O objetivo deste trabalho foi realizar diagnóstico para solução de problemas de atraso na entrega das atividades e relatórios de pesquisa, bem como de dificuldade de se definir o objetivo e escopo do projeto, encontrados no departamento de estudos pré-clínicos e clínicos de empresa de saúde animal. Isso porque, antes dos novos produtos veterinários entrarem no mercado, estes devem passar por testes que comprovem sua eficácia e segurança, conforme exigido pelo órgão regulatório. Neste contexto, verifica-se a importância da realização de estudos clínicos conforme planejamento e prazos previamente estabelecidos, pois estes impactam diretamente nos resultados e planejamento estratégico da empresa. Para tanto, foi realizado diagnóstico dos atrasos através de avaliação de cronogramas de projetos finalizados. Como proposta de solução foi elaborado um formulário de planejamento de projetos a partir dos conceitos do PMBOK®. Este foi aplicado no início de cada novo projeto e inserido no fluxograma de processos do departamento. Para avaliação dos resultados da inserção deste formulário foram aplicados aos colaboradores do departamento questionários fechados juntamente a cada preenchimento do formulário. Os dados obtidos destes questionários foram avaliados através da análise de componentes principais. Além disso, foi realizada entrevista semiestruturada com os colaboradores para verificar efetivamente a mudança no cenário do departamento pós-formulário, sendo os dados avaliados conforme método de análise de discurso. Como resultados foi verificado que ocorreram atrasos em pelo menos 50% das atividades presentes nos 22 cronogramas de projetos avaliados, isso devido principalmente ao planejamento inadequado, de acordo com os relatos dos colaboradores. Com a aplicação do formulário e análise dos dados dos questionários e das entrevistas foi possível verificar que a utilização do formulário tem grande importância na definição dos objetivos do projeto, definição de escopo, e consequente definição das atividades indicadas para cada estudo, ou seja, auxilia no planejamento do estudo. Além disso, proporciona aos colaboradores a reflexão e visão crítica dos projetos, assim como deixa documentado tudo aquilo que foi pensado evitando retrabalhos posteriores. / The objective of this study was to perform a diagnosis to solve problems of delay in activities and research reports\' delivery, as well as the difficulty to define project\'s objective and scope, found in the pre-clinical and clinical studies department of animal health company. This happens because new veterinary products must undergo tests that prove their efficacy and safety, as required by the regulatory agencies before being marketed. In this context, it is important to carry out clinical studies according to the planning and deadlines previously established, as these have a direct impact on the results and strategic planning of the company. For this purpose, the delays were diagnosed through the evaluation of completed project schedules. As a proposal for solution, a project planning form was developed based on PMBOK® concepts. This was applied at the beginning of each new project and inserted into the department\'s process flowchart. To evaluate insertions\' results of this form a closed questionnaire was applied to employees of the department with each filling out form. The data obtained from these questionnaires were analyzed through principal components analysis. In addition, a semi-structured interview was conducted with the employees to effectively verify the change in the post-form department scenario and the data were evaluated according to the discourse analysis method. As results it was verified that there were delays in at least 50% of the activities present in the 22 schedules of evaluated projects, mainly due to inadequate planning, according to the collaborators reports. With form\'s application and data\'s analysis of questionnaires and interviews it was possible to verify that the use of the form has great importance in the definition of project\'s objectives, definition of scope and consequent activities\' definition indicated for each study. In other words, it assists in the planning of the study. In addition, it provides the employees with the reflection and critical vision of projects, as well as documenting everything that was thought avoiding subsequent rework.

Orientador: Orlando Fontes Lima Júnior / Dissertação (mestrado) - Universidade Estadual de Campinas, Faculdade de Engenharia Civil, Arquitetura e Urbanismo / Made available in DSpace on 2018-08-19T14:18:35Z (GMT). No. of bitstreams: 1 Arruda_LuizAntoniode_M.pdf: 4116724 bytes, checksum: 34f4e122a919d945ff387e1db04f6669 (MD5) Previous issue date: 2011 / Resumo: As empresas, em busca de redução de custo e melhoria da eficiência, tornam as suas cadeias de suprimentos mais globalizadas e complexas. Com isso, um evento que ocorre em uma parte do mundo pode afetar uma empresa situada do outro lado. Como consequência, o grau de exposição ao risco aumenta na mesma proporção da globalização. Assim, o gerenciamento de risco tornou-se um instrumento para as empresas identificarem, avaliarem e tratarem os riscos, permitindo tomar ações para mitigá-los. O setor farmacêutico brasileiro foi selecionado por ser um setor com uma forte cultura de qualidade e preocupação com a segurança dos seus produtos. Pois sabe das graves consequências das falhas de seus produtos. Esse trabalho tem como objetivo principal identificar a percepção da probabilidade de ocorrência de uma relação de eventos de risco e a percepção de risco na cadeia de suprimentos da indústria farmacêutica, na visão dos gestores de logística. Também identificar qual é o propósito do gerenciamento do risco na cadeia de suprimentos, quais são os princípios aceitos e/ou aplicáveis para a mitigação dos riscos e quem são os responsáveis pelo gerenciamento de risco na empresa. Utiliza-se um questionário para coletar a percepção da probabilidade de ocorrência dos eventos de risco e outro questionário para coletar a percepção de risco na cadeia de suprimentos. Também identificar qual é o propósito do gerenciamento de risco, quais são os princípios aceitos e/ou aplicáveis e quem são os responsáveis pelo gerenciamento de risco nas empresas. As respostas serão analisadas de forma geral e pelo grupo de tamanho do faturamento das empresas, usando o percentual da frequência das respostas e os resultados apresentados em gráficos e tabelas / Abstract: As companies seek to reduce costs and improve efficiency, they make their supply chain more global and complex. As a result, an event that takes place in one part of the world can adversely affect a company located elsewhere. Additionally, the degree of exposure to a risk increases at the same rate as globalization. Risk management has become a tool used by many companies to identify, assess and address risk events, and take appropriate actions to mitigate them. The Brazilian pharmaceutical industry has been selected because it is a sector with a strong quality culture and concerned with product security. This sector is aware of the severe consequences when they products fail. This study has as its purpose to identify the perception of probability of occurrence of risk events and the perception of risk in the supply chain of the pharmaceutical industry within the view of logistics managers. Also, identify which is the purpose of risk management in the supply chain and which are the acceptable and/or applicable principles to mitigate risks and who are those responsible for risk management in a company. Answers will be analyzed in general and by grouping companies by size, using the percentage of responses frequency and showing the results in graphics and tables / Mestrado / Transportes / Mestre em Engenharia Civil

Submitted by Marcia Silva (marcia@latec.uff.br) on 2015-11-19T14:37:53Z No. of bitstreams: 1 DISSERTAÇÃO ADÉLIA VIVIANE DE LUNA.pdf: 1300839 bytes, checksum: 57ef96d77a59870b10798fc7e7d3f0bc (MD5) / Made available in DSpace on 2015-11-19T14:37:53Z (GMT). No. of bitstreams: 1 DISSERTAÇÃO ADÉLIA VIVIANE DE LUNA.pdf: 1300839 bytes, checksum: 57ef96d77a59870b10798fc7e7d3f0bc (MD5) Previous issue date: 2013-08-14 / Esta pesquisa tem como objetivo analisar o processo produtivo da linha de medicamentos sólidos orais - comprimidos revestidos, utilizando as ferramentas da qualidade. A metodologia proposta consiste em uma série de passos de sequência lógica que permitirá analisar, identificar e propor soluções para os desvios da qualidade. A MAMP e MASP propostas serviram para iniciar o processo de levantamento dos dados produtivos. Ao longo do trabalho foram verificadas quais ferramentas da qualidade mais se aplicam nas etapas do processo e à política da empresa, lembrando que por tratar-se de uma indústria pública alguns fatores devem ser levados em consideração. Foi realizada uma aplicação prática da metodologia junto aos colaboradores ligados diretamente ao processo a fim de mensurar a aceitabilidade dos métodos e dos planos de ações de melhoria propostos. Espera-se então que esse processo produtivo venha a ser mais eficiente e eficaz e que as perdas, desperdícios e custos com retrabalhos sejam diminuídos. / This research aims to analyze the production process of solid oral medication line - dry- coated tablets, using the tools of quality. The proposed methodology consists of a series of logical steps that will analyze, identify and propose solutions to the quality deviations. The MAMP and MASP proposals served to begin the process of data collection productive. Throughout the work were checked more qualities which tools apply the steps of the process and the politics of the company, always remembered that because it is a public industry factors must be taken into consideration. Was performed a practical application of the methodology with employees directly related to the process in order to measure the acceptability of methods and plans for improvement actions proposed. It is hoped then that this production process will be more efficient and effective, losses, scrap and rework costs are decreased

[pt] Contribuindo para o desenvolvimento da confiabilidade metrológica, a presente dissertação de mestrado propõe um modelo integrado de gestão dos padrões metrológicos de referência utilizados na fabricação de medicamentos. Em sintonia às práticas laboratoriais e normas internacionais, o modelo proposto também incorpora o monitoramento de desempenho desses padrões e de instrumentos de processo utilizado entre calibrações sucessivas. O trabalho respalda-se em pesquisa relacionada às práticas correntes de gestão laboratorial conduzida junto a tradicionais laboratórios de calibração de instrumentos de processo da indústria farmacêutica. No contexto de distintas vertentes de análise, o modelo proposto incorpora os seguintes atributos considerados essenciais (i) gestão de padrões metrológicos; (ii) avaliação da relevância da instrumentação de processo para a qualidade; (iii) gestão para tratamento de não- conformidades; (iv) gestão da freqüência de calibração dos instrumentos de processo; (v) gestão da calibração na fabricação e (vi) gestão da calibração na validação de processos críticos de fabricação de medicamentos. A referida pesquisa realizada junto a esse setor de fabricação de medicamentos envolveu 36 laboratórios selecionados dentre aqueles com comprovada experiência e tradição no setor, localizados nos Estados do Rio de Janeiro e de São Paulo, pólo industrial onde se concentram expressiva produção nacional de medicamentos (cerca de 70%). Cada uma das linhas de análise relacionadas aos seis atributos de gestão laboratorial acima mencionados fundamenta-se nos critérios de avaliação: qualidade, produtividade e confiabilidade metrológica. / [en] The development of metrological reliability has received in recent years increasingly attention from metrologists. Confidence in measurements is a prerequisite in the manufacturing of pharmaceutical products The present Master`s Dissertation formulates an integrated managerial model for dealing with metrological reference measuring standards (étalons) used in the pharmaceutical sector. In full compliance with international standards and best laboratory practices, the proposed model incorporates the monitoring of performance of standards and instruments used during two successive calibrations. The work is based on a search related to the best current laboratorial practices developed in connection with laboratorial management in their relation with traditional calibration labs of process instruments operating in the pharmaceutical industry. In this context, the proposed model incorporates the following lines of analysis considered as essential ingredients in the proposed metrological reliability approach: (i) management of metrological standards; (ii) evaluation of the relevance of the process instrumentation for quality control; (iii) management for non-conformity treatment; (iv) management of the frequency of calibration of the process instruments; (v) management of the calibration in the manufacturing process and (vi) management of the calibration in the validation of the critical processes of the pharmaceutical industry. 36 among the most traditional pharmaceutical labs located in the states of Rio de Janeiro and São Paulo - responsible for nearly 70% of all pharmaceutical products in the country - were selected for the survey. For the sake of metrological analyses, each one of the 6 requisites listed above, was based on assessment criteria which included quality, productivity and metrological reliability.

info:eu-repo/semantics/nonPublished

University of Macau / Institute of Chinese Medical Sciences

Chapter 1: Patents and Entry Competition in the Pharmaceutical Industry: The Role of Marketing Exclusivity Effective patent length for innovation drugs is severely curtailed because of extensive efficacy and safety tests required for FDA approval, raising concern over adequacy of incentives for new drug development. The Hatch-Waxman Act extends patent length for new drugs by five years, but also promotes generic entry by simplifying approval procedures and granting 180-day marketing exclusivity to a first generic entrant before the patent expires. In this paper we present a dynamic model to examine the effect of marketing exclusivity. We find that marketing exclusivity may be redundant and its removal may increase generic firms' profits and social welfare. Chapter 2: Why Authorized Generics?: Theoretical and Empirical Investigations Facing generic competition, the brand-name companies some-times launch generic versions themselves called authorized generics. This practice is puzzling. If it is cannibalization, it cannot be profitable. If it is divisionalization, it should be practiced always instead of sometimes. I explain this phenomenon in terms of switching costs in a model in which the incumbent first develops a customer base to ready itself against generic competition later. I show that only sufficiently low switching costs or large market size justifies launch of AGs. I then use prescription drug data to test those results and find support. Chapter 3: The Merger Paradox and R&D Oligopoly theory says that merger is unprofitable, unless a majority of firms in industry merge. Here, we introduce R&D opportunities to resolve this so-called merger paradox. We have three results. First, when there is one R&D firm, that firm can profitably merge with any number of non-R&D firms. Second, with multiple R&D firms and multiple non-R&D firms, all R&D firms can profitably merge. Third, with two R&D firms and two non-R&D firms, each R&D firms prefer to merge with a non-R&D firm. With three or more than non-R&D firms, however, the R&D firms prefer to merge with each other.

In the past few decades, there has been increasing concern towards the potential effects of industrial pollutants on our eco-system. Each country has developed and enacted stringent environmental regulatory standards to address this concern. Several studies conducted in the general area of regulatory impact show significant direct impact of these regulations on organizations. Pharmaceutical industry in particular, due to the generation of variety of hazardous waste during operations, is one among the highly regulated industrial sector globally. The financial liabilities and resource shortages associated while incorporating abatement technologies and related procedural changes make Pharmaceutical Small and Medium Enterprises (PSMEs) highly vulnerable to these regulatory compliance standards. This study aims to investigate two aspects of environment regulation compliance in the PSMEs, namely To identify the nature and magnitude of vulnerabilities encountered by the PSMEs in India while complying with environmental regulations, and To explore and to analyze the adaptation mechanisms followed by the PSMEs in India, while complying with environmental regulations. Literature explorations in the area of environmental regulation, enforcement, compliance, pharmaceutical industry and SMEs, gave limited studies with focus on India. Hence a questionnaire based survey was administered online and face to face. The sampling design followed was stratified random and the total sample size taken for the final analysis was 71. The survey targeted the senior executive officers of pharmaceutical firms across India. Unstructured discussions and interactions with experts in the field were also carried out to understand the gravity of each concern. Data was analyzed using the Analytic Hierarchy Process (AHP) for exploring and prioritizing vulnerability concerns, factor analysis for identifying the general adaptation mechanisms and systems practiced, and cluster analysis for assessing the underlying relationship among vulnerability concerns and adaptation patterns of firms under study. Findings of the analysis highlighted several significant drivers of the interaction between the PSMEs and the environment regulations. Some of them are as follows: One, conforming to literature finding, our study also found manufacturing related problems as the most significant concern for the PSMEs. However, unlike the Western countries, it was the poor quality of raw material available in the market that causes the main concern, and not the need for intensive capital investment in abatement technologies. Investigations revealed the steady global market decline for this sub-sector and the need for new innovations to meet the changing global trends. Two, marketing was a significantly higher concern for the PSMEs than regulator and regulatory management. Marketing has special relevance in the pharmaceutical industry as it deals with health and life saving issues for the people, and this got highlighted in our results. Three, the study found external management factors as the most followed coping / adaptation mechanism pursued by the PSMEs. Conforming to literature findings, our study also demonstrated smaller firms as significantly more vulnerable to adaptation in comparison with medium scale firms. The study also highlighted the attempt at balancing the local and global by the Indian PSMEs. While the process orientation was towards meeting international standards, the management of resources, marketing and regulatory requirements had a focus on the local pressures. The study provides some insight into the vulnerabilities and adaptation efforts of the Indian PSMEs and brings out the relevant strategic interventions needed from government, regulatory organizations and industry associations to develop a more sustainable business environment for the Indian PSMEs.

The first chapter describes a development of the pharmaceutical industry and its market. The attention is especially paid to the pharmaceutical industry of France which is considered to be a representative of the European pharmaceutical industry. The second chapter is focused on the pharmaceutical company marketing and a medicament regarded as a product and presented from its creation to a distribution to a final consumer.

Thesis is focused on drug system development in Czech Republic during years 2000 to 2008, on study of present circumstances and on key features comparison with its development in selected European countries. Author has described drug system functioning, its participants and relations among them set to Czech Republic. Attention is paid especially to sources of rise in prices of drugs and to growth in consumption, then to safety and awareness of current medication. Factors effecting total expenses on drugs are investigated and participation of total expenses on drugs on total health expenses is analyzed. Due to the international comparison there is pronounced conviction that the increase in drug expenses has become a global phenomenon of todays which is to be solved. Great emphasis is placed on questionable segments of drug policy in Czech Republic and on potentials of its improvements in this performance, too.