Made available in DSpace on 2016-03-15T19:30:54Z (GMT). No. of bitstreams: 1 Antonio Carlos Lima Nogueira.pdf: 1016857 bytes, checksum: d0156e79e588ea5faeb3dde3eeb37ad4 (MD5) Previous issue date: 2012-08-30 / Fundo Mackenzie de Pesquisa / The study aimed to analyze the influence of transaction costs and capabilities on vertical integration for the manufacturing step in the pharmaceutical sector in Brazil. This objective resulted from the potential contribution to the ongoing research agenda on the relationship between the approaches of transaction costs and capabilities. The universe of research is the total number of drugs registered at the National Agency of Sanitary Surveillance (ANVISA), which is the federal regulator or drugs in Brazil. The population is the subset of drugs available in the public database Bulário Eletrônico and the levels of analysis are the constructs of vertical integration, experience, diversification, asset specificity and bargaining power. The unit of analysis is the transaction of drug manufacturing and the object of analysis is the registry of the drug. I developed and proposed a structural model composed of a set of hypotheses with causal relationships between constructs. The model includes first order latent variables and measurable indicators based on data available on database and in the websites of the companies. With these definitions, I collected the data for each drug, including pharmaceutical form, therapeutic class, regulatory category and vertical integration of the manufacturing transaction. To test the hypotheses I conducted a confirmatory factor analysis of the measurement model through a structural equation model solved by Partial Least Squares. The first theoretical implication of the results is the identification of significant relationships between constructs related to transaction costs (asset specificity and bargaining power) and capabilities (experience and diversification) as well as relations between vertical integration and the other constructs. The second implication is the positive relationship between diversification and vertical integration. As diversification is an indicator of capabilities, the result implies that the limits of the firm reflect a bundle of capabilities expressed by processes and routines. The result could be subject to criticism that the vertical integration adoption may be resultant of cost considerations and delimitation of the scope based on the stages of greatest value to the company. The third implication is the existence of a negative relationship between asset specificity and vertical integration. The result seems to indicate the low strategic value of the manufacturing transaction in the value chain in the pharmaceutical industry. It seems that companies tend to outsource manufacturing transaction precisely for products with specific attributes. The fourth implication is the lack of influence of bargaining power on vertical integration. This result may be due to two aspects: the first is the very structure of the market portrayed by population and second is the low importance of transaction registration to generate value. In this population, the market is competitive for the more widespread forms and classes and more concentrated for products with rarer forms and classes. On the other hand, the low relevance of the transaction as a strategic activity can make decisions on vertical integration does not take into account the bargaining power of the company. / O estudo teve por objetivo analisar a influência dos custos de transação e capacitações sobre a integração vertical para a etapa de manufatura do setor farmacêutico do Brasil. O estudo justifica-se pela contribuição com a agenda de pesquisa sobre as relações entre as abordagens de custos de transação e de capacitações. O universo considerado é o total de medicamentos registrados na Agência Nacional de Vigilância Sanitária (ANVISA). A população é o subconjunto de medicamentos disponíveis no banco de dados denominado Bulário Eletrônico. Os níveis de análise são construtos de integração vertical, experiência, diversificação, especificidade de ativos e poder de barganha. A unidade de análise é a transação de fabricação de medicamentos e o objeto de análise é o registro do medicamento. Foi elaborado um modelo estrutural com um conjunto de hipóteses para as relações causais entre os construtos citados, elaboradas com base na teoria existente. A partir do modelo, foram definidas variáveis latentes de primeira ordem e indicadores mensuráveis com base nos dados disponíveis no Bulário Eletrônico e nos sítios das empresas na Internet. Com essas definições, os dados foram coletados para cada medicamento, com indicadores de forma farmacêutica, classe terapêutica, categoria regulatória e integração vertical da transação de fabricação. Para o teste das hipóteses foi realizada análise fatorial confirmatória do modelo de mensuração por meio de um modelo de equações estruturais resolvido pelo método Partial Least Squares. Quatro implicações teóricas principais do estudo podem ser destacadas. A primeira é a identificação de relações significantes entre construtos relacionados a custos de transação (especificidade de ativos e poder de barganha) e capacitações (experiência e diversificação), assim como relações entre a integração vertical e os demais construtos. Este resultado ratifica a proposta do modelo teórico de Jacobides e Winter, sobre a coevolução de custos de transações e distribuição de capacitações de empresas no mesmo sistema produtivo, com impactos no escopo vertical das empresas na cadeia de valor. A segunda implicação do trabalho se refere à relação positiva entre diversificação e integração vertical. Como a diversificação é um indicador de capacitações, o resultado indica que os limites da firma refletem um conjunto de capacitações expressas por meio de processos e rotinas. O resultado está sujeito à critica de que no estágio atual do setor farmacêutico, a adoção da integração vertical pode ser decorrente de considerações de custos e delimitação do escopo aos estágios de maior valor para a empresa. A terceira implicação é a existência de uma relação negativa entre a especificidade de ativos e integração vertical. O resultado parece indicar o baixo valor estratégico da transação de fabricação de medicamentos na cadeia de valor do setor farmacêutico. Parece que as empresas tendem a terceirizar a transação de fabricação justamente dos produtos com formas que apresentam atributos específicos. A quarta implicação é a ausência de influência do poder de barganha sobre a integração vertical no setor farmacêutico, que pode ser decorrente de dois aspectos: o primeiro é a própria estrutura de mercado retratada pela população e o segundo é a baixa relevância da transação de fabricação para a geração de valor. Nesta população, o mercado é competitivo para as formas e classes mais disseminadas e mais concentrado para os produtos com formas e classes mais raros. Por outro lado, a baixa relevância da transação como atividade estratégica pode fazer com que as decisões sobre a integração vertical não levem em conta o poder de barganha da empresa.

Made available in DSpace on 2016-03-15T19:31:13Z (GMT). No. of bitstreams: 1 Leila Rocha Pellegrino.pdf: 927284 bytes, checksum: f9fbc9c94a817e05c4d56c9063fdff32 (MD5) Previous issue date: 2015-11-17 / This study aims to explore the relationship between the constructs Relational Capacity, Diversity and Performance Alliances Portfolio, considering the unit busisness level in the Brazilian Pharmaceutical Industry. The diversity of the portfolio of contractual strategic alliances is controversial subject in the literature. The main theoretical contribution of this work is the finding that the diversity of the portfolio does not impact directly on the performance of the portfolio of contractual strategic alliances. Thus, only in the presence of the portfolio management capacity, the benefits of setting up a diversified portfolio may be perceived by the organization. Another contribution of this work was to propose a multidimensional scale of diversity.The universe considered were the companies operating in the Brazilian pharmaceutical industry. The sample was composed by companies operating in São Paulo, Minas Gerais, Santa Catarina, Ceará, Pernambuco and Rio de Janeiro. The level of analysis were the portfolios of contractual strategic alliances formed by companies in the sector. From the sample, latent variables of first and second order are defined and measurable indicators. Data were collected through structured interviews conducted with managers or persons directly linked to the process of management of organization's strategic aliances portfolio. To test the measurement model proceeded to the analysis of structural equation modeling resolved by Partial Least Square Method. / Este estudo tem como principal objetivo explorar a relação entre os construtos Capacidade Relacional, Diversidade e Desempenho da Carteira de Alianças, considerando-se o nível de unidade de negócios na Indústria Farmacêutica Brasileira. A diversidade da carteira de alianças estratégicas contratuais é objeto controverso na literatura. A principal contribuição teórica deste trabalho está na constatação de que a diversidade da carteira não impacta diretamente sobre o desempenho da carteira de alianças estratégicas contratuais. Assim, somente na presença da capacidade relacional de gestão da carteira, os benefícios da constituição de uma carteira diversificada poderão ser percebidos pela organização. Outra contribuição do trabalho, de natureza metodológica, foi a proposição de uma escala multidimensional de diversidade. O universo considerado foram as empresas atuantes no setor farmacêutico brasileiro. A amostra foi composta por empresas atuantes em São Paulo, Minas Gerais, Santa Catarina, Ceará, Pernambuco e Rio de Janeiro. O nível de análise foram as carteiras de alianças estratégicas contratuais constituídas pelas empresas do setor. Os dados foram coletados por meio de entrevistas estruturadas realizadas com gestores ou pessoas diretamente ligadas ao processo de gestão da carteira de alianças estratégicas contratuais da organização. Para testar o modelo de mensuração procedeu-se à análise da modelagem de equações estruturais resolvido pelo método Partial Least Square.

Orientadores: Sergio Robles Reis de Queiroz, Maria da Graça Derengowski Fonseca / Tese (doutorado) - Universidade Estadual de Campinas, Instituto de Geociencias / Made available in DSpace on 2018-08-04T05:28:41Z (GMT). No. of bitstreams: 1 Vieira_VeraMariadaMotta_D.pdf: 8655703 bytes, checksum: ebf225afb7dd4bd1ec639d20a21132e6 (MD5) Previous issue date: 2005 / Resumo: A inovação em produtos e processos é reconhecida como fundamental para a competitividade das empresas e dos países e parece depender de um conjunto de fatores que vão além da capacidade tecnológica (ou mudança técnica). Utilizando-se como referência teorias e estruturas analíticas recentes da literatura sobre o desenvolvimento e acumulação de competências e processos de aprendizagem, investiga-se as competências para inovar na indústria farmacêutica, especialmente as competências tecnológicas, organizacionais, relacionais, dos meios e produtivas. Tomando como modelo o "ciclo do medicamento inovador" através da rota de síntese química, analisam-se as competências envolvidas no processo de trazer à comercialização um novo medicamento. Descrevem-se os estágios tecnológicos, a cadeia produtiva, a curva de valor e a evolução das tecnologias na experimentação farmacêutica, assim como as principais transformações que vêm ocorrendo nesta indústria na atualidade e no contexto internacional e nacional. Tal referencial é aplicado ao estudo de caso da Fundação Oswaldo Cruz Fiocruz, a maior instituição de C&T em saúde da América Latina e de seu Instituto de Tecnologia em Fánnacos - Far-Manguinhos, laboratório produtor integrante da rede oficial e o único ligado ao Ministério da Saúde do Brasil. Como resultado da pesquisa, identifica-se a trajetória institucional e tecnológica da Fiocruz em medicamentos e o salto gerencial e tecnológico de Far-Manguinhos, realizado em pouco mais de duas décadas. O aprendizado tecnológico realizado através de engenharia reversa de anti-retrovirais (cópia) proporcionou ao Ministério da Saúde de promover maior acesso aos medicamentos à população através de Programas Estratégicos de Saúde Pública, como o da AIDS, trazendo economias substanciais de divisas e maior efetividade no combate às doenças no País. Constatou-se estarem instaladas na Fiocruz grande parte das competências para inovar, mas estas não estão integradas a ponto de fazer emergir uma inovação radical (fármaco ou medicamento inovador) / Abstract: Product and process innovation is acknowledged as crucial for the competitiveness of countries and firms and seems to depend on a conjunction of factors that go far beyond the stricttechnologica1 capabi1ity (or technical change). This study has as its purpose to understand and describe the competencies that are essential to arrive at innovation in the pharmaceutical industry - specially technological, organizational, relational, productive and of means - having as a basic framework analytical structures that were recent1y developed in the literature as to the development and accumulation of competences and learning processes. In trying to ana1yze the competencies necessary 50 that a new chemical entity and a new drug reaches the market one has used a model that could be called "new drug discovery, development and commercialization cycle" as well as the chemical synthesis route. In so doing, one has described technological steps or stages, the chain of production, the value curve and the evolution of the technologies in pharmaceutical experimentation, as well as the main changes that have been occurring in this industry nowadays. The thesis studies the case of Fundação Oswaldo Cruz - Brasil (Oswaldo Cruz Foundation-Brazil), an institution devoted to Science and Technology in Hea1th that is sui generis in the Brazilian pharmaceutical environment and of its re1atedPharmaceutica1 Technology Institute- Far-Manguinhos, a public laboratory that fabricates drugs as a member of the official network (the on1y laboratory with this status) of the Ministry of Health in Brazil. As a result of the study, one describes the technological and institutional trajectory of Far-Manguinhos and a1so how the institution has arrive data technologica1 and managerial leapfrogging -in over little more than two decades. This technological learning process was made through the process of reversa1 engineering (a copy) of anti-retrovirals - thus giving conditions to the Ministry of Health to promote strong access of the . population to essential medicines (specific strategic programs of public hea1th, such as that of AIDS, stay as an important example) and thus saving substantial foreign reserves and guaranteeing effectiveness to the fight against disease in Brazil. One has arrived at the conc1usion that at Fiocruz one can identify the most part of needed competencies to innovate but one could also see that such competencies are not particularly integrated to the point of making emerge aradica1 innovation (farmaco or innovative drug) / Doutorado / Politica Cientifica e Tecnologica / Doutor em Política Científica e Tecnológica

[pt] O objetivo deste estudo é o de comparar o desempenho do paradigma SCP (Mason, 1939; Bain, 1956, 1968), e de Porter (1980) na indústria farmacêutica brasileira no período de 1999 a 2002. Não se pretende, portanto, analisar a aplicabilidade ou robustez destes modelos ou mesmo criticá-los, mas tão somente testar sua aderência à realidade brasileira. Para a pesquisa, foram consideradas as 50 empresas da indústria farmacêutica brasileira com maior faturamento em reais no ano de 2002, representando 91% do faturamento total e 90% das unidades vendidas. Os dados foram retirados de Cohen (2004) e têm como fonte a base de dados do Pharmaceutical Market Brazil- PMB. Com base na técnica estatística de Modelo de Equações Estruturais e nos passos descritos por Hair et al (1998) para sua aplicação, testaram-se as variáveis selecionadas, determinaram-se as cargas em cada um dos modelos por meio da utilização do LISREL e, por fim, compararam-se os resultados apurados para os dois modelos teóricos. Concluiu-se, reservadamente, a despeito da qualidade da amostra, de pequena quantidade de casos, e do número de variáveis usadas para medir os construtos, que as estratégias das empresas têm influência mais importante no desempenho que o ambiente, confirmando estudos anteriores, e que esta influência é igual nos dois modelos testados. Uma sugestão para melhoria dos resultados diz respeito à troca da amostra pelo universo dos laboratórios, o que aumentaria a possibilidade de aderência dos modelos, sem que isso, necessariamente, venha a implicar relação direta com técnicas gerenciais. Outra, sem dúvida, seria a manutenção da amostra, mas com reavaliação das variáveis de teste. / [en] This study aims at comparing the performance of SCP (Mason, 1939; Bain, 1956, 1968) and Porter´s (1980) models in the Brazilian pharmaceutical industry between 1999 and 2002. The intension is not, therefore, to analyze the applicability or robustness of these models or even to criticize them, but just to test its adherence to the Brazilian reality. For the research, the 50 companies with greater revenue in reais in the year of 2002, in the pharmaceutical industry, are considered. They represent 91% of the total industry revenue and 90% of the industry sold units. Data are collected after Cohen (2004), which source is the Pharmaceutical Market Brazil-PMB data base. Based on the statistical technique of Structural Equations Model - SEM and using the stages described by Hair et al (1998) for its application, the selected variables are tested, the models are designed and calculated by means of LISREL and, at the end, results are compared. The conclusion, with reserves, is that, despite the quality of the sample - having small number of cases and proporcional great number of variables used to measure the constructs - the companies strategies show greater influence on the performance than the industrial structure, confirming previous studies, and that this influence is same in the two tested models. A suggestion for the improvement of the results concerns changing the used sample for the universe of the laboratories, what would increase the possibility of adherence of the models, without implicating direct relationship with managerial techniques. Other sugestion is to maintain the sample, but with revaluation of the test variables.

1 ABSTRACT SPECIFIC OF PATENT LAW IN PHARMACEUTICAL INDUSTRY This thesis scopes on particularities of patent law with regard to pharmaceuticals. It describes the basics of patent law while focusing mainly on international treaties, in particular on systems established by EPC and TRIPS. The patent system in USA and in the Czech Republic is also noted. This thesis is divided into seven chapters. In the first chapter named sources of law international institutions, treaties and situation in European union, USA and Czech Republic are described here. This chapter also deals with basic legal instruments such as patent, corporate invention or utility model. The next chapter is focused on individual conditions that need to be met in order to grant a certain patent - the most basic are novelty, inventive step and industrial applicability. The following chapter deals with problems associated with costly development of new drugs and the need of companies to get the longest possible protection for their inventions. A special chapter addresses exceptions to the stiff patent regulation. Described in the next chapter is the compulsory license, a legal instrument not very particular in the Czech Republic but relevant in some developing countries used in order to secure better availability of drugs to society. Other...

The purpose of this thesis is valuation of the Zentiva, k.s. enterprise. The value of this enterprise will be determined as of 1.1. 2014, using the discounted free cash flows valuation method. This thesis is divided into a theoretical and a practical section. The theoretical section acquaints readers with the key terms and methods used during valuation. The theoretical section includes a chapter about the pharmaceutical industry and will familiarise readers with current factors influencing this sector, such as price regulation in the field of medicaments, demographic development, life style and others, which have significant impact on determining the company's final value. The practical section consists of a description of Zentiva, k.s., a strategic analysis, financial analysis, execution of a financial plan and, finally, actual valuation. The result of this thesis is valuation of the enterprise, taking into account socio- economic factors to determine its final value.

Bakgrund: Outsourcing är inget nytt fenomen då transaktionskostnadsteorin formades 1937 som beskrev att företag bör vända sig till marknaden i de fall detta gynnade företaget ekonomiskt. Sedan dess har teorier kring outsourcing förändrats och i dag handlar outsourcing om att kunna fokusera på företagets kärnkompetens och vilka möjligheter och risker outsourcing medför. Läkemedelsbranschen har på senare år börjat outsourca forskning och produktutveckling, vilka ses som kärnprocesser. Det råder därför delade meningar om branschen faktiskt har en kärnprocess. Syfte: Syftet med denna uppsats är att förstå hur och varför läkemedelstillverkningsbranschen outsourcar, om de outsourcade processerna har koppling till företags kärnprocesser och hur outsourcing faktiskt påverkar företaget, både monetärt och icke-monetärt. Metod: Det empiriska materialet insamlades med både kvantitativ och kvalitativ metod. En enkätundersökning genomfördes för att få en generell bild av hur läkemedelstillverkningsbranschen outsourcar för att sedan genomföra tre intervjuer för att få djupare kunskap om varför företag gjort de angivna val kring outsourcing. De intervjuade företagen valdes ut genom ett typiskt urval där företag valdes som svarat utifrån vissa bestämda kriterier. Slutsats: Uppsatsen har belyst att den vanligaste processen att outsourca är tillverkning, men att även forskning och produktutveckling outsourcas till viss del. Detta berodde på att företag upplevde resurs- och kunskapsbrist inom de outsourcade processerna. Studien fann även att sambandet mellan anledningen till och utfallet av outsourcing var svagt. Däremot hamnade den ökade lönsamheten sist inom båda kategorierna. Det påvisades också att det är svårt att definiera en kärnprocess till branschen med anledning av den diversifiering som i dag karaktäriserar branschen. Däremot framkom produktutveckling som den vanligaste kärnprocessen inom företag, där det visade sig att företag inte tenderar att outsourca sin kärnprocess. / Background: Outsourcing is not a new phenomenon. Transaction cost theory was formed in 1937, which described that companies should transfer activities externally when this benefited companies financially. Since then, theories of outsourcing have changed and today, it has been switched to outsourcing of core competencies and a discussion of both opportunities and risks. In recent years the pharmaceutical industry has started to outsource their research and product development, which is considered a core process. Due to this there is a debate whether or not the industry has a core process. Purpose: The purposes of this thesis are to understand how and why the pharmaceutical manufacturing industry is outsourcing, how the outsourced processes relate to their core processes and how outsourcing affects the companies, both monetary and non-monetary. Method: The empirical evidence was gathered with both quantitative and qualitative methods. Firstly, a survey was conducted to get a general picture of how the pharmaceutical manufacturing industry outsources which was then followed by three interviews to gain an in-depth knowledge of why companies have made specified decisions regarding outsourcing. The companies were selected according to a number of specific criteria. Conclusion: The thesis has highlighted that manufacturing is the most common process of outsourcing, but also that research and product development is outsourced to some extent. This was due to the fact that companies experienced resource and knowledge shortage in the outsourced processes. The study also found that the relation between the reason and the outcome of outsourcing was weak. However, the increased profitability ended last in both categories. It was also found that it is difficult to define a core process within the industry due to the diversification that today characterizes the industry. On the other hand, product development appear to be the most common core process within companies, where it also shows that companies tend not to outsource their core process.

The pharmaceutical industry must worry about managing pharmaceutical waste as it poses a health risk to human beings and its presence in the environment can also contribute to loss of biodiversity. Ngwuluka, Ochekpe, and Odumosu (2011: 11259) state that “Pharmaceuticals, though used to treat and manage diseases, are poisons, which justify the growing concerns about their presence in the environment.” Various forms of pharmaceutical waste exist, Ngwuluka et al. (2011) identified the following forms of pharmaceutical waste: Expired dosage forms, non-reworkable formulations, spilled pharmaceuticals, rejected active pharmaceutical ingredients, expired active pharmaceutical ingredients, and wastewater resulting from the water used for process operations during manufacturing and could come from the water used to clean equipment, pipes and floors, and would contain amongst other materials, chemicals and active pharmaceutical ingredients (APIs). A review on the pharmaceutical industry and the progress they have made in environmental management by generating health, safety and environmental programs, preventing pollution, waste minimization, recycling and reusing materials, investing in projects and facilities to ensure environmental sustainability have been established (Berry & Rondinelli, 2000). Dr. Reddy’s Laboratories is an Indian based pharmaceutical company which imports, markets and sells medicines in South Africa. Dr. Reddy’s has plans to set up a manufacturing plant in South Africa. The purpose of this study is to research waste management practices at Dr. Reddy’s plant in India and to draw parallels between India’s and South Africa’s waste legislation. This is to enable Dr. Reddy’s to review all aspects of its waste management systems, in order to revise where necessary and to improve the overall achievement of its waste management objectives in order to become a more sustainable organisation and to meet South African Waste legislation before setting up a plant in South Africa. 3 ii. Objective of the Evaluation Report The purpose of this research is to evaluate and analyse the development and implementation of a waste management system in a pharmaceutical company, specifically Dr. Reddy’s Laboratories. This is primarily to enable the company to review and analyse all aspects of waste management pertaining to pharmaceutical manufacturing and to revise or improve where necessary to ensure adherence to waste regulations as outlined by government. The following research goals have been also been identified:  To identify and describe waste management practices at Dr. Reddy’s Laboratories, on the inherent assumption by the researcher that the company has a successful waste management strategy that would need to be reviewed to identify areas of improvement before expanding manufacturing facilities into South Africa.  To evaluate, assess and compare similarities and/or differences between the identified South African Legislation for Waste Management with those identified during research conducted at Dr. Reddy’s iii. Importance of the Research Conducted Waste Management is important in that it not only removes from the environment, substances that can be harmful to humans and animals but it also enables an organisation to be more sustainable. According to Seadon (2010: i) “Integrated waste management is considered from a systems’ approach, with a particular emphasis on advancing sustainability”. The study will provide guidance to senior management, shop floor managers and employees who work in Dr. Reddy’s manufacturing plants as well as overall employees at Dr. Reddy’s on how to successfully implement a Waste Management programme to enhance sustainability at the organisation and realise the benefits to the organisation of being more sustainable. Weybrecht (2010) identified the following benefits that companies could gain by adopting sustainable waste management practices: reduced costs, resource preservation, keeping up with legislation, enhanced reputation, business differentiation from competitors, and attraction and retention of quality employees, and customer need satisfaction amongst many other benefits. This research needs to address the gap in analysing waste management practices (with more emphasis on waste treatment, waste minimisation, re-use, recycling and disposal), and implementation and understanding of waste management in the pharmaceutical industry as prior research was done mostly in other chemical industries and not to a large scale in the pharmaceutical industry. South African Waste Legislation, Indian Waste Legislation (as Dr. Reddy’s is based in India), as well as International Pharmaceutical Waste Management Guidelines, and International Pharmaceutical Good Manufacturing Practices provide a framework and benchmark of leading pharmaceutical waste management practices that can guide Dr. Reddy’s Laboratories’ leadership into integrating their waste management practices into their plans of setting up a manufacturing plant in South Africa. 5. Research Methodology This is evaluation research in the form of a case study and the data collection method employed is the conduction of a survey through questionnaires. The evaluation research also involves a document analysis of the organisation’s 2011 and 2012 annual reports, Dr. Reddy’s 2010 Sustainability Report as well as literature compiled by the organisation’s Corporate Communications Division. The research would also include review of existing literature on waste management. v. Structure of Dissertation This dissertation consists of three sections. Section 1: The Evaluation Report The section introduces the research area, provides the objectives of the research, provides contextual background information and describes the rationale for conducting the research. This section further describes Dr. Reddy’s waste management practice as outlined in relevant company documentation; it is also intended to highlight the specific waste management processes that were followed in the formulation and implementation of the waste management strategy. This section further describes the sample and presents the results of the survey, where the results are collated and reviewed in the context of the criteria set in the South African Waste Legislation, Indian Waste Legislation, as well as in International Pharmaceutical Waste Management Guidelines, and International Pharmaceutical Good Manufacturing Practices. The overall findings of this case study suggest that although management at Dr. Reddy’s are satisfied with waste management practices and results achieved at it manufacturing plant, there is however dissatisfaction amongst employees who believe the organisation has not successfully disseminated information and sufficiently trained them on waste management policies, processes and practices. There is therefore a desire amongst employees to be trained and to see the company improve on its waste management processes, this desire is a very important attribute as it indicates that employees at Dr. Reddy understand and are committed to the importance of waste management. Future research should be conducted to measure the legal impact of non-compliance to legislation governing waste management in the pharmaceutical company. Section 2: Literature Review The objective of the literature review is to provide a critical assessment and evaluation of previous research in the field of waste management in general as prior research was done mostly in other industries and not to a large scale in the pharmaceutical industry. The literature review evaluates the key elements of an effective waste management strategy implementation and is followed by a review of literature pertaining to the description of Pharmaceutical waste. Section 3: Research Methodology This section presents a description of how the work in this research was conducted. It presents the research process followed in compiling this case study, represented by the aims and objectives, research methodology and design, data collection techniques and data analysis.

Evaluation of marketing communication selected from the group of pharmaceutical products, OTC drugs intended for treatment of flu and colds by a questionnaire survey focused on specific factors influencing consumer behavior of the target group of customers

L'industrie pharmaceutique vétérinaire doit satisfaire de nombreux besoins spécifiques à la grande diversité des espèces et des maladies animales, afin de répondre à la forte demande d'innovation, ainsi qu'au maintien sur le marché des "vieux" médicaments vétérinaires déjà autorisés. Le médicament vétérinaire fait l'objet d'une évaluation scientifique destinée à garantir sa qualité, son efficacité et sa sécurité. Les risques liés à son utilisation pour l'animal, mais aussi et surtout pour l'homme en tant qu'utilisateur dudit médicament et consommateur de denrées alimentaires d'origine animale, et pour l'environnement, ont conduit à un accroissement progressif et constant des exigences réglementaires. Le manque de médicaments vétérinaires autorisés pour les espèces animales et pour les indications thérapeutiques dites "mineures", conséquence de ces exigences réglementaires, est à l'origine du développement de pratiques à risques. La pratique licite des prescriptions "hors AMM" de médicaments vétérinaires par les docteurs en médecine vétérinaire, ainsi que les utilisations illicites de substances actives autorisées, susceptibles de porter atteinte à la santé animale, à la santé publique, et à l'environnement, représentent un véritable problème de santé publique. / The veterinary pharmaceutical industry has to satisfy numerous specific needs due to the wide variety of the animal species and diseases, to answer the high demand of innovation as well as to maintain on the market the "old" veterinary medicines. The veterinary medicine is the object of a scientific evaluation, intended to guarantee its quality, its efficiency and its security.The risks related to its use for the animal but also and especially for the human (as user of the aforementioned medicine and as consumer of foodstuffs of animal origin), and for the environment, had leddriven to the regulatory requirements governing for veterinary medicinal products being increasingly tightened.The lack of authorized veterinary medicines for the "minors" animal species and therapeutic uses, consequence of these regulatory requirements, is at the origin of the development of risky practices. The licit practice of prescriptions " out of official authorization " of veterinarian medicines from doctors of veterinarian medicine, as well as the illicit uses of authorized active substances, susceptible to strike a blow at the animal health, at the public health, as well as the environment, represent a true public health issue.