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De, Francesco Fabrizio. "A comprehensive analysis of policy diffusion : regulatory impact analysis in EU and OECD member states." Thesis, University of Exeter, 2010. http://hdl.handle.net/10036/3022.
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Among the tools available to enhance the rationality of policy formulation, Regulatory Impact Analysis (RIA) has captured the attention of many scholars for its potential to enhance the accountability and transparency of regulatory governance. Although almost all EU and OECD member states have adopted RIA, only a sub- set of small-n case comparative studies on institutional, political and administrative impact have been conducted. By filling this gap in the literature and proposing the rigorous operationalisation of concepts such as adoption, extent of implementation, and learning, this thesis ascertains the extent of interdependency among governments in their choices concerning an innovation of regulatory governance. Methodologically, the dissertation draws on a multi-method approach, consisting of qualitative analysis to track the process of institutionalisation, as well as event history analysis, based on a dataset covering thirty-eight countries from 1968 to 2006. The empirical findings show that diffusion is a multifaceted process. In the decision to adopt RIA, the role of the OECD in translating, packaging, and promoting such administrative innovation coexists with previous innovations and other administrative variables. Yet the impact of interdependency is marginal in the successive phases of implementation and evaluation. Earliness of adoption is the major predictor of the extent of implementation. There is little evidence of interaction and communication among adopters on the subject of their learning experience. On balance, this regulatory governance innovation is a domain of symbolic and rhetorical meanings that is not adequately supported by administrative capacity.
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Adeegbe, Dennis O. "Allogeneic CD4+CD25+Foxp3+ T Regulatory Cells in Autoimmunity and Transplantation Tolerance: Therapeutic Potential and TCR Repertoire Requirement." Scholarly Repository, 2008. http://scholarlyrepository.miami.edu/oa_dissertations/43.
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CD4+CD25+Foxp3+ T regulatory (Treg) cells are critical in maintaining self tolerance and promoting the acceptance of allogeneic tissue/organ grafts. To be widely applied in clinical settings, there needs to be a readily available source of Treg cells, a requirement that is better met if non-histocompatible donor cells could be utilized in adoptive therapy. Therefore, to investigate the therapeutic potential of fully allogeneic Treg cells to control autoimmune disease or allograft rejection, we utilized IL-2R beta-deficient mice that exhibit rapid lethal autoimmunity due to low production of an ineffective population of Treg cells. We show that adoptive transfer of MHC-mismatched Treg cells into IL-2R beta-/- mice resulted in life-long engraftment of the donor cells, which exhibited skewed reactivity toward host alloantigens, and prevented autoimmunity. When such animals received skin grafts, they exhibited tolerance to those grafts that expressed MHC molecules from which the donor Treg cells were derived. Collectively, these data provide proof-of-principle that effective engraftment by allogeneic Treg cells controls autoimmunity and leads to favorable conditions for long-term acceptance of allografts. Current data indicates that CD4+CD25+Foxp3+ Treg cells exhibit a broad TCR repertoire. However, the relationship between this diversity and capacity to control a similarly diverse population of potentially autoreactive T cells remains to be defined. To investigate this issue, we assessed the TCR repertoire of chimeric donor Treg cells in IL-2R beta-/- mice that were adoptively treated with a diverse polyclonal Treg inoculums. We demonstrate that autoimmune disease was fully prevented by engrafted donor Treg cells in spite of a TCR repertoire that is less diverse than the input cells. However, in settings where the input TCR repertoire is limited by utilizing donor Treg cells that express a single TCR beta chain, control of disease was hampered, correlating with a limited TCR alpha repertoire within the engrafting donor Treg cells. Collectively, these findings suggest that for adoptive therapy, a diverse TCR repertoire of input Treg cell inoculums is an essential requirement for effective control of polyclonal autoreactive T cells but perturbations in the repertoire that results in significant limitation to this diversity may compromise Treg cell efficacy at fully keeping autoaggressive cells in check.
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Khumalo, Jermaine. "The temporal requirement of IL-4Rα signalling in allergic asthma and the role of IL-4Rα-responsive Regulatory T cells in restraining allergic airway inflammation." Doctoral thesis, Faculty of Health Sciences, 2019. https://hdl.handle.net/11427/31728.
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Allergic asthma is a chronic inflammatory airway disease driven predominantly by a TH2 immune response to environmental allergens. The asthma pathology is predominantly elicited by IL-4 and IL-13 signalling via IL-4Rα-signalling which is essential for driving TH2-type immunity to allergens. Interestingly, the failure by regulatory T cells to maintain tolerance during allergic asthma, suggested to be driven by TH2 inflammatory signals, still remains elusive and anti-TH2 therapies with the potential to effectively reduce airway obstruction and inflammation in allergic asthma, have had limited success. Therefore, we aimed to investigate the function of IL-4/IL-13 responsive regulatory T cells in a TH2 rich environment and the temporal requirement of IL-4Rα-signalling in asymptomatic and acute airway disease. Objective 1: We investigated potential therapeutic effects of selective inhibition of this pathway in mice with established allergic airway disease and systemically sensitised mice to prevent the onset of the disease. We used RosacreERT2IL-4Rα-/lox mice, a novel, tamoxifen inducible IL-4Rα knockdown model to investigate the role of IL-4/IL-13 signalling during the effector phase of ovalbumin induced allergic airway disease (AAD) and for the onset of the disease. The deletion of the IL-4Rα had a therapeutic effect on established AAD and prevented the development of ovalbumin induced airway hyperreactivity, goblet cell metaplasia and eosinophilia in allergensensitised mice. We concluded that the abrogation of IL-4Rα signalling after allergic sensitisation would have significant therapeutic benefit for TH2 type allergic asthma. Objective 2: The canonical IL-4Rα-signalling, was investigated on its role on Foxp3+ Tregs in allergic asthma with aims to re-establish tolerance during allergic asthma. We used transgenic Foxp3cre IL-4Rα-/lox mice IL-4Rα-/lox mice to investigate the role of IL-4/IL-13 signalling during the induction or maintenance of tolerance in house dust mite-induced ADD. The depletion of IL-4Ra on Foxp3+ Tregs exacerbated airway hyperreactivity and airway inflammation in allergen- sensitised mice. Interestingly, a reduced induction of Foxp3+ Tregs in peripheral tissue and an accompanying increased IL-33 induced ILC2 driven inflammation in the lung responsible for the exacerbation of TH2 acute disease. Conclusively, the IL-4Rα responsive Foxp3+ T regulatory cells are key in maintaining tolerance in type 2 innate immune driven allergic asthma, therefore the TH2 environment has both an innate immune specific regulative role in local lung tissue and induction of Foxp3+ Tregs in peripheral tissue during AAD. A combined targeting of the pathogenic TH2 environment in anti-TH2 therapy and the augmentation of regulatory T cell function in the local lung tissue is necessary to inhibit both adaptive and innate drivers of TH2 inflammation in allergic disease.
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Cavdarovski, Jove, and Jesper Wallvik. "Kapitaltäckningsregler med valfrihet : en kvalitativ studie om bankers frihet att välja beräkningsmetod för kapitalkravet." Thesis, Högskolan Kristianstad, Sektionen för hälsa och samhälle, 2013. http://urn.kb.se/resolve?urn=urn:nbn:se:hkr:diva-10875.
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Purpose: The purpose of this study is to increase the understanding of how a bank’s features and internal factors have affected its choice of method in calculating the capital requirement. Theoretical and Empirical Method: The research strategy of this study has been of a qualitative nature with a deductive approach. The choice of method was depth interviews with respondents from a targeted sample of Swedish banks. These respondents were chosen based on the knowledge they possess as key employees in the capital requirement process and their involvement in choosing their banks’ method for calculating the capital requirement. The interviews were semi-structured, with open questions that allowed a dialogue with the respondents in which they could express their opinions and knowledge regarding the factors affecting their banks’ choice of method. Theoretical Approach: The study is based on the new institutional economics theory of how institutions affect organizational behavior. It’s also based on earlier research within the regulation Basel II by, among others, Hakenes and Schabel (2011), Rime (2005) and Wahlström (2009). Conclusions: The results of this study show that banks have identified different factors that affect their choice of calculation method for the capital requirement. The choice the banks are facing is to keep the standardized method, develop an advanced internal based method, create partnerships with other banks or focus on alternative clientele portfolios. The two factors that were considered to be have the greatest significant for the choice of calculation method were resources associated with the implementation of the IRB approach models and how the banks’ clientele portfolio was designed. How these were distributed and to what extent they influenced the choice was highly individual for the chosen banks.Syfte: Syftet med den här studien är att öka förståelsen om hur en banks förutsättningar och interna faktorer har påverkat dess val av beräkningsmetod för kapitalkravet. Teoretisk och empirisk metod: Forskningsstrategin för studien har varit av den kvalitativa typen med en deduktiv ansats. Valet av metod var djupintervjuer med respondenter från ett målinriktat urval av svenska banker. Respondenterna valdes utifrån de kunskaper som de besitter genom sin position på respektive bank, där deras deltagande i metodvalsprocessen påverkade valet av beräkningsmetod. Intervjuerna var av typen semistrukturerade, med öppna intervjufrågor för att få till en dialog med respondenterna och ta del av deras åsikter och kunskaper gällande de olika faktorerna till metodvalet. Teoretisk referensram: Studien utgick från den nyinstitutionella teorin, om hur institutioner påverkar organisationers beteenden. Den har baserats på tidigare forskning inom regelverket Basel II av bland annat Hakenes och Schnabel (2011), Rime (2005) samt Wahlström (2009). Slutsats: Resultatet av denna studie visar på att bankerna har identifierat olika faktorer som påverkar valet av beräkningsmetod för kapitalkravet. Valet som bankerna står inför är att behålla Schablonmetoden, utveckla en IRK-metod, skapa samarbeten med andra banker eller fokusera på alternativa klientelportföljer. De två faktorer som ansågs ha störst signifikans för valet av beräkningsmetod var resurserna som förknippades med implementeringen av modellerna i IRKmetoden och hur bankens klientelportfölj var utformad. Hur dessa var fördelade och i vilken grad de påverkade valet var högst individuellt för de utvalda bankerna.
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Brolin, Sandra. "Global Regulatory Requirements for Medical Devices." Thesis, Mälardalen University, School of Sustainable Development of Society and Technology, 2008. http://urn.kb.se/resolve?urn=urn:nbn:se:mdh:diva-700.
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Medical devices are becoming more important in the health care sector. One of the major issues for companies developing and producing medical devices is to be updated on the regulatory requirements and implement them in the process. This thesis examines the regulatory requirements for medical devices in Argentina, Australia, Brazil, Canada, India, Japan, Mexico, Russia, South Korea and Taiwan and compares them with the requirements in the European Union.
The conclusion of this thesis is that most countries have similar requirements for registration of medical devices and are striving to harmonize with the GHTF guidelines. A company goes far by following the requirements in EU, USA or the GHTF guidelines.
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Vojkůvka, Adam. "Dopady nových regulatorních požadavků na tržní riziko." Master's thesis, Vysoká škola ekonomická v Praze, 2017. http://www.nusl.cz/ntk/nusl-360519.
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The aim of this master thesis is analyze the impact of new regulatory requirements for market risk in terms of internal approach of the selected portfolio. The first part deals with the definition and calculation methods of risk measures Value at Risk and Expected Shortfall. Furthermore, this part is dedicated to model backtesting and determination of the stress period. The second part describes the development of Basel I-III regulatory requirements for market risk with a focus on internal approaches. The third part focuses on the calculation and subsequent analysis of current and new regulatory reguirements for market risk using the historical simulation method, variance and covariance method and Monte Carlo simulation.
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Powell, Michael D. "Insights Into the Regulatory Requirements for T Follicular Helper Cell Development." Diss., Virginia Tech, 2019. http://hdl.handle.net/10919/89085.
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During the course of an immune response, CD4+ T helper cells differentiate into a number of subsets including: T helper 1 (TH1), TH2, TH17, and T follicular helper (TFH) populations. The functional diversity of CD4+ T effector cells results in a coordinated, pathogen-specific immune response. For example, the production of IFNγ by TH1 cells is vital for the clearance of intracellular pathogens, while TFH cell engagement with cognate B cells is required for germinal center (GC) formation and the generation of pathogen- and vaccine- induced antibody production. The development of CD4+ subsets is contingent on extracellular signals, in the form of cytokines, and downstream transcriptional networks responsible for promoting the unique gene expression profile for each subset while simultaneously suppressing alternative cell fates. However, the exact composition of, and stage-specific requirements for, these environmental cytokines and transcription factor networks in the governance of TFH cell differentiation remain incompletely understood. The work in this dissertation seeks to understand how cell-extrinsic cytokine signals and cell-intrinsic transcription factor activities are integrated to properly regulate TFH cell development. Here, we demonstrate that in response to decreased IL-2 and constant IL-12 signaling, T helper 1 (TH1) cells upregulate a TFH-like phenotype, including expression of the TFH lineage defining transcription factor Bcl-6. Intriguingly, our work established that signals from IL-12 were required for both the differentiation and function of this TFH-like population. Mechanistically, IL-12 signals are propagated through both STAT3 and STAT4, leading to the upregulation of the TFH associated genes Bcl6, Il21, and Icos, correlating with increased B cell helper activity. Conversely, exposure of these TFH-like cells to IL-7 results in the STAT5-dependent repression of Bcl-6 and subsequent inhibition of the TFH phenotype. Finally, we describe a novel regulatory mechanism wherein STAT3 and the Ikaros zinc finger transcription factors Ikaros and Aiolos cooperate to regulate Bcl-6 expression in these TFH-like cells. Collectively, the work in this dissertation significantly advances our understanding of the regulatory mechanisms that govern TFH cell differentiation, setting the basis for the rational design of novel immunotherapeutic strategies and increasingly effective vaccines.Ph. D.
Specialized cells called T helper cells serve as a critical interface between the innate (first line of defense) and adaptive (specialized and long-term) immune systems. During the course of an infection, T helper cells are responsible for orchestrating the immune-mediated elimination of invading viruses, bacteria, and parasites. This wide breadth of functionality is achieved through the formation of distinct T helper subsets including T helper 1 (TH1), TH2, TH17, and T follicular helper (TFH) populations. Individual subsets have distinct developmental requirements and have unique functions within the immune system. For example, TFH cells are required for the production of effective antibodies that recognize invading pathogens, leading to their subsequent elimination. This naturally occurring process is the basis for a number of modern medical therapies including vaccination. Conversely, aberrant generation of antibodies that recognize host tissues can result in the onset of various autoimmune diseases including lupus, multiple sclerosis, and crohn’s disease. Due to the importance of TFH cells to human health, there is intense interest in understanding how these cells are formed. It is recognized that the generation of these therapeutically important immune cells is mediated by numerous cell-extrinsic andintrinsic influences, including proteins in their cellular environment called cytokines, and important proteins inside of the cell called transcription factors. However, as this is a complicated and multi-step process, many questions remain regarding the identity of these cytokines and transcription factors. The work in this dissertation seeks to understand how cellextrinsic cytokine signals and cell-intrinsic transcription factor activities are integrated to properly regulate TFH cell development. Collectively, this body of work significantly advances our understanding of the regulatory mechanisms that govern TFH cell differentiation, setting the basis for the rational design of novel immunotherapeutic strategies and increasingly effective vaccines.
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Sullivan, Mark. "Pollution control upgrade of a hazardous waste incinerator to comply with regulatory requirements." Thesis, This resource online, 1995. http://scholar.lib.vt.edu/theses/available/etd-02132009-170926/.
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Uhl, Juli D. "Hox Specificity: Constrained vs. Flexible Requirements for the PBC and MEIS Cofactors." University of Cincinnati / OhioLINK, 2014. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1397234792.
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Malpass, Katy H. "Regulatory T cells : molecular requirements for their selection and therapeutic use in autoimmune disease." Thesis, University of Edinburgh, 2009. http://hdl.handle.net/1842/4636.
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Regulatory T cells (Tregs), expressing the transcription factor Foxp3, form a key component of peripheral immune tolerance, guarding against auto-aggressive immune responses. Multiple Sclerosis is an inflammatory and demyelinating disease of the central nervous system (CNS) which is largely believed to be mediated by immune components reacting to the self myelin antigens that insulate the nerve fibres. Recent investigations have reported that regulatory T cells are dysfunctional in MS patients; therefore enhancing the regulatory T cell responses in MS is an attractive therapeutic target. Using the mouse model of MS, experimental autoimmune encephalomyelitis (EAE) we have attempted to develop disease-relevant Treg-based therapies to prevent disease induction. This required an understanding of the antigenic-reactivity of Tregs during disease. Results described in this thesis show that a proportion of Tregs in the draining lymph nodes and CNS were reactive to the disease initiating antigen(s) and could suppress in vitro responses of naïve T cells bearing transgenic T cell receptors, recognising the same antigen. Adoptive transfer of antigen-reactive Tregs suppressed disease induced with the same antigen, but also reduced disease induced with a distinct myelin antigen. Peptide-based tolerance using a high affinity MHC binding peptide analogue expanded and maintained antigen-reactive T cells which were tolerant to antigenic restimulation, although these cells did not express Foxp3. Peptide-treated mice showed reduced incidence of disease relapses during EAE induced against a distinct myelin antigen. Thus, while EAE and MS will involve a polyclonal effector T cell response to many antigens, therapeutic targeting of Tregs reactive against one CNS component may be sufficient to reduce disease. Endogenous expression of myelin autoantigen did not grossly alter the response of antigenreactive Tregs in the periphery. However, expression of endogenously derived viral superantigen enhanced the proportion of superantigen-reactive Foxp3+ Tregs in the periphery. This observation was extended using exogenous superantigen, suggesting that prolonged exposure to low dose (super)antigen tips the balance of the immune system in favour of regulation. This has implications for the ability to successfully fight infection, as well as for the limitation of autoaggressive responses and may contribute to the understanding of the hygiene hypothesis.
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Chabon, Joshua D. "Irrigation management effects on nitrate leaching and mowing requirements of tall fescue." Thesis, Kansas State University, 2014. http://hdl.handle.net/2097/17716.
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Master of ScienceDepartment of Horticulture, Forestry, and Recreation Resources
Dale J. Bremer
Jack D. Fry
Irrigation management may influence nitrate leaching under tall fescue (Festuca arundinacea) and also affect its mowing requirements. Two experiments were conducted on tall fescue growing on a Chase silt loam soil near Manhattan, Kansas. Each experiment was arranged in a split-plot design, with irrigation treatments applied to whole plots: 1) frequency-based irrigation, water was applied three times weekly to deliver a total of 19 mm water wk⁻¹ regardless of weather conditions; and 2) soil moisture sensor (SMS)--based irrigation, 34 mm of water was applied when soil dried to a predetermined threshold. In the first experiment, sub-plots consisted of unfertilized turf, and N applied as urea or polymer-coated urea at 122 and 244 kg ha⁻¹ yr⁻¹. Suction lysimeters at a 0.76 m depth were used to extract nitrate leachate bi-monthly. Turf quality was rated weekly. In the second experiment, subplots were mown at 5.1 cm or 8.9 cm, based upon the 1/3 rule, with or without monthly applications of the growth regulator trinexapac-ethyl (TE). Data were collected on total mowings and visual turf quality. Soil moisture sensor-based irrigation resulted in water savings of 32 to 70% compared to frequency-based irrigation. Leaching levels did not exceed 0.6 mg L⁻¹ and no differences in leaching were observed between irrigation treatments or among N sources. All fertilized turf had acceptable quality throughout the study. In the second experiment, irrigation strategy did not influence total number of mowings. In the first year, TE application reduced total mowings by 3 in tall fescue mowed at 5.1 cm, but only by 1.5 when mowed at 8.9 cm. In the second year, mowing at 8.9 vs. 5.1 cm or using TE vs. not resulted in a 9% reduction in total mowings each. The SMS-based irrigation saved significant amounts of water applied compared to frequency-based irrigation, while maintaining acceptable quality, but irrigation treatments did not affect nitrate leaching or mowing frequency in tall fescue on fine silt-loam soil. Nitrate leaching, regardless of amount, was well below the standards set for human health (10 mg L⁻¹). Applications of TE are more beneficial for turfgrass mowed at lower cutting heights.
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Carrenõ, Marcos Eric 1977. "International regulation of commercial civil aircraft : regulatory agencies and requirements governing large transport aircraft certification." Thesis, Massachusetts Institute of Technology, 2003. http://hdl.handle.net/1721.1/82770.
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Hataier, Maria. "How Higher Education Compliance Officers Learn to Manage New Requirements in a Dynamic Regulatory Environment." Thesis, Teachers College, Columbia University, 2018. http://pqdtopen.proquest.com/#viewpdf?dispub=10817413.
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As modern gender movements shift our cultural norms, the literature describing Title IX suggests possibly concerning trends in both hiring and policy. Many university administrations and recent legislation have promoted a defensive, legal-minded and objective approach to handling Title IX cases. Since the April 2011 Dear Colleague Letter, which delivered a mandated timeframe and eased the burden of evidence, the number of cases the Office for Civil Rights have grown significantly. The number of cases continues growing despite huge increases in labor hours and financial resources being diverted to Title IX enforcement. In contrast, research has demonstrated that education, such as bystander training is a proven deterrence to campus sexual assault. By prioritizing investigation and limiting compliance officers legally acceptable options, we have perhaps shifted officers time away from actions which might lead to more positive outcomes including reducing the overall campus-wide criminal incidence frequency.
This qualitative case study was designed to explore how higher education compliance officers learn to manage new requirements in a dynamic regulatory environment. The site for the study included private and public colleges and universities in the northeastern part of the U.S. The primary sources of data were in-depth interviews with nineteen Title IX compliance officers supplemented by an extensive review of relevant documents.
Key findings that emerged include: (1) A majority of compliance officers defined the need to interpret new regulations with general counsel before communicating resulting changes to stakeholders. (2) All regulators learn through informal learning means; dialogue and critical reflection were universally reported as the most frequent pathways by which regulators made meaning of new regulations. (3) Most compliance officers described sharing information with peers as most helpful to them in completing regulatory tasks.
Trends in Title IX compliance hiring and labor hour allocation appear to not address the growing frequency of OCR investigations. Real changes to campus policy, including budget priorities, training and the use of student activists may allow universities to better optimize the money and personal they invest toward Title IX.
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Holm, Jesper, and Emelie Bergström. "Does quantity matter? : An investigation of the quantity of information in risk reports effect on the financial performance of EU banks." Thesis, Umeå universitet, Företagsekonomi, 2014. http://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-91347.
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Banks within Europe have a major role in the European financial system. The financial collapse in 2008 made regulators well aware of the importance of corporate transparency to allow stakeholders to assess the banks health and maintain a stable market. Risk reporting within the European Union (EU) contributes to transparency in terms of disclosing information on risk management activities. The heavy regulations and demand from investors have caused the extent of risk reports to increase over time. The purpose of this research is to investigate if there is a relationship between the quantity of information in risk disclosures and the financial performance for banks in the EU and thus contribute with new knowledge to the field of finance, and increase managers' as well as stakeholders' understanding of the impact of risk reports. The methodological standpoints guide our choices throughout the research process. Our epistemological view is positivism and our ontological view is objectivism. A deductive research approach and a quantitative research method are adopted to collect archival data from risk reports and on financial performance from a sample of 41 banks. Our population consist of banks within the EU. The research design is cross-sectional using data from one point in time, the time period 2013-04-01 - 2014-03-31. Based on relevant theories and previous research, quantity proxies in terms of number of pages, words, characters and recurrence of keywords together with financial performance measures in terms of stock return, standard deviation and beta are used to investigate the relationship. 3 hypotheses are derived and tested by running regressions where the financial performance measures are the dependent variables and our proxies for quality are the independent variables. Our tests show that no significant relationship exists between the quantity of information in risk disclosures and the financial performance of banks within the EU. The results from our research contribute with new knowledge to academics within the field of finance by increasing the understanding of the explanatory variables for financial performance. Moreover, academics may use our results to justify the choice of other proxies than quantity when investigating quality in corporate disclosures. Additionally, our results indicate that practitioners should not use quantity of information in risk reports as an indicator of quality, as no relationship with the financial performance of a bank could be statistically proven.
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Duke, Janet School of Social Work UNSW. "Silent values : contextualising justice within the disjunctures between care discourses, regulatory requirements and nursing practice realities." Awarded by:University of New South Wales. School of Social Work, 2002. http://handle.unsw.edu.au/1959.4/19127.
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The notion of 'Care' has occupied a central place as foundation in nursing theory, ethics and practice. An examination of critical and authoritative documents reveals that the term is vague and ill defined. The literature on care does not theorise the concept as fully as expected in a profession where the concept is considered central. Moreover, even the best theories of care neglect justice. Applying Wittgenstein's concept of family resemblance allows the debate to move on from definitional issues to assess the applicability of 'care' to the practice of the profession. An examination of a range of assessments of nursing practice shows that although 'care' is frequently used in connection with nursing, it does not appear to be a major consideration in key areas of appraisal. This thesis explores the relationship between care and justice in nursing and proposes that they be integrated within nursing theory. A theory for nursing that does not exclude care, but that has justice as its basis is proposed. Care, when used in the context of justice provides nursing with a theory that is appropriate not only for nursing theory and ethics but also assists the profession meet the demands of modern practice.
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Joubert, Gerhardus Johan. "The impact of regulatory and statutory requirements on audit fees of JSE-listed companies / Gerhardus Johan Joubert." Thesis, North-West University, 2006. http://hdl.handle.net/10394/1475.
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Woodworth, Ashley. "Integration of Regulatory Requirements for the Creation of a Remediation Tool at the Portsmouth Gaseous Diffusion Plant." University of Cincinnati / OhioLINK, 2014. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1397233188.
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Ванько, В. М., and Н. М. Клепач. "Формування нових нормативних вимог щодо якості електроенергії у мережах загального призначення." Thesis, Сумський державний університет, 2016. http://essuir.sumdu.edu.ua/handle/123456789/48106.
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Електрична енергія (ЕЕ) слугує одним з важливих енергетичних ресурсів, що застосовується під час виконання різноманітних технологічних процесів у виробництві. Враховуючи масовий характер застосування, по відношенню до ЕЕ декларуються нормативні вимоги з якості, що наведені в [1]. Варто зазначити, що завдання забезпечення якості ЕЕ та гарантування її показників якості (ПЯ) в межах нормально і гранично допустимих значень є не лише технічною, але й нормативною проблемою, оскільки вимагає розвитку теорії вимірювання ПЯ ЕЕ та вдосконалення нормативних документів, котрі регламентують дані вимірювання.
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Muhammad, Ridzuan Mohd Ikhwan Bin. "Reliability assessment of distribution networks incorporating regulator requirements, generic network equivalents and smart grid functionalities." Thesis, University of Edinburgh, 2017. http://hdl.handle.net/1842/29009.
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Over the past decades, the concepts and methods for reliability assessment have evolved from analysing the ability of individual components to operate without faults and as intended during their lifetime, into the comprehensive approaches for evaluating various engineering strategies for system planning, operation and maintenance studies. The conventional reliability assessment procedures now receive different perspectives in different engineering applications and this thesis aims to improve existing approaches by incorporating in the analysis: a) a more detailed and accurate models of LV and MV networks and their reliability equivalents, which are important for the analysis of transmission and sub-transmission networks, b) the variations in characteristics and parameters of LV and MV networks in different areas, specified as “generic” UK/Scottish highly-urban, urban, sub-urban and rural network models, c) the relevant requirements for network reliability performance imposed by Regulators on network operators, d) the actual aggregate load profiles of supplied customers and their correlation with typical daily variations of fault probabilities and repair times of considered network components, and e) some of the expected “smart grid” functionalities, e.g., increased use of network automation and reconfiguration schemes, as well as the higher penetration levels of distributed generation/storage resources. The conventional reliability assessment procedures typically do not include, or only partially include the abovementioned important factors and aspects in the analysis. In order to demonstrate their importance, the analysis presented in the thesis implements both analytical and probabilistic reliability assessment methods in a number of scenarios and study cases with improved and more detailed “generic” LV and MV network models and their reliability equivalents. Their impact on network reliability performance is analysed and quantified in terms of the frequency and duration of long and short supply interruptions (SAIFI and SAIDI), as well as energy not supplied (ENS). This thesis addresses another important aspect of conventional approaches, which often, if not always, provide separate indicators for the assessment of system-based reliability performance and for the assessment of customer-based reliability performance. The presented analysis attempts to more closely relate system reliability performance indicators, which generally correspond to a fictitious “average customer”, to the actual “best-served” and “worst-served” customers in the considered networks. Here, it is shown that a more complex metric than individual reliability indicators should be used for the analysis, as there are different best-served and worst-served customers in terms of the frequency and duration of supply interruptions, as well as amounts of not supplied energy. Finally, the analysis in the thesis considers some aspects of the anticipated transformation of existing networks into the future smart grids, which effectively require to re-evaluate the ways in which network reliability is approached at both planning and operational stages. Smart grids will feature significantly higher penetration levels of variable renewable-based distributed generation technologies (with or without energy storage), as well as the increased operational flexibility, automation and remote control facilities. In this context, the thesis evaluates some of the considered smart grid capabilities and functionalities, showing that improved system reliability performance might result in a deterioration of power quality performance. This is illustrated through the analysis of applied automation, reconfiguration and automatic reclosing/remote switching schemes, which are shown to reduce frequency and duration of long supply interruptions, but will ultimately result in more frequent and/or longer voltage sags and short interruptions. Similarly, distributed generation/storage resources might have strong positive impact on system reliability performance through the reduced power flows in local networks and provision of alternative supply points, even allowing for a fully independent off-grid operation in microgrids, but this may also result in the reduced power quality levels within the microgrids, or elsewhere in the network, e.g. due to a higher number of switching transfers and transients.
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van, der Riet Estelle. "Evaluation of the level of compliance of Veterinary medicine package inserts with Regulatory authority guidelines." University of the Western Cape, 2021. http://hdl.handle.net/11394/8313.
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Magister Scientiae (Medical Bioscience) - MSc(MBS)Background: Veterinary medicines play an imperative role in the diagnosis, prevention and treatment of animal diseases. Many veterinary stock remedies in South Africa are available to the public without the intervention or supervision of a veterinarian or healthcare worker. Therefore, the accompanying package insert with product information and directions for use is central in promoting the safe and effective use of stock remedies. Information such as the dosage, warnings, precautions and storage instructions are essential to assist the user in their treatment decision-making. While local regulatory authority guidelines prescribe and control the minimum information that should be available in the package insert or product label, it is questioned whether the information contained in package inserts of products on the market complies with these regulatory requirements. Methodology: Using simple random sampling of veterinary stock remedies, 159 package inserts or product labels from various animal health companies were selected and evaluated against the prescribed labelling guidelines of the local regulatory authority responsible for the registration and control of stock remedies. The contents of each package insert or label in the sample were assessed for the presence of the prescribed information statements and were accordingly classified as non-compliant, partially compliant or compliant. Results: Among the 159 package inserts, 48 were for antimicrobials, 49 for ectoparasiticides, 44 for anthelmintics and the remaining 18 for endectocides. It was observed that none of the package inserts met all of the criteria and that the package inserts were inadequate in many aspects. The average percentage of compliance was 69.43%, with a range of 36.21% to 87.93%. Conclusion: The study indicated that many package inserts do not fully comply with the prescribed regulatory guidelines and that information related to the safe and appropriate use of stock remedies is insufficient.
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Girod, Alexandra. "Bank Risk Taking and Prudential Regulation : an Analysis of Impacts of Risk Sensitive Regulatory Capital Requirements on Bank Risk." Nice, 2011. http://www.theses.fr/2011NICE0019.
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J’étudie les mécanismes internes que la régulation de Bâle induit sur la prise de risque des banques, en particulier l’impact du ratio sensible au risque. La régulation se compose d’un ratio de capital et d’un cadre qui en assure le fonctionnement. La première partie porte sur le cadre. Les interactions entre la sensibilité au risque, la technicité et la délégation aux banques de l’estimation des inputs réglementaires posent deux nouveaux défis. En premier la technicité du cadre actuel peut induire en erreur les banques. En second le contrôle-délégué et la sensibilité au risque créent un dilemme incitant les banques à sous-estimer leur niveau de risque. Enfin la sensibilité au risque ne remet pas en cause l’intérêt de l’arbitrage réglementaire via la titrisation. La seconde partie se focalise sur le ratio sensible au risque. Je définis un cadre avec des actifs higher risk / higher returns, où le comportement de prise de risque consiste en un choix d’actif plus risqué. Je conclue que le ratio sensible au risque n’empêche pas un tel comportement. Ce ratio présente des variations marginales et cycliques qui altèrent le niveau de risque optimal de la banque. Le résultat principal est un effet pro-cyclique en termes de niveau de risque de l’actif : l’amélioration du cycle économique permet à la banque d’exploiter l’allégement de capital réglementaire (bonus réglementaire) pour accroitre sa valeur par le financement d’un actif plus risqué ; l’inverse se produit pendant une récession, la pénalité réglementaire restreint le niveau optimal de risque pour la banque. Cet effet est dû à la dépendance cyclique du ratio sensible au risqueI aim at studying internal mechanisms the Basel regulation induces on bank’s risk taking, particularly impacts of risk sensitive requirements. Actually regulation consists in a capital to asset ratio but also in a regulatory framework structuring its functioning. In a first part I concentrate on the structure. Interactions from risk sensitivity, technicality and delegation to banks of inputs' assessment raise two new challenges. First the high technicality of the current framework, with missing guidance for its implementation, can mislead bank's decision. Second delegated-control and risk sensitivity create a dilemma for banks that encourage them to understate their risk level. Moreover, risk sensitive requirements do not impact the rationale to entail regulatory arbitrages via securitisation process. In a second part I focus on risk sensitive requirements. I define a framework with higher risk / higher returns assets where a risk taking behaviour consists in a choice of a riskier asset. The analysis concludes the risk sensitivity does not prevent from the emergence of risk taking behaviour. The IRB risk weight function displays marginal and cyclical variations that impact bank's optimal risk level. My main result is a pro-cyclical effect in terms of asset's risk level: as the business cycle improves, the bank can exploit the freeing of regulatory capital (regulatory bonus) to foster its value towards the financing of a riskier asset; reverse happens for recession where the regulatory penalty restricts bank's optimal asset's risk level. This pro-cyclical effect is due to the cyclical dependence of risk sensitive requirements
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Santos, Maria Ana e. Castello-Branco dos. "Backtesting of a credit scoring system under the current regulatory framework." Master's thesis, Instituto Superior de Economia e Gestão, 2017. http://hdl.handle.net/10400.5/14152.
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Mestrado em Ciências ActuariaisDesde a implementação do atual acordo de supervisão financeira internacional, os bancos podem usar as suas estimativas internas de avaliação de risco de crédito como base para o cálculo dos ponderadores de risco e requisitos de capital. Consequentemente, com vista a assegurar a estabilidade e solvabilidade das instituições de crédito, torna-se crescente a necessidade de um sistema de validação robusto, para garantir a consistência e precisão dos sistemas de notação interna. Existem vários estudos sobre o processo de validação de estimativas internas. No entanto, aprofundamento e acordo nesta matéria são ainda insuficientes, nomeadamente no que diz respeito à avaliação da precisão das estimativas internas para os parâmetros de risco de crédito, com o objectivo de atingir a estabilidade dos requisitos de capital. A calibração das probabilidades de incumprimento representa um dos procedimentos de validação quantitativa inerentes ao exercício de backtesting. Neste trabalho, será explorado o processo de calibração das probabilidades de incumprimento recorrendo a um modelo de scoring para exemplificar como é feita a avaliação da capacidade preditiva destas estimativas internas numa carteira de Crédito à Habitação. Para superar o desafio de desenvolver um sistema de validação adequado, o presente projeto tem em consideração o atual e amplo quadro regulatório proveniente do Comité de Basileia para a Supervisão Bancária (BCBS) e da Autoridade Bancária Europeia (EBA), alguns artigos relevantes nesta matéria e aquelas que são consideradas as melhores práticas de gestão do risco de crédito.
Since the implementation of the current regulatory framework within the global financial system, banks are allowed to rely in a system using their own estimates for credit risk parameters as inputs for the calculation of risk weights and capital requirements. Consequently, in order to assure the stability and soundness of credit institutions, the need for a robust validation system to ensure accuracy and consistency of internal rating systems is greater than ever before. Although several studies on validation processes already exist, a deeper understanding and agreement on this subject is required, namely in what concerns the accuracy assessment of internal estimates for credit risk parameters, in order to achieve capital requirements stability. Calibration of default probabilities represents one of the quantitative validatio procedures underlying the exercise of backtesting that must be performed on a regular basis. The present text discusses the probability of default (PD) calibration process using a scoring model to illustrate the assessment of the predictive power of these internal estimates in a residential mortgage portfolio. To overcome the challenge of developing an adequate validation scheme in compliance with the current regulatory framework, this project project keeps in mind the legislation from Basel Committee on Banking Supervision (BCBS) and European Banking Authority (EBA), some relevant studies developed on this subject and those that are consider to be the best practices of credit risk management.
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Lützenkirchen, Kristina Alexandra [Verfasser]. "Adequacy of capital requirements for securitizations : financial engineering of regulatory approaches, cyclicality, systematic risk and rating standards / Kristina Alexandra Lützenkirchen." Hannover : Technische Informationsbibliothek und Universitätsbibliothek Hannover (TIB), 2014. http://d-nb.info/1065271026/34.
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Bartůsek, Michal. "A STUDY ASSESSING THE IMPACTS OF NEW REGULATORY PROPOSALS ON CYCLICALITY OF CAPITAL REQUIREMENTS: THE CASE OF THE CZECH REPUBLIC." Master's thesis, Vysoká škola ekonomická v Praze, 2011. http://www.nusl.cz/ntk/nusl-150306.
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This work focuses on new regulatory proposals, primarily Basel III accords and analyzes its ability to create a buffer for recurrent credit bubbles. This paper follows a research made by Lis, Pagés and Saurina [2000]. Their paper has illustrated the cyclicality of loan growth and GDP growth for Spain. This cyclicality is supported by cyclical Basel II regulation. In this paper is examined the ability of new regulatory proposals such as Basel III, statistical provisions and change in the approach to the probability of default, to cope with recurrent credit bubbles. According to my critical assessment, Basel III may not be able to create sufficient capital buffer for exceptional credit bubbles such as the current one. This buffer suggested by Basel III has several drawbacks which may decrease its functionality. Statistical provision is not an appropriate measure either, because it could weaken the fair and true view of financial statements principle. Change in approach to probability of default seems to be rational and effective. The only issue may relate to its recovery mechanisms. It doesn't support economic growth in time of economic recession. The author's proposal of new countercyclical buffer, which would be based on credit-to-GDP ratio and GDP growth to loan growth gap is introduced at the end of this work. Although this measure may have negative impact on GDP growth, it may create an appropriate buffer to systematic credit risk.
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Othman, Abdullah. "Exploring the business benefits of regulatory compliance : the case of AML/CFT systems for banking institutions in Malaysia." Thesis, Loughborough University, 2013. https://dspace.lboro.ac.uk/2134/12362.
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It has been widely accepted that the banking industry is highly dependent on information technology (IT). Due to its pervasiveness and intertwining nature in most aspects of banking business, IT has also significantly become one of the critical components that facilitate the ability of banking institutions to meet regulatory requirements in an efficient and a cost-effective way. For instance, in the effort to mitigate the activities of money laundering and terrorism financing (ML/TF), various information on banking customers are timely and accurately gathered and analysed through automation. Furthermore, in many instances, IT systems exclusively built to achieve a similar objective are frequently established, and comparable to most IT implementations in the banking institutions, they are often can be equally regarded as a significant investment as well. Viewed from the longstanding debate on the value of IT investments to organisations, empirical research within the IS domain seemed to have placed less emphasis on the possible contribution of regulatory IT implementations. While it is easy to conceive that these IT deployments were never intended to directly benefit banking business from the outset, a study from this perspective should not be disregarded, but instead, warrant to be equally explored. The rationale for this statement can be attributed to the aforementioned assertion regarding the potentially substantial monetary investments required. In addition to this, it may also be due to the high tendency of stringent regulations being enforced in the future, and hence, could inevitably place a significant demand on organisational resources, and further influence their associated opportunity costs. For that reason, this study has attempted to fill the identified research gaps by conducting an investigation from the standpoint of a topical issue regarding anti-money laundering and counter terrorism financing (AML/CFT) implementation efforts within banking institutions. Utilising a conceptual framework that leverages the resource-based view (RBV) to structurally analyse a list of research objectives, empirical evidence of business benefits and the associated capabilities through organisational AML/CFT efforts have indeed been discovered. The benefits are particularly in the form of having the opportunity to leverage various information and infrastructure that were established for regulatory purposes. Further evidence has also suggested that selected AML/CFT alerts have the potential of providing unique opportunity for the organisation to trigger time-critical event-based marketing activities, resulting in a possible improved competitive positioning (ICP). Importantly, by appreciating the insights obtained through the research, a conceptual framework is proposed, which may aid to structurally assess the possible benefits of any organisational regulatory IT implementations.
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Ludwig, Alexander. "The new regulatory regime for European insurers - expected impact on insurers’ investment decisions and a critical assessment of its solvency capital requirements." Doctoral thesis, Saechsische Landesbibliothek- Staats- und Universitaetsbibliothek Dresden, 2015. http://nbn-resolving.de/urn:nbn:de:bsz:14-qucosa-171601.
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Under the current regulatory regime for insurance undertakings, Solvency I, the required capital margin does not depend on the allocation of investments, i.e. it is not sensitive to market risk arising from the volatility of market prices for e.g. equity, bond or real estate investments.
To improve the protection of policyholders and create a unified regulatory regime in all countries of the European Economic Area (EEA), a risk-sensitive, forward-looking and principle-based regulatory accord for insurance undertakings called Solvency II will replace the current regime by 01.01.2016. Unlike Solvency I, Solvency II requires the backing up of any investment in risky assets with risk capital rather than imposing investment limits. Own funds eligible to cover the solvency capital requirements under Solvency II shall be based on the difference of market-consistently valuated assets and liabilities in the Solvency II balance sheet.
In this thesis, I first summarize academic contributions as well as opinions from industry representatives on the expected consequences of the current calibration of the Solvency II standard formula. The accuracy of the calibration itself is another focal point of this work.
This work contains four scientific papers. The first paper examines the presence of contagion effects between Eurozone countries in the period 2008-2012. In a market-consistent valuation approach like Solvency II contagion effects intensify the volatility of own funds and therefore of the solvency ratio of insurers. The intensity of contagion peaked in 2010 and first half of 2011 but decreased subsequently which is likely to be a consequence of bailout measures by the EU and the IMF and ECB interventions.
The second and third paper address the zero risk charge for sovereign debt issued by EU member states assumed under the Solvency II standard formula. If one accepts German bond yields to be a risk-free asset, using modern cointegration techniques I showed that bonds of only one third of EU member countries can be perceived as risk-free as well. The fourth paper provides evidence for convergence in the shock-response-behavior of the stock indices of Germany, UK and France during the past decades, which in turn indicates support for the assumption of a perfect tail correlation between listed equity in the Solvency II standard formula.
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Hoey, Barbara. "A Comprehensive Study on the Global Regulatory Requirements for the submission of a Post-Approval Change, specifically a Change in Manufacturing Site." University of the Western Cape, 2017. http://hdl.handle.net/11394/6128.
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Magister Scientiae - MSc (Pharmacy Administration and Policy Regulation)Regulatory requirements for post-approval changes vary for different countries around the world. It is a challenging and costly process for pharmaceutical companies to manage changes to the approved regulatory dossier over the lifecycle of the product when it is registered in many countries. In practice the process can be complex, unpredictable and time consuming because of regional differences and frequent changes in regulatory procedures, requirements and timelines. The global regulatory requirements for the submission of a post-approval change, specifically a change in manufacturing site, were reviewed for six jurisdictions for this study. These include United States of America (US), Europe (EU), South Africa, Brazil, Russia and China. The study centred on the differences in the documentation required when submitting a post-approval change for a change in manufacturing site in these countries. The study compared and contrasted the differences and similarities between the jurisdictions. An analysis of the challenges for implementation of the change was performed. The study also examined what resources a company may need in order to meet the requirements. Some notable similarities but also many differences in the post-approval submission requirements between the countries were identified. Some of the similarities included classification of the type of variation, the submission application process, and the requirement to provide supportive stability data and updates to the common technical dossier (CTD). Differences highlighted were the types of application forms required, the amount of stability data required to support the change and the time lines for review of post-approval changes in each jurisdiction. The challenge for pharmaceutical companies arises in the effective management of these differences. Investment in a robust regulatory change management team is an essential resource requirement for pharmaceutical companies. Adoption of a QbD approach and careful consideration of the global requirements during the product development phase could potentially be of use in strategic planning within a company in order to ensure continued product access globally.
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Pětníková, Tereza. "Řízení kreditního rizika v bankách." Master's thesis, Vysoká škola ekonomická v Praze, 2014. http://www.nusl.cz/ntk/nusl-206735.
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The subject of this diploma thesis is managing credit risk in banks, as the most significant risk faced by banks. The aim of this work is to define the basic techniques, tools and methods that are used by banks to manage credit risk. The first part of this work focuses on defining these procedures and describes the entire process of credit risk management, from the definition of credit risk, describing credit strategy and policy, organizational structure, defining the most used credit risk mitigation tools to the regulatory requirements for credit risk management. The second part gives a more detailed view to credit risk measurement and evaluation and possibilities of credit risk hedging. Last part presents credit risk management in practise illustrated by the example of chosen bank.
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Ramalho, Bruno Araujo. "Processo decisório e motivação no âmbito das normas sobre o 'rol de procedimentos e eventos em saúde': uma análise exploratória." reponame:Repositório Institucional do FGV, 2017. http://hdl.handle.net/10438/18085.
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Procedural requirements related to decision making and justification of regulatory choices may have limited application under uncertainty, informational limitation and other obstacles that lead the regulator to adopt strategies to tailor decision making to reality. Based on this hypothesis, and considering the uncertainties and issues of high technical complexity related to the 'list of health care procedures and events in health care', the objective of the research was to carry out an exploratory analysis intended to identify limitations, obstacles and observable strategies in the elaboration and justification of these norms. For this purpose, it was adopt a methodology of qualitative analysis based on documentary research, which included different documents available through the National Regulatory Agency for Private Health Insurance and Plans (ANS) website in public consultations, in the Technical Group for reviewing the list of procedures and in the Committee on Regulation of Health Care (COSAÚDE). As a result, it was verified the hypothesis mentioned above, since the dynamics of the choice presents restrictions that lead the regulator to adopt different strategies to deal with. The obstacles related to 'decision-making' dimension arise from the complexity and uncertainties related to the medical evidences, informational limitations and from interferences of the Legislative Branch and the Judiciary. Regarding the giving reasons requirement, although it is possible to see a greater density of justification starting in 2013, the reasons and replies presented in a synthesized format often do not suffice to clarify all the issues that support complex choices. Among the proposals of the study, the regulator should to provide a more detailed record about the valuation and the operationalization of its methodology criteria.
Exigências procedimentais relacionadas ao processo decisório e à justificação de escolhas regulatórias podem ter sua aplicação limitada em cenários de incerteza, limitação informacional e demais obstáculos que levam o regulador a adotar estratégias para adequar a tomada de decisão aos recursos disponíveis. Partindo-se desta hipótese, a pesquisa teve por objetivo a realização de uma análise exploratória com vistas a identificar limitações, obstáculos e estratégias observáveis na elaboração e justificação do rol de procedimentos e eventos em saúde – eis que a elaboração do 'rol' é permeada por incertezas e por questões de alta complexidade técnica. Para tanto, adotou-se a metodologia de análise qualitativa baseada em pesquisa documental, que englobou diferentes anexos disponibilizados a partir do sítio eletrônico da Agência Nacional de Saúde Suplementar (ANS) em consultas públicas, no Grupo Técnico de revisão do rol de procedimentos e no Comitê Permanente de Regulação da Atenção à Saúde (COSAÚDE). Ao final, foi possível evidenciar importantes elementos que moldam ou restringem a tomada de decisão e a sua respectiva justificação. No âmbito dos resultados, os obstáculos relacionados à dimensão 'processo decisório' decorrem de diferentes fontes de incerteza, do volume (e complexidade) das informações e de interferências promovidas pelo Poder Legislativo e Judiciário – sendo observáveis diferentes providências do regulador para cada caso. No que tange ao dever de motivação, embora se percebam melhorias a partir de 2013, a apresentação de justificativas e réplicas segue um formato mais compactado e não contempla algumas questões metodológicas que servem como base para premissas elencadas pelo regulador. Dentre outras propostas do estudo, sugeriu-se que a agência disponibilize o amplo acesso a documentos ou relatórios que registrem, de forma pormenorizada, a operacionalização dos quesitos que integram a metodologia de decisão.
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Hashmi, Mustafa. "Evaluating business process compliance management frameworks." Thesis, Queensland University of Technology, 2015. https://eprints.qut.edu.au/91220/1/Mustafa_Hashmi_Thesis.pdf.
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This research contributes a formal framework to evaluate whether existing CMFs can model and reason about various types of normative requirements. The framework can be used to determine the level of coverage of concepts provided by CMFs, establish mappings between CMF languages and the semantics for the normative concepts and evaluate the suitability of a CMF for issuing a certification of compliance. The developed framework is independent of any specific formalism and it has been formally defined and validated through the examples of such mappings of CMFs.
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Hellou, Samira. "Réglementations de Bâle et flux de capitaux bancaires vers les pays émergents." Thesis, Paris 10, 2018. http://www.theses.fr/2018PA100025/document.
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Le monde économique connaît actuellement un large mouvement de réglementation afin de stabiliser la finance et de renforcer la surveillance des activités bancaires à travers le nouveau dispositif de Bâle. Ce dernier est au centre du débat actuel sur les besoins de financement de l’économie dans le cadre de la crise actuelle et ses effets sur le financement de l’économie. En effet, les pays développés ont connu un credit crunch à la suite de la crise des subprimes et du renforcement de la réglementation des activités bancaires. Dans ce cadre, nous nous intéressons aux effets du nouveau cadre réglementaire et de son application dans les pays développés, où sont implantées les banques internationales, sur leurs flux bancaires vers les pays émergents qui ont déjà connu de grandes crises dues à la nature volatile de leur financement extérieur. Les résultats apportés dans le cadre de cette thèse montrent que la réglementation basée sur les pondérations aux risques affecte le volume, la structure et la volatilité de ces flux. En effet, vu l’importance des flux bancaires dans le financement des pays émergents et vu le renforcement des exigences réglementaires dans le contexte de la crise, la modification des possibilités d’arbitrage réglementaire a conduit à des modifications de la structure du financement externe des pays émergents avec la progression du financement obligataire au détriment du financement bancaire. Cette nouvelle structure, volatile et dépendant des cycles de marché, n’est pas sans conséquences sur la stabilité financière de ces pays trop sensible aux changements de financement externe, ce qui implique de nouveaux défis pour garantir la stabilité de ces pays émergentsThe economic world is now undergoing a large regulatory movement to stabilize finance and strengthen the supervision of banking activities through the new Basel agreement. This agreement is the focus of the current debate on the economy financing needs in the context of the recent crisis and its effects on the economy financing. Indeed, developed countries have recently experienced a credit crunch following the subprime crisis and strengthening the regulation of banking activities. In this context, we are interested in the effects of the new regulatory framework and its application in developed countries, where are headquarters of international banks, on their banking flows to emerging countries that have already experienced major crises due to the volatile nature of external financing. The results obtained in this thesis show that regulation based on risk weights affects the volume, structure and volatility of these flows. Indeed, given the importance of bank flows in the financing of emerging countries and given the strengthening of regulatory requirements in the context of the crisis, the change in regulatory arbitrage opportunities modifies the external financing structure of emerging countries with the evolution of bond financing instead of bank financing. This new external financing structure, volatile and depends on market cycles, is not without consequences for the financial stability of these countries, which remains very sensitive to changes in external financing, what implies new challenges to guarantee their stability
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Stensson, Sofia. "Energy Efficiency in Shopping Malls : Some Aspects Based on a Case Study." Doctoral thesis, Chalmers, Gothenburg, Sweden, 2014. http://urn.kb.se/resolve?urn=urn:nbn:se:ri:diva-30079.
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The building sector accounts for approximately 40 percent of our energy use. To reach existing environmental targets energy use will have to be reduced in all building types. At the European level, the main legislative instrument for improving the energy efficiency of the building stock is the Energy Performance of Buildings Directive (EPBD). The EPBD requires all member states to implement the directive in the building code and it also requires energy declarations to be performed at the building level. The first objective of this thesis is to describe energy use in shopping malls in Sweden and to suggest how this energy use can be reduced. The second objective is to determine whether current regulatory requirements are effective in promoting energy efficiency measures in Swedish shopping malls. Only limited background information was found from national energy statistics and scientific papers that deal specifically with energy use in shopping malls. The data available are difficult to analyse and compare due to inconsistencies in terminology regarding nomenclature and system boundaries. An improved terminology is presented in the thesis, with a distinction between organisationally and functionally divided energy, to facilitate future studies. Furthermore, when it comes to designing shopping malls and evaluating their energy use, correct input data are required. For calculations and simulations of energy demand in buildings, internal and external load patterns are important input data. The thesis provides occupancy, lighting and infiltration load data for shopping malls. Energy use in one shopping mall was investigated in detail and resulted in a validated calculation model for the prediction of energy use. To develop the calculation model an iterative empirical-theoretical methodology was used. It involved cross-checking measured data, assumptions related to operational and technical data, and model calculation results. The calculation model was then used for a more general analysis of energy efficiency measures and an evaluation of regulatory requirements. The thesis illustrates how the current building code and energy declarations are implemented in shopping malls today together with associated strengths and weaknesses.
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TYMBIOS, Joanna Antonia. "An evaluation of western herbal complementary medicine labelling in South Africa, to determine whether the product labelling information complies with established herbal monographs and whether it meets local regulatory requirements." University of the Western Cape, 2015. http://hdl.handle.net/11394/5111.
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Magister Pharmaceuticae - MPharmMedicines (CMs) are widely available to the South African public. However, CMs have not yet been evaluated by the Medicines Control Council (MCC). The MCC has published new guidelines for the regulation of CMs, with which CM companies are required to comply. OBJECTIVE: Determine to what degree Western Herbal CM labelling complies with the MCC’s requirements. METHODS: Thirteen CM products containing recognised Western Herbal ingredients were selected from pharmacies in the northern suburbs of Johannesburg. Labelling information on the immediate and outer container labels, as well as the package inserts, was investigated. The relevant corresponding European Medicines Agency (EMA) monographs and MCC guidelines were used to assess compliance. RESULTS: None of the products complied with the product dosage section of the monographs. Furthermore, the products contained indications that were not present in the monographs. The products did not fully meet the MCC’s mandatory minimum labelling requirements, and they did not demonstrate total compliance with all of the MCC’s requirements for product labels and package inserts.
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Nyaki, Judith V. "A critical analysis of Tanzanian corporate governance regulation and its impact on foreign investment." Thesis, University of Western Cape, 2013. http://hdl.handle.net/11394/3326.
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Magister Legum - LLMThe main objective of this study is to review the legal and regulatory framework of corporate governance in Tanzania with the focus on corporate governance laws and regulations. The study is intended to discuss the main legal and regulatory framework in Tanzania which plays a part in the corporate governance. The Companies Act No. 12 of 2002 will be reviewed in order to establish which corporate governance principles are provided and to what extent they are effective. The capital markets and securities laws, guidelines on corporate governance in Tanzania with a focus on the listing requirements and other regulations applied at the DSE will also be reviewed in order to establish their effectiveness in attracting investors to the market. Given the comparative value of South Africa and Kenya in SADC and EAC respectively, this work will also discuss the legal and regulatory framework of corporate governance in Kenya and South Africa and compare with those in Tanzania in areas such as shareholders rights; stakeholder’s right; board control and effectiveness and the effectiveness of compliance. Such comparative analysis is done in order to single out areas of focus in legal and regulatory framework in corporate governance law such as companies’ law and stock market and security laws in Tanzania.
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Ludwig, Alexander [Verfasser], Alexander [Akademischer Betreuer] Karmann, and Alexander [Akademischer Betreuer] Kemnitz. "The new regulatory regime for European insurers - expected impact on insurers’ investment decisions and a critical assessment of its solvency capital requirements / Alexander Ludwig. Gutachter: Alexander Karmann ; Alexander Kemnitz. Betreuer: Alexander Karmann." Dresden : Saechsische Landesbibliothek- Staats- und Universitaetsbibliothek Dresden, 2015. http://d-nb.info/1073207099/34.
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Albert, Nick William. "Two novel MYB transcriptional activators regulate floral and vegetative anthocyanin pigmentation patterns in Petunia : [a thesis presented in partial fulfilment of the requirements for the degree of Doctor of Philosophy in Plant Molecular Biology at Massey University, Palmerston North, New Zealand] EMBARGOED UNTIL 12 MARCH 2012." Massey University, 2009. http://hdl.handle.net/10179/1347.
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Mr Albert investigated the genetic mechanisms controlling complex floral and vegetative pigmentation patterns in Petunia. He discovered two new MYB transcription factors that control the timing and spatial location of anthocyanin pigment production in flowers and leaves, giving rise to specific colour patterns. He showed that complex pigmentation patterns are formed by tightly controlling the expression of genes required to synthesise anthocyanin pigments and involves proteins that both activate genes and repress them from being expressed. The interactions between distinct classes of transcription factors form an intricate network and hierarchy, allowing fine control of gene expression and strict control of pigment production. These findings will aid in the development of ornamental plants with new pigmentation patterns and also this research serves as a model for how plants control the expression of genes to produce health-promoting plant compounds.
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Havlíček, Radek. "Vliv Basel III na řízení rizik v bankách." Master's thesis, Vysoká škola ekonomická v Praze, 2016. http://www.nusl.cz/ntk/nusl-264647.
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The diploma thesis focuses on the regulatory framework of the BASEL III in coherence with risk management and measurement of market and credit risks. The accent is focused upon methodology of calculation and determination of the capital requirements of above mentioned risks. In the introductory part of the thesis are mentioned basic procedures regarding risk management as well as theoretical methodology and development of calculation of the capital requirements in coherence with current standard BASEL III. In the practical part of the thesis are presented capital management policies with regards to BASEL III in Deutsche Bank AG, globally presented institution and Komerční banka, a.s., operating on the Czech market. Accented are mainly the expositions of the institutions and the size of the capital required by the regulatory framework.
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Schulzensohn, Marlene [Verfasser]. "Biologicals and Biosimilars : Differences and implementation of the regulatory requirements in the European Union versus those in the United States with special consideration and analysis of the implementation and improvement of safety standards for biosimilar products / Marlene Schulzensohn." Bonn : Universitäts- und Landesbibliothek Bonn, 2018. http://d-nb.info/1161462228/34.
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Garner, Gary Owen. "An analysis of holding cost impact on housing affordability in relation to midsized Greenfield residential property developments in South East Queensland." Thesis, Queensland University of Technology, 2012. https://eprints.qut.edu.au/50957/1/Gary_Garner_Thesis.pdf.
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The position of housing demand and supply is not consistent. The Australian situation counters the experience demonstrated in many other parts of the world in the aftermath of the Global Financial Crisis, with residential housing prices proving particularly resilient. A seemingly inexorable housing demand remains a critical issue affecting the socio-economic landscape. Underpinned by high levels of population growth fuelled by immigration, and further buoyed by sustained historically low interest rates, increasing income levels, and increased government assistance for first home buyers, this strong housing demand level ensures problems related to housing affordability continue almost unabated. A significant, but less visible factor impacting housing affordability relates to holding costs. Although only one contributor in the housing affordability matrix, the nature and extent of holding cost impact requires elucidation: for example, the computation and methodology behind the calculation of holding costs varies widely - and in some instances completely ignored. In addition, ambiguity exists in terms of the inclusion of various elements that comprise holding costs, thereby affecting the assessment of their relative contribution. Such anomalies may be explained by considering that assessment is conducted over time in an ever-changing environment. A strong relationship with opportunity cost - in turn dependant inter alia upon prevailing inflation and / or interest rates - adds further complexity. By extending research in the general area of housing affordability, this thesis seeks to provide a detailed investigation of those elements related to holding costs specifically in the context of midsized (i.e. between 15-200 lots) greenfield residential property developments in South East Queensland. With the dimensions of holding costs and their influence over housing affordability determined, the null hypothesis H0 that holding costs are not passed on can be addressed. Arriving at these conclusions involves the development of robust economic and econometric models which seek to clarify the componentry impacts of holding cost elements. An explanatory sequential design research methodology has been adopted, whereby the compilation and analysis of quantitative data and the development of an economic model is informed by the subsequent collection and analysis of primarily qualitative data derived from surveying development related organisations. Ultimately, there are significant policy implications in relation to the framework used in Australian jurisdictions that promote, retain, or otherwise maximise, the opportunities for affordable housing.
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Childerhouse, Emma. "The effect of a natural plant extract and synthetic plant growth regulators on growth, quality and endogenous hormones of Actinidia chinensis and Actinidia deliciosa fruit : a thesis presented in partial fulfilment of the requirements for the degree of Master of Science in Horticultural Science at Massey University, New Zealand." Massey University, 2009. http://hdl.handle.net/10179/1052.
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Kiwifruit are of huge economic importance for New Zealand representing 29 percent of total horticultural exports. Fruit size is the biggest determinant of what consumers are willing to pay, and there is also a positive relationship between consumer preference for flavour and percentage dry matter. The two main cultivars exported from New Zealand are Actinidia chinensis ‘Hort 16A’ (gold kiwifruit) and A. deliciosa ‘Hayward’ (green kiwifruit). Under current commercial practice the only product allowed for use on kiwifruit to increase fruit size in New Zealand is Benefit®. Benefit® has been shown to induce different results when applied to A. chinensis and A. deliciosa, whereas synthetic plant growth regulators such as the cytokinin-like substance N-(2- chloro-4-pyridyl)-N’-phenylurea (CPPU) have been found to promote similar increases in fresh weight of fruit in both cultivars. Final fruit size is determined by both cell division and cell enlargement. It was been shown that fresh weight can be increased in both of the major Actinidia cultivars even though their physiology differs. Hormonal control of fruit size in relation to cell division and cell enlargement phases of fruit growth was studied in both A. chinensis and A. deliciosa. CPPU was applied to both cultivars in a growth response experiment where fruit were collected throughout the growing season. The objective of this experiment was to create growth curves, to compare and contrast the effect on A. chinensis and A. deliciosa, and to provide material for hormone analysis. Application of CPPU was found to significantly increase the fresh weight of both A. chinensis and A. deliciosa fruit (46.98 and 31.34 g increases respectively), and alter the ratio of inner and outer pericarps of A. chinensis fruit. CPPU and Benefit® were applied individually and together to both cultivars. It was found that only A. chinesis fruit were affected by the application of Benefit®; fresh weight was increased by 26.38 g, and percentage dry matter was significantly reduced. There was a statistically significant (p < 0.05) interaction between CPPU and Benefit® when applied to A. chinensis. 3,5,6-trichloro-2-pyridyloxyacetic acid (3,5,6-TPA) was applied to A. deliciosa on two application dates at three concentrations and was found to decrease fresh weight of fruit, but significantly increase percentage dry matter regardless of application date or concentration. Lastly CPPU and 1-naphthalene acetic acid (NAA) were applied to A. deliciosa at two application dates and in all combinations. Application date affected the response to both a low concentration of CPPU and NAA. A synergistic interaction was observed when CPPU was applied early plus NAA late (CPPU early (4.53 g increase) plus NAA late (13.29 g) < CPPU early plus NAA late (33.85 g). Finally endogenous hormone content was studied. Methods were developed and tested for the simultaneous analysis of both indole-3-acetic acid (IAA) and cytokinins. Freeze dried fruit were purified using Waters Sep-pak® cartridges and Oasis® columns then IAA was quantified by high pressure liquid chromatography. Preliminary results indicate a correlation between application of CPPU and endogenous IAA, high concentrations of IAA correlated well with periods of rapid fruit growth particularly for CPPU treated fruit.
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Pejanovic, Trivko. "Information management : best practices in broad base industries / Trivko Pejanovic." Thesis, North-West University, 2006. http://hdl.handle.net/10394/1564.
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Cooper, Melissa Kaye. "Australian Regulatory Requirements for Migration and Registration of Internationally Qualified Health Practitioners." Thesis, 2020. http://hdl.handle.net/2440/130112.
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Internationally qualified health practitioners (IQHP) seeking to live and work in Australia are required to obtain the appropriate skilled migration visa through an assessment by the Department of Home Affairs and the approved assessing authority and registration by the relevant health practitioner board. Regulators create policy frameworks, standards and assessment models to meet the requirements of the Health Practitioner Regulation National Law (as in force in each state and territory) and the legislation governing Australia’s General Skilled Migration program.
This research investigated the current policies and processes governing skilled migration and registration for internationally qualified nurses, midwives and doctors in Australia. The study was informed by rich qualitative data extracted from 28 in-depth semi-structured participant interviews. Shared experiences were mapped and examined for four key participant groups: assessors operationalising the current policies and processes governing skilled migration and registration; educators offering preparatory and training programs to IQHP; workforce agencies engaging with and recruiting IQHP; and internationally qualified doctors, nurses and midwives from across the globe.
Key themes and points of intersection between the participants’ experiences and the regulatory frameworks were identified using theory and data-driven coding and thematic analysis via NVivo 12 plus software. The findings were presented in three papers. Paper one, a policy perspective, examined current views, regulatory reviews and overall governance of skilled migration and registration of IQHP in Australia. Paper two, a case study, presented key themes and points of intersection identified between regulatory frameworks and shared experiences of 28 research participants separated into four discrete groups. The final paper presented the lived experiences of the second participant group, 15 IQHP, who described their complex, culturally challenging and costly journeys seeking their shared dream of living and working in Australia.
The research provides information and recommendations to assist regulators in ensuring that the standards, policy frameworks and organisational processes used to assess the suitability of IQHP for skilled migration and entry onto the Australian health practitioners register and ultimately into the health workforce are fair, transparent, consistent, equitable and robust, and assist in ensuring IQHP demonstrate the necessary qualifications and experience for protection of the Australian public. It is clear from the research that further exploration and more innovative and evidence-based solutions are required to support and reform the standards, guidelines and policy which are used to regulate and assess IQHP.Thesis (Ph.D.) -- University of Adelaide, Adelaide Nursing School, 2020
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Tyler, JV. "Regulatory requirements and board composition." Thesis, 2010. http://hdl.handle.net/10453/35602.
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University of Technology, Sydney. Faculty of Business.This thesis addresses the research question of regulatory requirements and board composition. Specifically it has two objectives: first, to provide evidence of the impact of the Principles of Good Corporate Governance and Best Practice (PGCG&BP) introduction in 2003 by the Australian Stock Exchange (ASX) on board composition. Second, to examine the association between board composition and continuous disclosure as a measure of governance effectiveness. Two of the main principles of the PGCG&BP were independent boards and greater accountability, and Australia provides a unique institutional setting to test accountability with the Continuous Disclosure Regime (CDR) because of the single portal announcement repository and the almost universal single topic announcements. This latter feature removes the confounding effect found in many other studies using annual reports. From a sample of 450 firms in 2001 and 2007, I find the number of firms with (majority) independent boards and committees increased following the PGCG&BP regulation (substantially in the case of the nomination committee), however the percentage of independent directors on boards increased only marginally, with firms that initially had a high percentage of independent directors often reducing their level of independence (mean reversion). Using ordinary least squares regression (OLS) I find the relation between board composition and firm characteristics reduced after the introduction of the regulation, adding weight to the proposition that boards were forced to become less ‘efficient’ or ‘optimal’. Further testing with OLS and two-stage least squares regression to control for potential endogeneity issues finds more independent boards do not appear to be associated with more continuous disclosures but the association is significant with other corporate governance factors. These results bring into question some of the expected outcomes of this corporate governance regulation.
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Toupin, Justin. "On the Minimization of Regulatory Margin Requirements for Portfolios of Financial Securities." Thesis, 2010. http://hdl.handle.net/1807/25825.
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A margin account is a type of brokerage account that allows investors to buy and sell financial securities using credit. The account’s margin requirement is the amount of collateral required, from the investor, to cover the funds or securities extended by the broker to the investor. In Canada, the primary driver of an account’s margin requirement is the account’s Capital Charge [CC] which is calculated using a set of regulatory rules. The regulations are degenerate in that hundreds of valid CCs often exist for a single account. This work outlines a linear optimization model for selecting the minimal CC out of the set of valid CCs for a given margin account. The method proposed is consistent with all of the regulatory requirements and is guaranteed optimal in most cases. Relative to existing methods, the new method produced an average CC reduction of approximately 2% and displayed qualitatively better run-times.
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Moonsamy, Marlene Rose. "Correlation between tertiary education and pharmaceutical industry requirements for regulatory affairs pharmacists." Thesis, 2016. http://hdl.handle.net/10539/21549.
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A Research Report submitted to the Faculty of Health Sciences, University of Witwatersrand,
Johannesburg, in fulfilment of the requirements for the degree of Master of Science in Medicine
Pharmacotherapy
June 2016In the pharmaceutical sector, the health of the public is protected by medicines regulatory authorities who enforce regulatory practices to be executed by pharmaceutical companies. In South Africa, the Medicines Control Council (MCC) describes these practice requirements via guidelines, which are based on the Medicines and Related Substances Control Act 101 of 1965. The Regulatory Affairs Department is often the first point of contact between the regulatory authority and the company. Regulatory affairs pharmacists therefore require broader skill sets than scientific and technical skills. Global expansion of regulatory affairs has resulted in significant skills shortage, for which a lack of education in regulatory affairs is partially responsible. Lack of communication between academia and industry further contributes to this skills shortage. In South Africa, the Pharmacy School curricula are approved by the South African Pharmacy Council (SAPC) in keeping with The Pharmacy Act 53 of 1974. Regulatory practices however, are determined by the Medicines and Related Substances Control Act. The aim of this study was to assess if there are inconsistencies in regulatory affairs between the pharmacy curriculum and job descriptions of regulatory affairs pharmacists, and to determine if graduating pharmacists entering industrial pharmacy are equipped for their role in regulatory affairs. The objectives were to examine regulatory education and regulatory practices in industry to assess deficiencies in the required competencies of a regulatory affairs pharmacist. The appropriate sections in Pharmacy curricula from all eight Pharmacy Schools in South Africa were examined to assess the level to which regulatory affairs is taught, and the job descriptions of regulatory affairs pharmacists were examined to assess the functional competencies required. Survey studies were conducted in the Pharmacy Schools and Pharmaceutical Industry to understand the gaps between what is taught and what is required in industry practice. The results showed that B.Pharm undergraduates were insufficiently prepared for their role in regulatory affairs, once they entered the Pharmaceutical Industry sector. Regulatory Affairs education is covered partially at undergraduate level but in some detail at a post-graduate level, in some Pharmacy Schools. Improvements are required to the current B.Pharm curricula, taking into account the Medicines Act 101 of 1965 and with MCC Guidelines, to accommodate regulatory affairs education. Collaboration between academia and industry has been proposed and employed in other countries and have been shown to be successful, hence this is also recommended for South Africa with most participants expressing a willingness to do so..
MB2016
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Khoza, Mpucuko Armstrong Ezekiel. "An empirical analysis of bank performance and regulatory requirements in South Africa." Diss., 2020. http://hdl.handle.net/10500/27028.
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This study examined the nexus between bank performance and regulatory requirements in South Africa. The panel regression approach was used, which applied panel data from 12 banks that were registered in terms of the Bank Act 94 of 1990 over the period 2009 to 2019. A quantitative research approach was used to investigate the nexus between bank performance, bank regulations, bank-specific factors and some macroeconomic factors. A regression analysis was conducted on four bank performance ratios using pooled ordinary least square regression, fixed effects, random effects and generalised methods moments. The two-step generalised system methods of moments approach was preferred over the other methods because it eliminated the problem of endogeneity. The results showed that capital adequacy and size have both a positive and negative significant effect on bank performance, while interest rates, non-performing loans, liquidity coverage ratios and net stable funding ratios had a negative and significant effect on bank performance.
The study concluded that South African banks could enhance their performance by tightening their credit risk assessment framework to be more prudent in their lending practices in order to improve the lending quality of their loan books. It is recommended that banks keep their capital levels at a minimum to avoid excessive risk-taking, and that they by embark on efficient revenue enhancement activities such as increasing retained earnings. Banks must further look at their clients on an overall basis, not just a transactional basis, as this will improve their non-interest revenue income by introducing innovative products. Lastly, the banks must lower their liquidity risk exposure by collectively managing their capital adequacy ratio, size of the bank, interest rates, non-performing loans, liquidity coverage ratio and net stable funding ratio. The South African Reserve Bank should tighten regulatory requirements by improving its supervision and oversight functions; banks must to adhere to lending practices and foster a healthy and adequately capitalised balance sheet. Lastly, the SARB must align its macroeconomic forecast for lending rates with regulatory requirements to ensure that economic performance is a catalyst for bank performance. This study contributes to the empirical research repository on the nexus of bank performance and regulatory requirements. More importantly, it identifies the significant factors that affect South African bank performance, by identifying the deficiencies in South Africa’s regulatory requirements, which will provide the South African Reserve Bank with insight into ways of enhancing its regulatory requirements to improve the performance, management practices and sound capital adequacy of the banking sector.Finance, Risk Management and Banking
M.. Com. (Business Management (Finance)
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Paisana, Andreia Filipa Bragança. "Tablet Subdivision: Assessment of compliance with regulatory requirements of medicines marketed in Portugal." Master's thesis, 2019. http://hdl.handle.net/10451/43311.
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Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, Universidade de Lisboa, Faculdade de Farmácia, 2019Resumo Introdução e Objetivos: O objetivo deste estudo foi determinar se os comprimidos com ranhura de divisão, comercializados em Portugal, apresentam uma quebra deficiente e se tal se constitui um obstáculo, nomeadamente para a população idosa. Outro objetivo foi avaliar a conformidade deste tipo de comprimidos com os requisitos regulamentares e identificar possíveis incoerências relacionadas com a rotulagem. Métodos: Foi realizado um estudo com 47 voluntários, de modo a avaliar se a perda de massa durante a subdivisão de comprimidos é significativa e para quantificar a facilidade de quebra de comprimidos para os utentes. Foram incluídos comprimidos “padrão” em cada conjunto dado aos voluntários. Esperava-se que os utentes manifestassem o grau de dificuldade de quebra de modo a ser detetada a quota parte atribuivel a cada utente em si. Antes dos conjuntos serem cedidos aos utentes foram avaliados em laboratório em termos de uniformidade da massa, bem como da resistência ao esmagamento (dureza dos comprimidos) e as dimensões dos mesmos. Esperava-se que estes testes apresentassem resultados relativamente ao desvio de massa e que os mesmos, em conjunto com as características dos comprimidos ajudassem a prever o comportamento dos mesmos no estudo com os voluntários. Resultados: Em cerca de 10% das observações verificou-se a incapacidade dos voluntários em quebrar os comprimidos ou a sua fragmentação em mais do que as duas metades esperadas. Em cerca de metade das avaliações os utentes classificaram os comprimidos como muito fáceis de quebrar. No entanto, num quinto das observações os utentes avaliaram os comprimidos como difíceis ou muito difíceis de quebrar, bem como os casos em que o utente não conseguiu partir o comprimido. Conclusão: A implementação de requisitos regulamentares é de extrema importância, pois critérios mais rigorosos permitirão um menor número de não conformidades e, portanto, maior segurança para o utente em relação ao uso de comprimidos com ranhura de quebra. O uso de modelos de previsão pode ser um recurso útil que permita determinar quais os parâmetros físicos e farmacotécnicos que devem ser otimizados de modo a ser obtida uma subdivisão mais precisa e adequada de comprimidos ranhurados.
Introduction & Aims: The aim of this project was to determine if the tablets bearing a break or score line, marketed in Portugal, present inaccurate subdivision, especially regarding the elderly population. Another aim was to assess the compliance with regulatory requirements of such products, and to target possible issues regarding labelling. Methods: A study comprehending 47 volunteers was performed, to evaluate if mass loss during tablet subdivision is significant and to quantify the ease of subdivision of tablets for the patients. Standard tablets that would be considered either too hard or two easy to break were included in each set given to the volunteers, in order to detect possible patient-related issues. Previously to this study, the mass uniformity of the provided tablets was assessed, as well as the resistance to crushing (tablet hardness) and measurements of the tablets. It was expected that assessments presented mass deviation results and tablet characteristics that would help to predict the behavior of the tablets in the study with the volunteers, as well as an established prediction model. Results: About 10% of the observations reflect either the inability of the volunteers to break the tablets or the splitting of tablets in more fragments than the two expected halves. Around half of the observations correspond to situations in which the patients classified the tablets as very easy to break. However a fifth of the observations represent situations where the patients found the tablets hard or very hard to break as well as cases where the patient was not able to break the tablet. Conclusion: Implementation of regulatory requirements have a particular importance since more strict criteria would allow less non conformities, and therefore more safety for the patient regarding the use of scored tablets. The use of prediction models can be used as an asset in order to determine which tablet physical and pharmacotechnic parameters should be optimized for an enhanced and accurate tablet subdivision.
Laboratório FFULisboa, Farmácia Ferrer Castelo Branco
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Duke, Janet. "Silent values : contextualising justice within the disjunctures between care discourses, regulatory requirements and nursing practice realities /." 2002. http://www.library.unsw.edu.au/~thesis/adt-NUN/public/adt-NUN20031118.112435/index.html.
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Smyth, Clinton Ross. "High altitude coal mine reclamation: an ecological audit of regulatory requirements, planning information and participant attitudes." Thesis, 1995. http://hdl.handle.net/1828/6570.
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Liu, Chiu-Ling, and 劉秋玲. "Utilizing Financial Regulatory Requirements to Improve Management of Bank Internal Audit Function - Case Study of C Bank." Thesis, 2015. http://ndltd.ncl.edu.tw/handle/9b65qm.
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碩士輔仁大學
金融與國際企業學系金融碩士在職專班
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In accordance with international financial supervision’s continuum revisions, Taiwan’s financial supervisory office has been burden with more responsibility and demand for local banking monitoring is higher than ever. However, in order for the competent authority to overlook so many banks with scares manpower and resource, utilizing banks’ internal audit function and financial regulations is the de facto in effective financial supervisory. This study is intend to find that internal auditors as an important factor for implementing an effective internal control. Governmental financial supervising office empower internal auditors with independence, superseding position to evaluate and ameliorate companies improving in risk management, maintain internal control and effective corporate governance. Through internal auditing, it overcome the supervising office’s inability to perform onsite auditing on banks and speeding the implementation of new regulations, also quick understanding of current banking operations and corporate governance. Internal auditors, through auditing and evaluation, discover potential risks and provide correct risk evaluation information before the inevitable lost could realized. Finally with example from C bank, where the internal auditors inspect and evaluate the operating employees , and then report to the appropriate management team, board of auditors, directors and supervisors with suggestions. One should follow thru the suggestions and see they are corrected to establish effective internal control and efficient working environment. Therefore the internal auditing system established from the financial supervising system uplift the importance of auditing management. Internally, it assists the bank, through systematic and discipline way to evaluate and improve risk management, corporate control and management, achieving effective internal control situation and elaborate corporate governance. Externally, it fulfilled the demand and expectation of supervising offices, personnel to contact, maintain communication and deliver banks’ actual internal and external auditing regulation.