The aim of this study is to investigate the optimisation of production planning- and scheduling in a pharmaceutical facility using DES.Research questions: “How can DES be used to achieve flexibility and efficiency in a pharmaceutical facility?” and “How can DES be used to increase efficiency of the resource allocation in a pharmaceutical facility?”Methodology: This study has been compared to a deductive- and a quantitative research approach where a process simulation has been modelled. The theoretical framework was based on books and scientific publications. Empirical data was collected through unstructured observations at the production site, frequent meetings together with the company and through the company’s database Discoverant. Based on the results from the simulation model conclusions could be drawn.Conclusion: The study concluded that there are bottlenecks at the beginning of the processes in all three production flows for Medicine A, Medicine B and Medicine C. If these are raised it would generate greater flexibility and efficiency in the production. There were also indications of a new allocation of resources that would raise efficiency in the production, thus making it possible to increase the output from the production. / Syftet med studien är att undersöka optimering av produktionsplanering- och schemaläggning inom en läkemedelsproduktion med användning av DES.Frågeställningar: ”Hur kan DES användas för att uppnå flexibilitet och effektivitet i en läkemedelsproiduktion?” och ”Hur kan DES användas för att öka effektiviteten kring användandet av resurser i en läkemedelsproduktion?”Metod: Denna studie har liknats vid en deduktiv- och en kvantitativ forskningsansats där en processimulering utformats. Den teoretiska referensramen baserades på böcker och vetenskapliga publikationer. Empirisk data samlades in genom ostrukturerade observationer i produktionen, regelbundna möten tillsammans med företaget och genom företagets databas Discoverant. Baserat på resultaten från simuleringsmodellen kunde slutsatser dras.Slutsats: Studiens slutsats landade i att det finns flaskhalsar i början av alla tre produktionsflöden för Medicin A, Medicin B och Medicin C. Om dessa kan höjas skulle det generera en högre flexibilitet och effektivitet i produktionen. Det finns också tecken som visar på att en ny resursfördelning hade höjt effektiviteten i produktionen, därmed gjort det möjligt att producera mer produkter.

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The global pharmaceutical industry is a highly competitive and rapidly changing environment, defined by rigorous regulations and a constant need for new discoveries and developments. Pharmaceutical MNCs operate in a variety of legal and cultural contexts, making it crucial for them to possess a thorough understanding of local laws and customs to ensure regulatory compliance and long-term business sustainability. The combination of a strong economy, a robust research and development infrastructure, and a highly skilled workforce has positioned Sweden as an appealing destination for pharmaceutical MNCs seeking to expand their global presence. This thesis investigates the impact of Swedish labour law, specifically the Co-Determination Act (MBL) and the Employment Protection Act (LAS), on multinational pharmaceutical companies operating in Sweden. Through a qualitative study incorporating semi-structured interviews with HR directors from two leading pharmaceutical MNCs and legal experts from two corporate law firms, the study explores how these regulations influence operational strategies, decision-making processes, and human resource management practices. The findings highlight the complexities MNCs face in complying with MBL and LAS, including extended decision-making timelines and challenges with employee retention and termination due to the “last in, first out” principle. However, the study also identifies benefits such as enhanced employee morale and trust, which contribute to a positive work environment. The conclusions suggest that while these two regulations impose significant operational constraints, they also offer strategic advantages that can lead to improved employee engagement and organisational stability. While primarily focusing on the management perspective within MNCs, this study leaves the employee viewpoint unexplored. Future research could explore the employeee xperience to provide a more comprehensive understanding of the impact of MBL and LAS. Additionally, while centred on the pharmaceutical industry, the findings may have broader implications for other industries and could pave the way for further research into how these regulations affect various industries and potentially influence foreign direct investment in Sweden. Given the limited sample size, further research with a larger and more diverse sample is also warranted to validate and generalise these results. Nevertheless, this study provides insights for new MNCs navigating the Swedish labourlaw landscape, aiding in strategic planning and decision-making.

Denna studie undersöker hur utgående logistik inom läkemedelsindustrin kan förbättras med hjälp av diskret event simulering (DES) och prognostisering. Komplexa logistiksystem och stora variationer kännetecknar outbound-logistik inom denna bransch, vilket leder till utmaningar som kapitalbindning, kapacitetsbegränsningar och begränsad lageryta. Simuleringar användes för att identifiera flaskhalsar och utvärdera förbättringsförslag. Att kombinera DES med prognostisering möjliggjorde analys av framtida utgående volymer. En simuleringsmodell utvecklades för att representera logistiksystemet, med hänsyn till faktorer som tillgängliga resurser och ledtider. Studien visade att det nuvarande systemet inte kunde hantera den prognostiserade ökningen av efterfrågan på den europeiska marknaden utan modifieringar. Modellen verifierades och validerades med hjälp av verklig data som sedan användes för att utvärdera tre förbättringsförslag: att lägga till en extra etiketteringsmaskin, öka antalet lagringsplatser för Europapallar och förlänga slottiderna för lastbilshämtningar. Resultatet visade att det skulle vara nödvändigt att implementera alla tre förslagen för att möta den prognostiserade efterfrågan. Denna strategi kan hjälpa läkemedelsföretag att identifiera och hantera potentiella problem i sin utgående logistik, vilket säkerställer effektiva och punktliga leveranser. / This study investigates how outbound logistics can be improved in the pharmaceutical industry using discrete event simulation (DES) and forecasting. Complex logistic systems and high variation characterize outbound logistics in this industry, leading to challenges like capital tie-ups, capacity constraints, and limited warehouse space. Simulations were used to identify bottlenecks and evaluate improvement proposals. Combining DES with forecasting allowed for the analysis of future outbound volumes. A simulation model was developed to represent the outbound logistics system, considering factors like available resources and lead times. The study found that the current outbound logistics system cannot handle the forecasted increase in demand for the European market without modification. The model was verified and validated using real-world data to evaluate three improvement proposals: adding an additional labeling machine, increasing the number of storage bays for Europe-bound pallets, and adding slot times for truck pickups. The results showed that implementing all three proposals would be necessary to meet the projected demand. This approach can help pharmaceutical companies identify and address potential issues in their outbound logistics, ensuring efficient and timely deliveries.

The South African health care environment is a two-tier health care delivery system consisting of the public sector and the private sector. The focus of this study is on the private health care sector. Private health care is funded by medical schemes through employer and employee contributions. The private sector is also the most profitable sector for multinational pharmaceutical organisations to market and sell their products within the South African health care environment. The major cost saving initiative by employers and medical schemes in the private health care sector has also been the introduction of managed health care initiatives. The goal of managed health care is to establish a system which delivers value by giving people access to quality and cost-effective healthcare. The new reality of managed health care initiatives are changing the boundaries of the South African pharmaceutical industry. The managed health care wake is overturning the business processes which made the pharmaceutical industry so successful and are rendering obsolete the industry's conventional models of corporate strategy and management systems. In the context of these turbulent changes, pharmaceutical companies are being forced simultaneously to develop new strategic approaches for the future, design new business processes which will link them more firmly to their new customers, and implement the cultural changes neccessary to accomplish the transformation from yesterday's successful pharmaceutical company to tomorrow's customer-led, integrated health care supplier. The way forward lies in three organising concepts. The first is cutomer alignment. The effort of transformation must start with an understanding of how the customer defines the value of the services and/or products offered by the organisation. Everything that follows involves aligning internal processes with external contingencies. The second is sequencing. It is vital to understand not just what needs to happen first in the transformation process, but also what the subsequent steps is and in what order the steps need to be undertaken. The third organising concept is learning. The sequence of interventions that lead to organisational transformation must occur in such a way as to maximize the ability of the organisation to learn: from customers and the marketplace, and from itself. / Business Management / D.B.L.

劉鵬. / Thesis (doctoral)--Chinese University of Hong Kong, 2008. / Includes bibliographical references (p. 450-498). / Electronic reproduction. Hong Kong : Chinese University of Hong Kong, [2012] System requirements: Adobe Acrobat Reader. Available via World Wide Web. / Abstracts in Chinese and English. / Liu Peng.

The South African health care environment is a two-tier health care delivery system consisting of the public sector and the private sector. The focus of this study is on the private health care sector. Private health care is funded by medical schemes through employer and employee contributions. The private sector is also the most profitable sector for multinational pharmaceutical organisations to market and sell their products within the South African health care environment. The major cost saving initiative by employers and medical schemes in the private health care sector has also been the introduction of managed health care initiatives. The goal of managed health care is to establish a system which delivers value by giving people access to quality and cost-effective healthcare. The new reality of managed health care initiatives are changing the boundaries of the South African pharmaceutical industry. The managed health care wake is overturning the business processes which made the pharmaceutical industry so successful and are rendering obsolete the industry's conventional models of corporate strategy and management systems. In the context of these turbulent changes, pharmaceutical companies are being forced simultaneously to develop new strategic approaches for the future, design new business processes which will link them more firmly to their new customers, and implement the cultural changes neccessary to accomplish the transformation from yesterday's successful pharmaceutical company to tomorrow's customer-led, integrated health care supplier. The way forward lies in three organising concepts. The first is cutomer alignment. The effort of transformation must start with an understanding of how the customer defines the value of the services and/or products offered by the organisation. Everything that follows involves aligning internal processes with external contingencies. The second is sequencing. It is vital to understand not just what needs to happen first in the transformation process, but also what the subsequent steps is and in what order the steps need to be undertaken. The third organising concept is learning. The sequence of interventions that lead to organisational transformation must occur in such a way as to maximize the ability of the organisation to learn: from customers and the marketplace, and from itself. / Business Management / D.B.L.

Résumé : À 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 des 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. // Abstract : 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 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 time consuming, require large amounts of material 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.

Thesis (MA)--Stellenbosch University, 2005. / ENGLISH ABSTRACT: This thesis is an explanatory study into civil society's increased influence in global governance. More specifically this situation is examined by looking at the generic medicine debate that came in the wake of the passing of the Medicines and Related Substances Act by the South African government in 1997. This debate gained worldwide attention and touched some of the prevailing inequalities between the developed world and the developing world in our globalised society. The research question that is addressed here is to what extent did civil society influence the signing of the Doha Declaration of the TRIPS Agreement and Public Health by the members of the World Trade Organisation (WTO) in 2001? In doing so, this thesis looks at the role of the US government, the South African government, the pharmaceutical industry, the WTO's TRIPS Agreement and civil society in the form of nongovernmental organisations like Treatment Action Campaign (TAC), Oxfam and Medecines Sans Frontieres (MSF). The study applies a constructivist approach in order to analyse how civil society used global advocacy networks to inform and communicate the normative concerns regarding South Africa and developing countries' lack of access to HIVand AIDS drugs. Moreover, it examines how civil society's use of moral authority challenged the regulative power of the WTO. The study concludes that civil society played a vital role in influencing the WTO member states' decision to sign the Doha Declaration on the TRIPS Agreement and Public Health. However, it was not only civil society's ability to set the agenda concerning the HIV/AIDS pandemic, but also the content of the normative concerns themselves that help explain its success. Consequently, the study further concludes that civil society's success in this specific case must be seen in light of its growing influence in challenging global governance. / AFRIKAANSE OPSOMMING: Hierdie tesis is 'n verduidelikende studie van die burgerlike samelewing se groeiende invloed in globale regering. Hierdie situasie word meer spesifiek ondersoek deur te kyk na die generiese medisyne debat wat gevoer is na die Suid-Afrikaanse Regering die Medisyne en Verwante Stowwe Wet van 1997 goedgekeur het. Hierdie debat het wêreldwye aandag geniet en het geraak aan sommige van die bestaande ongelykhede wat daar heers tussen die ontwikkelde en ontwikkelende wêreld in die geglobaliseerde samelewing. Die navorsingsvraag wat hier aangespreek word is tot watter mate die burgerlike samelewing die ondertekening van die Doha Verklaring van die TRIPS Ooreenkoms en Publieke Gesondheid deur lede van die Wêreld Handelsorganisasie (WHO) in 2001 beïnvloed het. Deur dit te doen, sal hierdie tesis kyk na die rol van die Amerikaanse regering, die Suid- Afrikaanse regering, die farmaseutiese bedryf, die WHO se TRIPS Ooreenkoms en die burgerlike samelewing in die vorm van nie-regerings organisasies soos die Treatment Action Campaign (TAC), Oxfam en Medecines Sans Frontieres (MSF). Die studie maak gebruik van 'n konstruktiwistiese benadering om 'n analise te doen van hoe die burgerlike samelewing globale ondersteunings netwerke gebruik het om die normatiewe besorgdhede wat heers oor die tekorte in Suid-Afrika en die ontwikkelende lande ten opsigte van toegang tot MIV en VIGS medisyne, toe te lig en te verkondig. Verder ondersoek die studie hoe die gebruik deur die burgerlike samelewing van morele gesag die regulerende mag van die WHO uitgedaag het. Die studie kom tot die gevolgtrekking dat die bugerlike samelewing 'n uiters belangrike rol gespeel het in die WHO lidlande se besluit om die Doha Verklaring van die TRIPS Ooreenkoms en Publieke Gesondheid te onderteken. Dit was egter nie net die burgerlike samelewing se vermoë om die agenda daar te stel ten opsigte van die MIV/VIGS pandemie nie, maar ook die inhoud van die normatiewe besorgdhede self wat bygedra het om hierdie sukses te verduidelik. Gevolglik kom die studie tot die verdere gevolgtrekking dat die burgerlike samelewing se sukses in hierdie spesifieke geval gesien kan word in die lig van sy groeiende invloed in die uitdaging van globale mag en gesag.

Thesis (MBA)--Stellenbosch University, 2004. / ENGLISH ABSTRACT: HIV infection has increased sharply in SA over the past decade, from almost zero to a level where between 4-6 million citizens are estimated to be HIV positive (i.e. around Il percent of the total population). Given the considerable lag and link between the HIV and AIDS epidemic, the mortality consequences of this exponential increase in HIV infection over the 1990s are more or less matter-of-fact over the coming decade; even drastic interventions can do little to avoid this reality, albeit possibly impactingfurther beyond. The health care industry, and more specifically the pharmaceutical industry, is the only industry that can have a direct impact on the outcome of the epidemic in terms of provision of antiretroviral drugs. More importantly, the decision by multinational companies to provide voluntary licensing to local SA pharmaceutical manufacturers for the manufacturing of generic ARVs has gone a long way into achieving the World Health Organisations' objective of providing an ARV cocktail for less than $1,00 per day. The mam aim of the study is to establish and study the micro-economic effect of HIV/AIDS on a South African pharmaceutical manufacturer and to evaluate their HIV/AIDS Policy with the framework of the mV/AIDS & SID Strategie Plan for South Africa 2000-2005. Both qualitative and quantitative methods were used to obtain data from various key informants, manufacturers and market survey companies. The analysis of quantitative data was done using Excel software and a descriptive analysis method was used to interpret the data. The key findings from the study are that Aspen Pharmacare will experience a 20,8 % HIV prevalence rate in 2005, which will progressively increase to a 25,6 % level in 2015. This prevalence level will be severely experienced in the skilled, semi-skilled and unskilled employment of the company during the 2010 period and will start to stabilise in the latter part of 2015. The AIDS prevalence in the company will increase from a 2,0 % level in 2005 to a 4,4 % level in 2015. This increase is largely due to the increase in the prevalence rates in the semi-skilled and unskilled employees. At a senior management level the forecasted number of employees that will have clinical AIDS after 2010 is between 6 and 8. This clearly indicates that mv/AIDS prevalence at this level is independent of race and is lifestyle dependent. If the company were to have the full responsibility for the provision of benefits, based on the current expected employee benefit structures, the direct cost to company would add 10 % to salary and wages by 2005 and around 20 % by 2010. Indirect costs to company, such as recruitment and training, increased labour turnover, lost skills and intellectual property, etc. are estimated to be 2,5 % by 2005 and 5 % by 2010. With the high HIV/AIDS prevalence rates, especially amongst the unemployed, companies will have to carry the costs of their mv/AIDS patients for longer and register then with Aid for AIDS when it becomes too costly. More importantly employers will have to investigate the cost implication of assisting employee dependents, as this will have a direct impact on the morale of the employees. Aspen Pharmacares' mv/AIDS Policy goes beyond the requirements of the mv/AIDS Strategic Plan for SA in terms of the legal and social requirements. The company also has a Corporate Social Investment division that assists many NGOs, clinics, hospitals and communities. Based on the intellectual property, the pharmaceutical competencies and the continuous dialogue that exists between the pharmaceutical industry and the department of health, the researcher concludes, that pharmaceutical companies have an advantage over nonpharmaceutical companies in dealing with the mv/AIDS issues. The paper concludes by suggesting recommendations that companies can adopt to ensure that their mv/AIDS policy can form a significant component of their skills retention strategy. / AFRIKAANSE OPSOMMING: MIV infeksie het skerp gestyg in SA oor die laaste dekade, vanaf amper geen tot 'n vlak waar tussen 4-6 miljoen inwoners beraam word om MIV positiefte wees (minstens 11% van die totale bevolking). Gegee die aansienlike vertraging en skakel tussen die MIV en VIGS epidemie, word die eksponensiële toename in die sterfte syfer as gevolg van MIV infeksies gedurende die jare negentig as vanselfsprekend aanvaar in die komende dekade. Selfs ingrypende veranderinge kan min doen om hierdie katastrofe te keer. Die gesondheidsorg industrie, en meer spesifiek die farmaseutiese industrie is die enigste industrie wat 'n direkte slag kan slaan om die uitkoms van die epidemie te beinvloed, in terme van voorsiening van antiretrovirale medisyne. Die besluit van die multinasionale maatskappye om vrywillige lisensiëring aan plaaslike farmaseutiese maatskappye te bied, vir die vervaardiging van generiese antiretrovirale medisyne, is een stap vorentoe om by die doelwit van die Wereld Gesondheidsorg Organisasie se doelwit van die voorsiening van 'n daaglikse toediening van antiretrovirale medisyne van minder as $1.00 per dag. Die primêre doelwit van hierdie projek is om te bepaal wat die mikro-ekonomiese effek van MIV/VIGS op 'n Suid Afriakaanse farmaseutiese vervaardiger is en hul MIV/VIGS beleid te evalueer binne die raamwerk van die MIV/VIGS en SOS Strategiese Plan vir SA 2000-2005. Beide kwalitatiewe en kwantitatiewe metodes is gebruik om data te verkry vanaf verskeie bronne, vervaardigers en marknavorsings maatskappye. Die kwantitatiewe inligting was geanaliseer deur gebruik te maak van "Excel" sagteware en 'n beskrywende analitiese metode was gebruik om die data te interpreteer. Die hoof bevindinge van die studie is dat Aspen Pharmacare 'n MIV infeksie vlak van 20.8 % in 2005 sal ondervind, wat progressief sal toeneem tot 25,6 % in 2015. Hierdie infeksie vlak sal in die geskoolde, semi-geskoolde en ongeskoolde arbeid die ergste voorkom gedurende die 2010 periode en sal dan stabiliseer in die latere gedeelte van 2015. Die VIGS infeksie vlak in die maatskappy sal toeneem vanaf 2,0 % in 2005 tot 'n 4,4 % in 2015. Hierdie toename kan toegeskryf word aan die toename in die infeksie vlakke van die semi-geskoolde and ongeskoolde arbeid. Op die senior bestuurs vlak word beraam dat tussen 6 en 8 werknemers VIGS onder lede sal hê na 2010. Hierdie beraming toon duidelik aan dat MIV/VIGS op hierdie vlak onafhankilik van kleurgroup is en direk leefstyl verwant is. Gebaseer op die huidige verwagte werknemer voordele struktuur, en die feit dat die maatskappy volle verantwoordelikheid sou aanvaar vir die voorsiening van voordele, word beraam dat die direkte koste as gevolg van MIV/VIGS 'n toename van 10 % in 2005 en 20 % in 2010 by salarisse en lone sal voeg. 'n Toename van 2,5 % in 2005 en 5 % in 2010 word beraam vir indirekte koste (werwing van personeel, opleiding, ens.)as gevolg van MIV/VIGS. Met die hoë MIV/VIGS infeksievlakke, veral onder werkloses, sal maatskappye die kostes vebonde aan hul MIV/VIGS werknemers vir langer moet verduur en dan later sulke werknemers registreer by "Aid for AIDS" indien dit onbekostigbaar word. Belangriker is die feit dat werknemers die koste implikasie bepaal in die verband, omdat dit 'n direkte invloed sal hê op werknemer selfvertroue. Aspen Pharmacare se MIV/VIGS beleid bied meer as die wettige en sosiale vereistes soos uiteengesit in die MIV/VIGS en SOS Strategiese Plan vir SA 2000-2005. Die maatskappy het ook 'n Korporatiewe Maatskaplike Beleggings afdeling wat 'n bydra lewer by NGOs, klinieke,hospitale en gemeenskappe. Gebaseer op die intelligensie eiendom, die farmaseutiese bekwaamheid en die aanhoudende gesprekvoering wat bestaan tussen die farmaseutiese bedryf en die department van gesondheid, oortuig die navorser dat farmaseutiese maatskappye 'n voordeel het bo nie-farmaseutiese maatskappye in die hantering van die MIV/VIGS strydvraag. Hierdie studie sluit af met aanbevelings wat maatskappye kan toepas om te verseker dat hul MIV/VIGS beleid 'n betekenisvolle komponent van hul bekwaanheids retensie strategie is.