinhos, como unidade vinculada ao Ministério da Saúde, visando a obtenção de resultados necessários à uma indústria farmacêutica pública. Espera-se também que esta modelagem seja promotora de maior confiança e efetividade das suas ações, assim como, maior visibilidade, transparência, integração e controle social de suas atividades, com consequente melhora no atendimento frente às demandas do Ministério da Saúde. / The role and performance of the Farmanguinhos/FIOCRUZ, in partnership with the Health Ministry, in the production of quality and effectiveness medicines for population, possesses national and international acknowledgement. There is a reliance on a set of factors that include economic power, social and ethical issues and also legal bases, thus necessitating, as one of its foundations, a competent strategic management, modern, transparent and focused on results. Using as reference the organizational strategic management methodology known as Balanced Scorecard (BSC) and the requirements of regulators directed to pharmaceutical industries, it has proposed a BSC model for Farmanguinhos, represented as a Strategy Map. This model was based on the guidelines and rationale of the traditional method mentioned, with a focus on public administration. They were made, from a semi-structured questionnaire, interviews with fifty-two Farmanguinhos’s managers, for the purpose of gathering information to substantiate the development of a Strategy Map. From the interviews,it was carried out the processing of collected information, their classification and their organization by important issues to the unit administration. The datas obtained from the project allowed to propose a customized strategic map for Farmanguinhos. The map, presented in this study, isan instrument that will be evaluated by senior management of the institution and has to go through a validation process before its effective implementation in the institution routine. The contribution of this work is to drive the continuous improvement in the conduct of Farman guinhos’ strategies. The aim of this proposal is to contribute to the st rategic management of Farmanguinhos, as a unit under the Health Ministry,in order to obtain the required results to a pharmaceutical public industry. It is also hoped that this model will promote greater of confidence and effectiveness related to their actions, as well as greater visibility, transparency, integration and social control of its activities, with consequent improvement in the service meet according to demands of the Health Ministry.

A indústria farmacêutica, de um modo geral, manipula substâncias tóxicas, desenvolve atividades utilizando como matéria-prima um dos maiores bens da natureza, que é a água. Enfim, para produzir o medicamento em benefício do homem deixa como conseqüências, impactos ambientais consideráveis. Pretende-se mostrar que o segmento em questão, apesar de buscar se adequar às normas legais, como as da vigilância sanitária, ele é muito centrado na qualidade do produto, em detrimento dos aspectos ambientais, ainda que tendo disponível uma importante ferramenta para tal: A certificação de Boas Práticas de Fabricação (BPF) dos produtos farmacêuticos. A escolha do local da pesquisa foi o estado do Rio de Janeiro, por ser este, entre outros aspectos, um sítio onde historicamente se localizam empresas deste setor. O Rio de Janeiro e São Paulo são estados que congregam o maior número de fabricantes de medicamentos do país. Identificadas as indústrias foi realizado um levantamento para selecionar um grupo de empresas com características semelhantes. Como as grandes empresas deste segmento são dotadas de estrutura adequada à implantação de sistema de gestão ambiental, elas ficaram fora deste escopo. Também ficou fora da pesquisa o grupo formado por empresas que importam, embalam, comercializam, mas não fabricam os medicamentos e os produtores de fitoterápicos e veterinários. O resultado da pesquisa foi que as empresas privadas com número de empregados entre 50 e 500 e todas as públicas têm deficiência para atender aos requisitos ambientais legais, em outras palavras, as questões ambientais ficam restritas a Agência Nacional de Vigilância Sanitária (ANVISA / RDC-306) e aos processos de obtenção de licenças junto a Fundação Estadual de Engenharia do Meio Ambiente (FEEMA). Apenas uma dentre às vinte e oito pesquisadas tem Sistema de Gestão Ambiental SGA implantado. Como todos os fabricantes de medicamentos têm que cumprir as exigências da RDC-210, para obterem o Certificado de BPF e os registros dos medicamentos, assim eles já possuem a cultura, parte dos requisitos e a ferramenta necessária à implantação de um SGA de acordo com padrões voluntários como a NBR ISO 14001 (2004). Para comprovar tal evidência, o estudo apresentou o caso de uma empresa pública dotada de características inovadoras e cultura diferenciada, porque agrega colaboradores advindos de laboratórios privados. Tal empresa fabrica exclusivamente vacinas, biofármacos e reativos, sendo uma grande exportadora, sujeita à fiscalização internacional, como por exemplo, a da Organização Mundial da Saúde (OMS). Conclui-se que as empresas priorizam as questões da ANVISA e as ambientais precisam ser monitoradas e mitigadas. Um Plano de Ação para melhorias ambientais, visando à implantação de um SGA e a obtenção de um diferencial competitivo pode ser adotado, através da estrutura existente por força das exigências da ANVISA a qualquer empresa do setor farmacêutico / The pharmaceutical industry, in general, handling toxic substances, develops activities using as raw material one of the greatest natural resources: the water. Finally, to produce the medicine for the man benefits leave consequences and significant environmental impacts. The work intends to show that referred segments in spite is seeking to adapt the legal obligations, such as sanitary surveillance, it is emphasizing on the quality of the product, to the detriment of the environmental aspects, even though having available an important tool for that: The Good Manufacturing Practice (GMP) requirements for pharmaceutical products. The choice of the researchs place was the state of Rio de Janeiro, among any other reasons, a historically site where companies in this section are located. The Rio de Janeiro and São Paulo states are bringing together the largest number of manufacturers of medicines in the country. Once the companies were identified, we proceeded with a preliminary survey, in order to define a group of companies with similar characteristics. As large companies at this segment are gifted with appropriated structure to the implementation of the environmental management system, they were outside this scope. It was out of this research the group formed by companies that import, pack, sell, but not manufacture the medicines and phytotherapeutical and veterinarian producers. The result of this research was that the number of private companies with employees between 50 and 500 and all public have disabilities to attend the legal environmental requirements, in other words, environmental issues are restricted to Agência Nacional de Vigilância Sanitária (ANVISA / RDC-306) and the procedures for obtaining licenses from Fundação Estadual de Engenharia do Meio Ambiente (FEEMA). Only one out of twenty eight had searched have Environmental Management System (EMS) installed. Like all manufacturers of medicines must implement the requirements of the RDC-210 to obtain the certificate of GMP and the records of medicine, so they already have the culture, part of the requirements and the necessary tool to the settlement of an EMS in accordance with voluntary standards such as NBR ISO 14001 (2004). To prove this evidence, the study presented the case of public company gifted with innovative features and culture differently, because aggregates employees arising from private laboratories. This company manufactures exclusively vaccines, biopharm and reagents for diagnosis been a major export, subject to international inspections, such as the World Health Organization (WHO) for instance. It follows that companies prioritize the issues of ANVISA and environmental need to be monitored e mitigated. An Action plan for environmental improvements, addressing the EMS settlement and the achievement of a competitive differential can be done through the existing structure under the requirements of ANVISA to any company of the pharmaceutical sector

Various academic disciplines have attempted to explain the factors underpinning superior economic performance. Generally they neglect the realities of small states. The literature fails to clearly define a small state . Mainstream theories associate smallness with sub-optimality . Small states studies tend to be conditioned by a vulnerability complex. Yet, a good number of small states have an economic track record which is the envy of much larger states. This thesis adopts an interdisciplinary approach to investigate the theoretical explanations of superior economic performance, at both the state and firm level. Resource-advantage theory, which claims to be a general theory of competition, offers valuable insights in understanding the superior economic performance of small states. The field research follows Porter (1998) in studying the performance of particular industries to understand the competitiveness of nations. A qualitative, case study approach, involving both primary and secondary investigation, explores the performance of the pharmaceutical industry in Malta following the country s decision to join the EU. This work perceives a small state as an organisation with well-defined, but permeable, boundaries. This open system is characterised by both a lack of market power and a small population. Through the secondary field research a small number of higher-order resources, competencies and dynamic capabilities (RCDCs) are identified. The field research s findings affirm the relevance of these arch-RCDCs in creating competitive advantage for the pharmaceutical industry in Malta. It also elucidates the key role played by an external catalyst, foreign direct investment, to circumvent domestic limitations. The study finds that it is still relevant to study small states and that achieving a strategic fit between the resource base and international market opportunities is essential if small states are to enhance their market power and achieve a superior economic performance.

[pt] Diferentemente de várias pesquisas que estudam as diferenças de desempenho somente entre grupos estratégicos para verificar as implicações nos resultados das empresas devido ao posicionamento estratégico adotado, este estudo tem por objetivo examinar tais diferenças não só entre, mas também dentro dos grupos estratégicos para responder à esta mesma questão. Utilizando um banco de dados com informações da indústria farmacêutica brasileira no período de 1999 a 2002, esta pesquisa toma por base o estudo de Miller e Dess sobre tipologias para identificar os grupamentos existentes e as estratégias relevantes neste segmento industrial, buscando relacionar o posicionamento competitivo utilizado pelas empresas ao desempenho observado. Os resultados obtidos sugerem que os melhores desempenhos pertencem aos grandes laboratórios estrangeiros que fabricam medicamentos de marca e que utilizam estratégias simultâneas de baixo custo e diferenciação em um escopo amplo de atuação de mercado. Estes resultados mostram ainda indícios de que a tipologia de Miller e Dess descreve o posicionamento estratégico das empresas dentro da indústria farmacêutica brasileira melhor do que a tipologia de Porter. Por fim, o estudo sugere que nenhuma empresa possui vantagem competitiva pelo fato de estar posicionada como principal, secundária ou solitária dentro dos grupos estratégicos desta indústria. / [en] Unlike many researches that study performance differences only among strategic groups to verify the implications on firms results due to their strategic positioning, this study aims to examine such differences not only among, but also within strategic groups in order to answer the same question. Using a database that contains information about the Brazilian pharmaceutical industry from 1999 to 2002, this research employs Miller and Dess study about typologies as a base to identify existing groups and their relevant strategies in this industrial sector, and to relate the competitive positioning of firms to their achieved performance. Obtained results suggest that the best performances belong to foreign giant laboratories that produce branded drugs and that simultaneously utilize low cost and differentiation strategies with a broad market orientation. Furthermore, the aforementioned attained results show strong indicia that Miller and Dess typology describes strategic positioning of firms within the Brazilian pharmaceutical industry better than Porter s typology does. Finally, this study suggests that no company has competitive advantage because of its positioning as a core, secondary or solitary firm within the strategic groups of this industry.