Actualmente, la importancia de contar con vacunas que permitan inmunizar a la población mundial ha ido en crecimiento, no solo en los países más desarrollados, sino también en los países en vías de desarrollo (PED). Es por ello, la relevancia que tiene la correcta gestión logística de la cadena de frío en el proceso de importación de vacunas termosensibles, puesto que, por la naturaleza de la mercancía, una variación en la temperatura puede ser perjudicial para la eficiencia de los biológicos, a tal punto de causar una pérdida. Perú es considerado un PED y el crecimiento de los planes de vacunación han obligado que se realicen mejoras en la cadena de frío de las vacunas para hacer eficiente su transporte y distribución. Por lo cual, para estudiar esta problemática la presente tesis analizó la relación entre la gestión logística y la cadena de frío de las importaciones peruanas de vacunas pertenecientes a la SPN N° 30.02.20.9000 en el periodo 2016 al 2020. Mediante la metodología con enfoque cualitativo, a través de entrevistas a especialistas, empresas importadoras y entidades reguladoras de la industria farmacéutica. Se pudo determinar que existe relación entre las variables de estudio y se sustenta a partir de la influencia que los factores almacenaje, equipos contenedorizados y los dispositivos de control de temperatura tienen sobre estas variables. Se recomienda tomar en cuenta para futuros estudios el rol del Estado en el fortalecimiento e implementación de la cadena de frío en Perú. / Currently, the importance of having vaccines that allow the world's population to be immunized has been growing, not only in the most developed countries, but also in developing countries (DC). That is why the relevance of the correct logistics management of the cold chain in the import process of heat-sensitive vaccines, since, due to the nature of the merchandise, a variation in temperature can be detrimental to the efficiency of biologicals. , to the point of causing a loss. Peru is considered a DC and the growth of vaccination plans has forced improvements to be made in the cold chain of vaccines to make their transportation and distribution efficient. Therefore, to study this problem, this thesis analyzed the relationship between logistics management and the cold chain of Peruvian imports of vaccines belonging to SPN N ° 30.02.20.9000 in the period 2016 to 2020. Using the methodology with a focus qualitative, through interviews with specialists, importing companies and regulatory entities of the pharmaceutical industry. It was possible to determine that there is a relationship between the study variables and it is based on the influence of the factors: storage, containerized equipment and temperature control devices have on these variables. It is recommended to consider for future studies the role of the State in the strengthening and implementation of the cold chain in Peru. / Tesis

This study offers insight into the perceived leadership behaviour of sales managers in a pharmaceutical organisation in South Africa. The study specifically investigated the extent of the relationship between leadership behaviour of sales managers and motivation of sales teams during the implementation of strategic alliances. The study followed a mixed methods approach and had a correlational research design. The population in this study was the fifty four (54) sales representatives and their respective sales managers of the six sales teams identified, who are directly responsible for implementing strategic alliances. The population was demarcated into six (6) sales teams with each team reporting to a separate sales manager. Inferential and descriptive statistics were used to analyse the data. The quantitative data were analysed using Pearson’s correlation coefficient (r). The qualitative component was analysed using a content analysis. The findings of the correlation analysis suggest that an overall positive and moderate relationship exist between autocratic leadership behaviour of sales managers and the motivation of sales teams. A similar relationship exists between team leadership and extrinsic motivation. A positive and weak relationship exists between directive and supportive leadership and motivation. Similarly, a positive and weak relationship exists between team leadership and intrinsic motivation. However, the extent to which these relationships exist varies between the sales teams. The findings of the content analysis indicate that task-oriented leadership behaviour may exert the strongest motivator for sales teams when implementing strategic alliances. / Business Management / M. Com. (Business Management)

The aim of the diploma thesis is to describe and analyse information sources, which are useful for the molecules portfolio selection suitable for the future development of a generic drug. These information sources should be examined on the case study of the portfolio selection in a given therapeutic area. The topic of the diploma thesis is presented in the context of basic principles and functions of the generic farmaceutical industry and its information needs. The introductory chapter characterizes the farmaceutical industry in general and warn on a competitive environment, which the farmaceutical companies can succeed in thanks to the advanced methods of the business intelligence. The second chapter focuses on the differences betwen the generic and original pharmaceutical industry, a drug lifecycle is also introduced there. The next chapter specifies the methods of the business intelligence in the generic pharmaceutical industry on the ground of its information needs. The fourth chapter plays a key role. First of all, it introduces general characteristics of information sources used in the strategic portfolio management. Secondly, the detailed description and analysis of eight main information sources used by the generic companies within business intelligence follows. In the last chapter these...

The aim of the diploma thesis is to describe and basically analyze representative databases and digital libraries that focus on pharmaceutical disciplines. The introductory chapter is concerned with related terminology, while the following chapters refer to significant subjects and principles in the field of pharmaceutical industry, and also to important classification systems and retrieval languages that can be found in some of the described resources. The fifth chapter focuses on pharmaceutical information resources which are offered by some of the world's leading database service companies. The sixth chapter contains a description and a basic analysis of 10 representative electronic resources for pharmaceutical disciplines. The empirical section of this diploma thesis consists of three major parts. One of them is a subject coverage analysis of bibliographic databases MEDLINE and EMBASE from the viewpoint of pharmaceutical information. Secondly, it contains a presentation of an indicative survey that is related to using electronic information resources by a commercial and a nonprofit subject. The last chapter deals with information brokering that is presented on example of the Medistyl company. Keywords Pharmaceutical industry, pharmacy, pharmacovigilance, factographic databases, bibliographic...

Die Arzneimitteldistribution in Deutschland ist maßgeblich vom historischen Leitbild "des Apothekers in seiner Apotheke" geprägt und unterlag nur geringfügigen Änderungen. Die regulativen Bestimmungen, insbesondere das Fremdbesitzverbot, die eingeschränkte Mehrbesitzerlaubnis und die Apothekenbetriebsordnung, werden auf ihre Effektivität hinsichtlich einer ordnungsgemäßen Arzneimittelversorgung der Bevölkerung und ihre Effizienz untersucht. Hierbei werden alle relevanten Kräfte in der Arzneimitteldistribution kritisch untersucht und deren Verhandlungsposition dargestellt. Im nächsten Schritt wird ein Konzept zur optimalen Arzneimitteldistribution aus volkswirtschaftlicher Sicht entwickelt. Hierbei werden eine Abschaffung des Fremdbesitzverbotes, die Aufhebung der eingeschränkten Mehrbesitzerlaubnis und tiefgreifende Änderungen an der Apothekenbetriebsordnung vorgeschlagen. Diese Schritte sind aus volkswirtschaftlicher Sicht notwendig, um eine effektive und effiziente Arzneimitteldistribution zu gewährleisten.:1 Einführung … 1 1.1 Gesundheit und Gesundheitsausgaben … 1 1.2 Gesundheitsausgaben, Arzneimittel und Arzneimitteldistribution … 5 1.3 Problemstellung und Zielsetzung der Arbeit, Vorgehensweise … 7 1.4 Gegenwärtiger Stand der Forschung - Literaturüberblick … 11 2 Theoretischer Bezugsrahmen … 16 2.1 Terminologische Definitionen … 16 2.2 Auswahl des theoretischen Bezugssystems … 16 2.2.1 Das Structure-Conduct-Performance-Modell … 17 2.2.2 Strategiebestimmende, kompetitive Marktkräfte … 19 2.2.3 Modellsynthese … 20 3 Volkswirtschaftliche Effektivität und Effizienz in der Arzneimitteldistribution … 21 3.1 Funktion des Wettbewerbs … 21 3.2 Gütereigenschaften von Arzneimitteln … 22 3.3 Regulierungstheorie … 23 3.3.1 Marktmacht … 25 3.3.2 Externe Effekte … 26 3.3.3 Öffentliche Güter … 27 3.3.4 Unvollkommene Informationen … 28 3.4 Das Ziel: Ordnungsgemäße Arzneimittelversorgung … 30 3.4.1 Flächendeckende Versorgung … 32 3.4.2 Zeitliche Zugänglichkeit … 34 3.4.3 Quantitative und qualitative Versorgung … 35 3.4.4 Angemessenes Preisniveau … 36 4 Marktstruktur, Marktverhalten und kompetitive Kräfte in der deutschen Arzneimitteldistribution … 37 4.1 Die Marktsegmente … 37 4.2 Kompetitive Kräfte … 39 4.2.1 Wettbewerb zwischen Apotheken … 40 4.2.1.1 Produktpolitik … 47 4.2.1.2 Werbestrategie … 49 4.2.1.3 Preisstrategie … 49 4.2.1.4 Apothekenkooperationen … 52 4.2.2 Verhandlungsmacht von Leistungsnehmern … 59 4.2.2.1 Apothekenkunden … 59 4.2.2.1.1 RX … 66 4.2.2.1.1.1 Patentgeschützte RX … 66 4.2.2.1.1.2 RX-Generika … 66 4.2.2.1.2 OTC … 67 4.2.2.1.3 Freiwahl … 68 4.2.2.2 Krankenkassen … 69 4.2.2.2.1 RX … 70 4.2.2.2.1.1 Patentgeschützte RX … 71 4.2.2.2.1.2 RX-Generika … 72 4.2.2.2.2 OTC … 74 4.2.3 Verhandlungsmacht der Leistungslieferanten … 74 4.2.3.1 Der pharmazeutische Großhandel … 75 4.2.3.2 Die pharmazeutische Industrie … 81 4.2.3.2.1 RX … 84 4.2.3.2.1.1 Patentgeschützte RX … 84 4.2.3.2.1.2 RX-Generika … 85 4.2.3.2.2 OTC … 85 4.2.3.2.3 Freiwahl … 87 4.2.3.3 Die Ärzte … 88 4.2.4 Gefahr durch Substitute … 90 4.2.5 Potenzielle neue Konkurrenten … 91 4.2.5.1 Versandhandelsapotheken … 92 4.2.5.2 Pick-up-Modelle … 100 4.2.5.3 Selbstbedienungsterminals … 102 4.2.5.3.1 Geografische Ausweitung … 102 4.2.5.3.2 Ausweitung der Versorgungszeit … 103 5 Ergebnisse der derzeitigen Marktstrukturen … 104 5.1 Effektivität – Zielerreichung der ordnungsgemäßen Arzneimittelversorgung … 104 5.2 Effizienz … 108 5.2.1 Wirtschaftliches Ergebnis der deutschen Apotheken … 108 5.2.2 Gewinne und Kennziffern der Apotheken im Vergleich zum Einzelhandel …113 5.2.3 Einkommen der Apotheker im Vergleich zu anderen freien Berufen … 114 5.2.4 Internationaler Vergleich … 115 5.3 Ziele der Wettbewerbstheorie … 118 6 Marktstruktur, Marktverhalten und Marktergebnis als Ansatzpunkte zur Neugestaltung der Arzneimitteldistribution … 119 6.1 Marktergebnis … 119 6.2 Marktverhalten … 120 6.3 Marktstruktur … 120 7 Handlungsempfehlungen – Konzeptionelle Neugestaltung der Arzneimitteldistribution aus volkswirtschaftlicher Sicht …121 7.1 Ordnungsgemäße Arzneimittelversorgung der Bevölkerung … 122 7.2 Ordnungsgemäßer Apothekenbetrieb … 123 7.3 Marktzutrittsbarrieren … 125 7.3.1 Berufsqualifikation … 125 7.3.2 Fremdbesitz … 126 7.3.3 Mehrbesitz … 128 7.3.4 Apothekenbetriebsordnung … 129 7.3.4.1 Ausstattung der Geschäftsräume … 130 7.3.4.2 Freiwahlanforderungen … 131 7.4 Apothekenpflichtigkeit von Arzneimitteln … 131 7.4.1 OTC … 131 7.4.2 RX … 132 7.5 Mehrwertsteuersatz … 133   8 Zusammenfassung … 138 8.1 Zusammenfassung der Ergebnisse … 138 8.2 Ausblick und zukünftiger Forschungsbedarf … 139 Anhang 1: Übersicht über gesetzliche Regelungen des Arzneimittelmarktes seit 2002 … 141 Anhang 2: Empirische Untersuchung über den deutschen Apothekenmarkt … 143 2.1 Auswertung OTC-Industrie … 144 2.2 Auswertung Apothekenkooperationen … 145 2.3 Auswertung Versandhandelsapotheken … 146 2.4 Auswertung Freiwahlindustrie, nicht apothekenexklusiv … 147 2.5 Auswertung Freiwahlindustrie, apothekenexklusiv … 148 2.6 Auswertung Category-Management-Projekt … 150 Literaturverzeichnis … 151

En la industria farmacéutica los estudios de estabilidad son de vital importancia, pues asegura la eficacia y calidad del producto que ofrece a la población. Todos los productos farmacéuticos deben tener un período de investigación con el fin de determinar su vida útil. La presente propuesta de tesis está enfocada en el proceso de estudio de estabilidad, cuyo problema central se encuentran en las actividades manuales de la planificación y monitoreo del estudio, la deficiencia de lo descrito afecta el rendimiento del proceso y genera incertidumbre en la toma de decisiones estratégicas. En consecuencia, la propuesta de solución se justifica en el diseño de una arquitectura tecnológica enfocada en la automatización del pronóstico y seguimiento de la vida útil de los productos fabricados en un laboratorio del sector farmacéutico, usando Web API REST y modelos estadísticos, permitiendo el monitoreo y control eficiente del proceso. Para lograr el éxito del proyecto, se ha analizado al objeto de estudio, identificando el problema principal. En la gestión del proyecto hacemos uso de los diversos artefactos y las buenas prácticas justificadas en la Guía del PMBOK®️. Durante el diseño de la arquitectura empresarial se hizo uso del marco de trabajo Zachman con la metodología de arquitectura TOGAF. Asimismo, se presenta el modelado del proceso referente a la situación actual (AS-IS) usando la notación BPMN. Finalmente, se identifican los componentes tecnológicos de la arquitectura del software utilizando conceptos de ingeniería, tácticas de diseño y representando la arquitectura del software desde un alto nivel a un nivel detallado con el uso del Modelo C4. / In the pharmaceutical industry, stability studies are of vital importance, as it ensures the efficacy and quality of the product that it offers to the population. All pharmaceutical products must have an investigation period in order to determine their shelf life. This thesis proposal is focused on the stability study process, whose central problem lies in the manual activities of planning and tracking of the study, the deficiency of what is described affects the performance of the process and generates uncertainty in decision-making strategic. Consequently, the solution proposal is justified in the design of a technological architecture focused on the automation of forecasting and monitoring of the shelf life of products manufactured in a laboratory of the pharmaceutical sector, using Web API REST and statistical models, allowing the monitoring and an efficient process control. To achieve the project success, the object of study has been analyzed, identifying the main problem. In the project management, we make use of the various artifacts and good practices justified in the PMBOK®️ Guide. During the design of the enterprise architecture, we used the Zachman framework with the TOGAF architecture methodology. In addition, the modeling of the process referring to the current situation (AS-IS) is presented using the BPMN notation. Finally, the technological components of the software architecture are identified using engineering concepts, design tactics and representing the software architecture from a high level to a detailed level with the use of the C4 Model. / Tesis

Globalization and market competition drives new product development. As a consequence, companies are forced to eliminate products more frequently. However, the process of eliminating products is often overlooked both in academia and in practice. Omitting the product elimination process can lead to production inefficiencies and unnecessary costs of retaining the products. The results in this thesis discovers inconsistencies in the present product elimination process at PharmaCompany. The inconsistencies are grouped in the four categories: Interaction & Collaboration, External Analysis, Resource Prioritization & Decision Making, Proactivity Analysis. The main suggested improvements comprise a clearer internal communication, increased documentation and restructuring the current process design. In addition, reframing the current elimination process to emulate the academical approach is suggested in order to further legitimize the elimination process and increase interest on the area. The thesis concludes that a more standardized elimination process can lead to increased efficiency by adopting additional filters to identify and analyze underperforming products. Furthermore, the thesis increases awareness of the topic of product elimination and enhances the knowledge within the research area. By linking the product elimination process to the resource allocation process, the thesis marks the overall neglect of the topic, and gives insights on the need for increased attention towards the product elimination process. / Globaliseringen och ökad konkurrens har drivit på ny produktutveckling. Som en konsekvens tvingas företag att eliminera produkter mer frekvent. Borttagning av produkter har dock förbisetts både i den akademiska världen och i praktiken till förmån för andra forskningsämnen. Att utelämna produkt elimineringsprocessen kan leda till produktionsineffektivitet och onödiga kostnader för att behålla produkterna. Avhandlingen resulterar i upptäckten av flera brister i den nuvarande produktelimineringsprocessen på PharmaCompany. Bristerna är grupperade i större kategorier, Interaction & Collaboration, External Analysis, Resource Prioritization & Decision Making, Proactivity Analysis. De viktigaste föreslagna förbättringarna innefattar tydligare intern kommunikation, ökad dokumentation och omstrukturering av den nuvarande processdesignen. Dessutom föreslås omramning av den nuvarande eliminationsprocessen för att efterlikna den akademiska metoden för att ytterligare legitimera eliminationsprocessen och för att få högre prioritet inom resursallokeringsprocessen. Avhandlingen drar slutsatsen att en mer standardiserad eliminationsprocess kan hjälpa processen att bli effektivare genom att använda fler filter för att identifiera och analysera svaga produkter. Dessutom ökar avhandlingen medvetenheten om ämnet produkteliminering och förstärker kunskapen inom forskningsområdet. Genom att länka produktelimineringsprocessen till resursallokeringsprocessen markerar avhandlingen den övergripande försummelsen av ämnet och ger insikter om behovet av produktelimineringsprocessen behöver få högre fokus och forskning.

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[pt] A tese investiga as etapas do ciclo de planejamento de vendas e operações (S&OP), ampliando o entendimento sobre as etapas pouco pesquisadas do Global Roll-up e Global Executive Meeting. Apresenta um estudo de caso múltiplo, envolvendo cinco importantes subsidiárias latino-americanas de quatro corporações multinacionais. Dois modelos de S&OP são usados para orientar as observações e análises de campo, auxiliando na caracterização do fenômeno S&OP. Acadêmicos e profissionais podem obter conhecimento em primeira mão sobre como as etapas de Global Roll-up e Global Executive Meeting são conduzidas em corporações multinacionais para melhorar seus processos de planejamento. O papel do setor de finanças nos ciclos de S&OP/ Planejamento Integrado de Negócios (IBP) também é examinado e discutido em detalhe, fornecendo informações e ideias úteis para melhorar esses processos em outras organizações, abordando outra lacuna de pesquisa. Os resultados indicam que há desafios para consolidar e usar informações coletadas de várias subsidiárias em diferentes contextos em todo o mundo, mas benchmarking interno e compartilhamento de melhores práticas são explorados, bem como oportunidades de negócios entre países em relação a excessos de estoque, possibilidades de expansão do portfólio e utilização de capacidade ociosa. Adicionalmente, as observações permitiram concluir que o envolvimento precoce do setor de finanças no ciclo de S&OP é benéfico para o negócio, agregando valor ao processo decisório nas etapas iniciais e assumindo um papel central nas etapas de Premeeting e Executive Meeting do ciclo de S&OP. / [en] The thesis investigates the sales and operations planning (S&OP) cycle steps, expanding the understanding about the under-researched Global Roll-up and Global Executive Meeting steps. It presents a multiple case study embracing five important Latin American subsidiaries of four multinational corporations. Two S&OP frameworks are used to guide the field observations and analysis, aiding to improve the S&OP phenomenon s characterization. Scholars and practitioners can gain first-hand knowledge about how Global Roll-up and Global Executive Meeting steps are conducted in multinational corporations to improve their planning processes. The role of finance in S&OP / Integrated Business Planning (IBP) cycles is also examined and discussed in detail providing useful insights to improve these processes in other organizations, addressing another research gap. Findings indicate that there are challenges to consolidate and use information gathered from multiple subsidiaries in different contexts worldwide but internal benchmarking and sharing of best practices are explored as well as business opportunities among countries regarding inventory excess, portfolio expansion possibilities, and spare capacity utilization. Additionally, observations led to the conclusion that early involvement of finance in the S&OP cycle is beneficial for the business, adding value to the decision making process in the initial steps and taking a central role in the Pre-meeting and Executive Meeting steps.

PhD (Department of Chemistry, Faculty of Applied and Computer Sciences), Vaal University of Technology. / This research has investigated the effects of conjugation on the visible light absorption capacity of polyene modified TiO2 nanoparticles as well as the efficiency of these nanoparticles for the mineralisation of acetaminophen (APAP), a non-antibiotic and chloramphenicol (CAP), an antibiotic pharmaceutical compound (PC) which are commonly used worldwide. The efficiency of polyene modified TiO2 (CPE-TiO2) compared with bare TiO2 was further assessed for the mineralisation of the selected PCs under visible light. To achieve this aim, the synthesised nanoparticles were appropriately characterised and tested for the photocatalytic degradation of acetaminophen (APAP) and chloramphenicol (CAP), under visible light. Furthermore, the mechanism and the kinetics of photocatalytic degradation of the PCs were investigated by using high-performance liquid chromatography (HPLC) to monitor the photodegradation intermediates, e.g. Hydroquinone, p-nitrophenol and oxamic acid. The DRS UV-vis spectra result of the CPE-TiO2 indicated that it has a lower band-gap than bare TiO2 nanoparticles and demonstrated a better absorption ability in the wavelength range of 400-800 nm. This result was further confirmed by other optical analyses, such as electrochemical impedance spectrometry (EIS) and photoluminescence (PL). The analysis indicated a less recombination rate of electron/hole pairs in CPE-TiO2 compared to TiO2. Notably, CPE-TiO2 nanocomposite exhibited higher photocatalytic properties for both pollutants, compared to bare TiO2 under visible light. Importantly, photocatalytic degradation experiments demonstrated that the CPE modified nanoparticles were significantly more efficient for PCs degradation (94.21 % for APAP and 80.47% for CAP) compared to bare TiO2 (27.12% for APAP and 36.12% for CAP). The role of CPE-TiO2 photocatalysis in degrading APAP and CAP was examined by varying experimental parameters such as PC concentrations, catalyst loading and solution pH. All the parameters were observed to influence the degradation of the PCs to some extent, albeit, at optimum conditions, most of these PCs were degraded within 210 minutes of visible light irradiation. A significant relationship between the ionic state (+ve or -ve based on the pH) of the solution and CPE-TiO2 photocatalytic process was observed. For the mineralisation, CPE-TiO2 photocatalysis led to higher oxidation rates compared to direct photolysis and bare TiO2 photocatalysis. The results confirm that the co-existence of multiple bonds in poly-conjugated carbon chains with a reduced band-gap in CPE-TiO2 composite were able to enhance charge separation and migration as well as improve the photocatalytic efficiency. This study has clearly demonstrated that polyene modified TiO2 nanoparticles can be applied to degrade PCs in aqueous solution and offers an attractive option for small-scale pharmaceutical wastewater treatment. However, the complex nature of real effluents with co-existing pollutants and higher levels of organic and inorganic matter may call for possible coupling of a biological process as pre- or post-treatment to improve their biodegradability.