Made available in DSpace on 2016-04-18T18:50:03Z (GMT). No. of bitstreams: 2 Joao Paulo Cavalcante Lima1.pdf: 2792912 bytes, checksum: 5e2dacb5ddc13342ab20c0100dee96df (MD5) Joao Paulo Cavalcante Lima2.pdf: 1725929 bytes, checksum: e89c44c30b15d52346ce7dc6d8c19041 (MD5) Previous issue date: 2010-08-03 / Fundo Mackenzie de Pesquisa / According to the Resource Based View (RBV), Human Resources (HR) are presented as a major factor in the search for competitiveness. Therefore, it is common to find studies that show people as valuable resources, rare, non-replaceable and non-imitable. Thus, people are considered, at least in discourse, such as Intellectual Capital, as scarce and hardly imitable, are seen as generators of value and therefore, as a strategic resource and source of competitive advantage. This study sought to identify those attributes relevant to the management of Intellectual Capital, according to the perception of managers of Sanofi Aventis Brazil from the perspective of the Resource Based View (RBV) in order to propose indicators for the management of these elements, aligned economic environment of the pharmaceutical industry. The research is a case study, supported by a protocol, and which held the triangulation of information obtained in the content analysis of interviews and statistical analysis of data obtained by questionnaire. Factor analysis was used for data reduction. The results showed that there is alignment between the perception of senior management with an insight into operational management. / De acordo com a Visão Baseada em Recursos (VBR), os Recursos Humanos (RH) são apresentados como um dos principais fatores na busca por competitividade. Diante disso, é freqüente encontrar-se estudos que apontam pessoas como recursos valiosos, raros, não-substituíveis e não-imitáveis. Assim, as pessoas são consideradas, ao menos no discurso, como Capital Intelectual, como recurso raro e dificilmente imitável, são vistas como geradoras de valor e, portanto, como recurso estratégico e fonte de vantagem competitiva. Este estudo buscou identificar quais são os atributos relevantes para a gestão do Capital Intelectual, de acordo com a percepção dos gestores da Sanofi Aventis Brasil sob a ótica da Visão Baseada em Recursos (VBR) de forma a se propor indicadores de gestão desses elementos, alinhado ao ambiente econômico de uma indústria farmacêutica. A pesquisa é um estudo de caso, apoiado em um protocolo, e para a qual realizou-se a triangulação das informações obtidas na análise de conteúdo das entrevistas e nas análises estatísticas dos dados obtidos com o questionário. Foi usada a análise fatorial para redução dos dados. Os resultados apontaram que existe alinhamento entre a percepção da alta gestão com a percepção da gerencia operacional.

O controle sanitário no Brasil merece elevado nível de consideração, pois caracteriza-se por grande importância social e econômica. Abrange um leque grande de produtos e serviços de diversas naturezas, como: medicamentos, alimentos, produtos biológicos, vacinas, hemoderivados, saneantes e desinfetantes, produtos de higiene pessoal, perfumes e cosméticos, controle dos portos, aeroportos, estações de fronteiras e uma ampla variedade de serviços à saúde. A Agência Nacional de Vigilância Sanitária (ANVISA) foi criada no Brasil especificamente conforme artigo 3º da Lei nº 9782/1999, sendo relativamente recente comparando-se com as agências regulatórias no âmbito internacional, e desde então evoluiu, angariando respeito no nível nacional e internacional. Outras agências reguladoras igualmente importantes abrangem variedades de produtos e serviços semelhantes à ANVISA. Inclusive a Food and Drug Administration - (FDA) e a European Medicines Agency (EMA) apresentam em seu \"rool\" de medicamentos os veterinários, enquanto que no Brasil este tipo de produto é regulamentado pelo Ministério de Agricultura, Pecuária e Abastecimento (MAPA). O processo de registro no sistema de vigilância sanitária é um recurso de grande valia para assegurar a comercialização de produtos seguros e eficazes disponíveis à sociedade. Qualquer falha na cadeia produtiva pode impactar nos critérios de qualidade. Assim, a regulamentação sanitária sobre medicamentos abrange toda a cadeia farmacêutica desde o início dos estudos de pesquisa clínica até normas referente à publicidade. O objetivo desse trabalho é contribuir na promoção do conhecimento de regulação sanitária para os medicamentos pelo estudo da estrutura organizacional e atribuições da ANVISA, e paralelamente, efetuar a análise e comparação da regulamentação sanitária entre as diferentes categorias de medicamentos, bem como discutir a estratégia regulatória adotada pelo setor farmacêutico. Como material dessa pesquisa, empregou-se essencialmente, a regulamentação sanitária farmacêutica nacional, tendo como contrapontos a situação política e econômica do país, pautando-se como método a pesquisa qualitativa utilizando-se do modelo documental. Com vistas à estrutura organizacional das agências reguladoras de medicamentos descritas neste trabalho, verificou-se semelhanças inerentes as concepções técnicas e regulatórias, diferenciando-se, principalmente, da brasileira pelo fato dos medicamentos de uso humano e veterinário não estarem contemplados sob a responsabilidade da mesma instituição. Dentre as sete categorias de medicamentos estudadas, a composição técnica de seus dossiês de registro são consideravelmente análogas, sendo distintas as exigências regulatórias tangíveis aos quesitos específicos inerentes a cada tipo de medicamento. No período analisado (2009 a 2010), com o intuito de retratar a tendência regulatória adotada pelo setor farmacêutico brasileiro, as categorias de medicamentos genéricos e similares são as que mais apresentaram solicitações e deferimentos de registros no país. / The sanitary control in Brazil deserves a high level of consideration, because it is characterized by large social and economic importance. It encompasses a wide variety of products and services of various natures, as medicines, food, biological products, vaccines, blood products, sanitizing and disinfectants, toiletries, perfumes and cosmetics, control of ports, airports, frontiers stations and an extensive variety of health services. The National Agency for Sanitary Surveillance (ANVISA) was created in Brazil specifically as Article 3 of Law No. 9782/1999 and is relatively recent compared with regulatory agencies internationally, and has since evolved, gaining respect in the national and international level . Other regulatory agencies equally encompass important varieties of products and services similar from ANVISA. Even the Food and Drug Administration - (FDA) and European Medicines Agency (EMA) in its present \"rool\" medicine veterinarians, while in Brazil this type of product is regulated by the Ministry of Agriculture, Livestock and Supply (MAPA). The registration process in health monitoring system is a very valuable resource to ensure that commercialization of safe and effective products available to society. Any failure in the supply chain can impact on the quality criteria. Thus, the sanitary regulation on medicines covers the entire pharmaceutical chain since the early clinical research studies relating to the advertising standards. The objective of this work is to contribute in promoting knowledge of sanitary regulation for medicines by studying the organizational structure and responsibilities of ANVISA, and in parallel, perform analysis and comparison of the sanitary regulation between different categories of medicines, as well as discuss the regulatory strategy adopted by the pharmaceutical industry. As material of this research, we used essentially the national pharmaceutical the sanitary regulation, having as counterpoints the political and economic situation of the country, basing itself as a qualitative research method using the model document. With views to the organizational structure of drug regulatory agencies described in this study, it was found similarities inherent in the concepts and techniques regulatory, differentiating itself mainly by the fact that the Brazilian medicines for human and veterinary use are not covered under the responsibility of the same institution. Among the seven categories of drugs studied, the technical composition of their registration dossiers are considerably analogous, with different regulatory demands tangible to specific questions related to each type of medicine. In the analyzed period (2009 to 2010), in order to portray the regulatory trend adopted by the Brazilian pharmaceutical sector, the categories of generic medicines and similar are the ones that submitted more requests for deferrals and registries in the country.

Submitted by Marcia Silva (marcia@latec.uff.br) on 2016-05-02T18:41:36Z No. of bitstreams: 1 Dissert Patricia Gomes Ribeiro.pdf: 2222922 bytes, checksum: 4f188ecf66a2190db1619a4f92dcf57c (MD5) / Made available in DSpace on 2016-05-02T18:41:36Z (GMT). No. of bitstreams: 1 Dissert Patricia Gomes Ribeiro.pdf: 2222922 bytes, checksum: 4f188ecf66a2190db1619a4f92dcf57c (MD5) Previous issue date: 2015-12-16 / No ambiente dinâmico e complexo da indústria farmacêutica brasileira, caracterizado pela intensa competição e pelas significativas margens de lucro, o lançamento de medicamentos eficazes, seguros e inovadores se torna um dos principais determinantes do sucesso de muitas empresas do segmento. Todavia, o alcance do êxito neste contexto está associado não só à competência dos pesquisadores envolvidos e aos altos investimentos realizados, como também à resolução de possíveis entraves regulatórios e à supressão de barreiras técnicas inerentes a este processo. O presente estudo se propõe a analisar, destacando os pontos críticos, o impacto regulatório no desenvolvimento de novos produtos. O estudo está suportado pelo método de triangulação entre a fundamentação teórica, baseada na revisão da literatura técnico-científica, a análise da percepção e das evidências da amostra respondente do setor regulado, e a análise da percepção e das evidências da amostra respondente dos órgãos reguladores. Embora nesta investigação tenha se verificado a existência de entraves regulatórios, como a lentidão nas aprovações dos órgãos reguladores e a legislação frágil, também foram observados aspectos positivos no que concerne a mão de obra qualificada dos profissionais entrevistados desse setor e o investimento em inovação do setor regulado / In the dynamic and complex environment of the pharmaceutical industry, characterized by a huge competition and relevant profit margins, the launch of effective, safe and innovative drugs becomes one of the most important indicators of the success of the companies in the pharmaceutical sector. However, the achievement of success in this context is related not only with the high investments and researchers’ qualifications, but also to settle the possible regulatory issues and technical barriers inherent to this process. This study aims to analyze and demonstrate the critical points, key issues on the development of new pharmaceutical products in Brazil and how it affects society and companies in the pharmaceutical sector. This study is supported by triangulation method between the scientific and technical literature review, the perception analysis of the regulated segment investigated and the perception analysis of the regulatory agencies investigated. This work seeks to contribute to appoint the existence of adversities and challenges of this process and also to suggest possible solutions to improve the performance of pharmaceutical companies in Brazil. Although this study had verified the existence of regulatory barriers, such as regulatory approvals delays and fragile legislation, it had also identified positive aspects of this segment regarding high qualification of the professionals interviewed and investment in innovation by regulated companies

La thèse examine les configurations d'acteurs et d'organisations impliquées dans la régulation de l'accès au marché des médicaments en France et en Angleterre, en charge du contrôle scientifique et administratif de la fixation du prix et du remboursement de ces produits. Cette activité s'autonomise de l'appréciation clinique de leur qualité, de leur efficacité et de leur innocuité (dominant la régulation de leur approbation sur le marché) au cours des années 1980. / This thesis examines the configurations of actors and organizations involved in the regulation of the market access for drugs in France and England. Since the mid-1980s, this process has entailed the development of administrative and scientific controls over the fixing of the price and the conditions of reimbursement of these products. These controls have become autonomus from clinical appreciation of their quality, efficacity and safety that dominate approval regulation as a whole.

This thesis argues that corporations qua corporations are moral agents sui generis and hence capable of being held morally responsible. I argue that corporations qua corporations are responsible for the actual and foreseen consequences of their actions. I analyse normative theories and the different proscriptive responsibilities they place on moral agents and hence corporations. I examine Kantianism, utilitarianism and virtue ethics. I argue for a unique normative ethical theory that incorporates reasoning from all three of the normative theories. I argue for a broad range of reasons to factor into deciding whether an act is ethical or not. One of the claims of this thesis is that ethical theories must incorporate an agent’s motivation, intention and character traits as relevant to deciding on whether an action is ethical or not. My thesis argues for an indispensable role for the virtues while at the same time incorporating impartial beneficence and universal rationality from utilitarianism and Kantianism. This position I, following the literature, refer to as moderate virtue theory. Having established corporate qua corporate responsibility I question the pharmaceutical corporation’s practice of patenting life saving medication during a state of pandemic in poor countries. The moderate virtue theory position prioritises contexts and the actual human condition and criticises normative theories that attempt to give universal, abstracted answers to ethical problems. It is for this reason and the current (2003) HIV/AIDS pandemic that I focus on a particular context. I examine the practice of patenting life saving medication within South Africa and argue, applying moderate virtue theory, that this act cannot be justified. I argue that a pharmaceutical corporation that patents life saving medication in South Africa cannot justify that action and thus is morally responsible for that action. I also argue that corporations patenting HIV/AIDS medication in South Africa have unethical motivations and intentions.

Cette thèse vise à comprendre les freins à l’achat des médicaments génériques chez les patients-consommateurs. Plus particulièrement, notre recherche vise par le biais d’une étude qualitative et quantitative à améliorer l’efficacité des communications des acteurs de santé pour réduire le risque perçu à l’achat des génériques. Il s’agit plus précisément d’étudier les variables susceptibles d’expliquer l’attitude envers la substitution, mais aussi de comprendre les mécanismes impliqués, et de mettre en lumière les variables les plus à même à expliquer l’intention d’achat d’un médicament générique (vs princeps). Ainsi, nous avons cherché à explorer les facteurs explicatifs de la perception et de la réduction du risque envers les génériques à travers des entretiens semi-directifs individuels menés auprès de 24 patients-consommateurs. Les résultats de l’étude quantitative menée auprès de 303 personnes, soulignent que (1) le risque perçu envers la substitution et l’attitude envers les génériques médiatisent la relation entre le risque perçu envers les génériques et l’attitude envers la substitution, (2) la confiance dans la source d’informations (pharmacien et médecin) modère la relation entre l’attitude envers la substitution et l’intention d’achat d’un médicament générique (vs princeps) et (3) l’effet d’interaction entre le capital marque du médicament générique : faible (vs fort), la chronicité de la maladie : non chronique (vs chronique) et le taux de remboursement : 65% (vs 100%) sur l’intention d’achat d’un médicament générique (vs princeps) est validé. Sur un plan théorique, la recherche permet d’éclairer la littérature sur le risque perçu en matière de santé, notamment en mobilisant un concept issu de la médecine « l’effet nocebo». Les implications managériales sont multiples, tant pour les laboratoires pharmaceutiques génériqueurs, d’une part, que pour les pharmaciens, les médecins et enfin les pouvoirs publics décideurs des politiques de communication en faveur des médicaments génériques, d’autre part. / This thesis aims to understand the obstacles to the purchase of generic drugs in patients-consumers. More specifically, it aims, through a qualitative and a quantitative study, to improve the efficiency of communication of health actors to reduce the perceived risk in buying generics. More precisely, it intends to examine the variables that explain the patients-consumers attitudes towards the substitution, to understand the mechanisms involved in this process and to highlight the most likely variables that explain the intention of purchasing a generic (vs brand name) drug. Thus, we aimed to explore the factors that explain the perception and reduction of risks towards the generic drugs by conducting individual semi-structured interviews with 24 patients-consumers. The results of the quantitative study of 303 individuals point out that (1) the perceived risk towards the substitution and the attitude towards generic drugs mediate the relationship between the perceived risk towards generic drugs and attitude towards substitution, (2) the trust in the information source (pharmacist and physician) moderates the relationship between the attitude towards substitution and the intention of purchasing a generic (vs brand name) drug and (3) the interaction effect between the brand equity of generic drug : low (vs strong ), the chronicity of disease : non chronic (vs chronic) and the repayment rate : 65% (vs 100%) on the intention purchase generic (vs brand name) drug is validated. Theoretically, the research sheds light on the literature on the perceived risk in health, including mobilizing a concept from the medicine "Nocebo effect". The managerial implications are manifold for generic pharmaceutical industry as well as for pharmacists, physicians, and, finally government makers of communications policies for generic drugs.

A partir de 2002, grâce à l'introduction du concept de la Qualité par la Conception (en anglais Quality by Design : QbD) par l'agence américaine des produits alimentaires et médicamenteux, l'industrie pharmaceutique a intensifié les efforts et les investissements pour permettre une libération en temps réel des lots commerciaux. Le QbD propose que la qualité soit construite dès la conception initiale du médicament plutôt que d'être évaluée à la fin de sa fabrication. Ainsi, avec l'initiative QbD, les tests de contrôle de la qualité de médicaments, réalisés après la fabrication des comprimés, peuvent être éliminés si les paramètres qui les influencent sont contrôlés.En effet, ces tests de contrôle qualité dits traditionnels requièrent en général plusieurs heures pour leurs préparations et leurs réalisations. Tel est le cas du test de dissolution. Ce test est très consommateur de ressources matérielles et humaines. La réalisation de stratégies de contrôle pour les tests de dissolution basée sur une approche QbD pourrait être bénéfique pour l'industrie pharmaceutique.À travers ce travail, nous avons pu :• proposer différentes stratégies novatrices de contrôle du test de dissolution de comprimés pharmaceutiques sur la base des principes du QbD,• apporter un nouvel éclairage sur la compréhension des phénomènes impliqués dans la dissolution de comprimés pharmaceutiques.Les résultats de ce projet de recherche ont permis 1) la mise en évidence des paramètres critiques influençant le test de dissolution, 2) l'élaboration et l'évaluation de modèles statistiques pour les combinaisons de variation de paramètres selon un plan d'expérience préalablement conçu, 3) la corrélation du test de dissolution à des paramètres critiques de procédés de fabrication et d'attributs de matériaux grâce aux technologies d'analyse de procédés. / With the introduction in 2002 of the concept of Quality by Design (QbD) by the Food and Drug Administration, the pharmaceutical industry intensified efforts and investments to reach real time release of commercial batches, reducing time between manufacturing and availability to the patient. QbD proposes that quality should be built in the initial design of a product rather than being assessed at the end of the tablet manufacturing. Thus, with the QbD initiative, quality control tests of tablets like dissolution testing performed after tablets manufacturing could be removed if the parameters impacting them are controlled.Indeed, quality control tests such as traditional dissolution tests generally require several hours for their preparation and their realizations. Dissolution tests are very consuming of time, material, equipment and human resources. The elimination of these tests through a QbD approach could be beneficial for the pharmaceutical industry.Thanks to this work, it was possible to :• propose different innovative strategies to control the dissolution test of pharmaceutical tablets based on the principles of Quality by Design,• have a better understanding of this quality control test.The main results relies on 1) the identification of critical parameters influencing the dissolution test, 2) the development and evaluation of statistical models for the combination of variation of parameters according to an experimental design, 3) the correlation of dissolution test to critical manufacturing process parameters and attributes of materials through process analysis technology.

The thesis addresses the analysis of the marketing mix in the pharmaceutical industry with a detailed focus on the promotion and communication channels of the prescription drug. The aim is to help a company with a control and optimization of the communication strategy so that it is adapted to the new trends. The differences between the prescription drug and the over-the-counter drug in the aspects of communication, promotion and the role of branding is drawn. Several methods such as analysis, description and marketing research are used. The thesis is divided into five main chapters.

This work is focused on marketing communication in the pharmaceutical industry. The theoretical part contains a description of the pharmaceutical market, a brief analysis of the marketing mix with a detailed focus on the individual instruments of promotion (personal selling, advertising, direct marketing, public relations and sales support). It also contains partial laws, regulations, standards which are used in marketing communication. The practical part contains an analysis of marketing communication practices of selected pharmaceutical manufacturer with a focus on medicine or drug Motilium. Following analysis and comparison of different tools of communication mix together with value of the costs of activities, as well as proposed ways to improve marketing communication process and recommendation.

The aim of this thesis is to analyse the research area of omitted intangible assets from the balance sheet and consider rewards of their potential recognition in the statement of financial position. The theoretical part provides the reader with the current regulation in force and compares it to the regulation prior the standardization and convergence process. The empirical part focuses on valuation of equity of three companies from the pharmaceutical industry based on the model pursued by American professor Stephen Penman. The values obtained are subsequently compared to market prices which are believed to reflect also the possession of omitted intangible assets. Differences identified speak in favour of potential recognition, however these are believed to be marginal comparing to probable inherent risks, which include, inter alia, stock market run-ups and earnings management.