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Clinical Research is expanding into an international and more regulated environment, specifically its quality management. Pharmaceuticals and Research Organizations are investing significant amounts of money as well as the regulatory agencies. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are improving and developing regulations and meetings to standardize globally these practices. Therefore this Thesis integrates and extends the FDA and EMA recommendation of implementing “Risk based quality management” in Clinical Research protocol execution with a multisource point of view and the proposal of adding a Risk Management Report as an output, which will work also as an input for future protocols implementation. Diverse articles and regulations related with Quality Management and Clinical Research Processes were reviewed to work as a base for the analysis of this thesis. Risk Based Quality Management is the actual trend and newly implemented process to improve quality in clinical research. The goal of this Thesis is to combine the different actual factors, methods and regulations in order to expand Risk Based Quality Management and reach a better degree in quality and standardization. The question therefore is whether this redesigned Risk Based Quality Management process can really be incorporated with the actual practices, and if it is possible to adopt it in Clinical Research.
Globally operating stamping and hybrid parts manufacturer KRAMSKI and the FRANUHOFER IPA have developed a new prosthetic foot designed for developing countries. Although low-cost solutions in developing countries exist, these significantly lack functionality. The new prosthetic foot will be more expensive than most low-cost alternatives, which start from $ 5.00 for a simple SACH foot, but can be sold for a much lower price than most high-tech prosthetics imported from industrialized nations, which can cost more than $5,000. The purpose of the paper was to determine the market potential for the prosthetic foot, to monitor the competition and to create an overall marketing concept for distributing and promoting the product. Therefore market and competitor analyses were conducted. On base of the market and competitor research, strategies were formulated. As a last step, the marketing mix with its four elements was regarded and different distribution and promotional tools have been reviewed to propose marketing activities that could be undertaken by KRAMSKI. Since six different target countries in Asia and Latin America (India, Sri Lanka, Cambodia, El Salvador, Guatemala, and Honduras) were chosen in agreement with KRAMSKI, the market potential for each of these countries was estimated. Two different approaches were used to estimate the market potential of each country. Following the first approach, the total market demand of all six countries added up to more than 5.6 million potential. The second approach added up to a total of 6.7 million potential customers for the target regions. The numbers revealed that 95 % of all lower limb amputees lived in India. Therefore India has been chosen as the target country for all further research in the paper. The monitoring of the market change revealed that prosthetic foot demand was going to increase over the next decades due to lost limbs through road traffic incidents and diabetes. Besides, by the year 2030 most of the world’s middle class (80 %) will be living in developing countries As a consequence, more people will be able to afford health care products such as prosthetic feet. It has been found out that customers in developing countries lay emphasis on either low cost or quality. As a second step, the competitive environment within the prosthetic foot sector in India has been analyzed. Although the Indian healthcare system is still underdeveloped, the sector offers future opportunities for the private sector. The biggest commercial manufacturers of prosthetic feet in India are Otto Bock, Endolite and Streifeneder-Collegepark. But also international and local NGOs, such as BMVSS (Bhagwan Mahaveer Viklang Sahayata Samiti) with the Jaipur Foot, distribute prosthetic feet. Most of the commercial products are significantly more expensive than the products distributed by NGOs. Most NGOs manufacture prosthesis by themselves in order to save costs and create jobs. Many amputees can receive the prostheses and service for free due to donations which finance the NGOs. The competitive suppliers either own fitting centers or distribute their products through local wholesalers. On base of the market, consumer segmentation has been conducted. The Indian population has been divided into different income levels. Rural aspirers and urban seekers could be seen as the most profitable target segments, but urban customers might be easiest to reach due to location. In a last step, the marketing mix for the prosthetic foot has been analyzed. The prosthetic foot should offer specific features to align with developing countries. The product needs to be priced according to company objectives, demand, cost and competition. Since KRAMSKI does not yet have the capabilities and resources to fit prosthetic feet, the company needs to distribute to the end-user through indirect distribution channels such as wholesalers, clinics and NGOs. Therefore an important activity for KRAMSKI is the acquisition of distribution channels. This can be approached through promotional tools such as personal selling, direct marketing, online marketing or the participation on trade fairs and exhibitions.
The purpose of this thesis is to investigate the fairly recent Basel III regulations, and to find out if they have impacts on the financing of small and medium-sized enterprises. Therefore, the theoretical impacts on financial institutions and on small and medium-sized enterprises would be analysed and compared to the real development. Basel III is an advancement to Basel I and II and contains stricter capital and liquidity requirement regulations for financial institutions, as well as a leverage ratio. The purpose is to create a financial sector, which would be more resistant against crises. Because the liquidity requirements and the leverage ratio are not, or only partly introduced yet, the thesis focuses more on the capital requirements. These requirements, demand banks to deposit a higher percentage of equity for each credit operation, depending on the risk. It is expected that financial institutions will face an excess need of capital to fulfil the requirements. On the one hand, banks could increase their equity, which hypothetically could lead to higher capital costs as well as an increase of credit costs. That would in turn result in worse credit terms for SMEs. On the other hand, banks could reduce their risk-weighted assets to lower the need for new capital. That could minimize the capacity of the credit business and lead to difficulties for SMEs in obtaining a loan. An empirical study, based on a theoretical simulation, came to the result that there will be a slight worsening of the credit terms and the credit supply for SMEs. Regarding to the question “if the new capital requirements are appropriate for SME-loans”, it shows that there is no increase of risk in that segment. Therefore, the capital requirements should be adjusted for these kind of loans. The theoretical impacts of the liquidity requirements and the leverage ratio are also expected to affect the loans for SMEs, which are the second important financing instrument. To compare and analyse the theoretical impacts to the real development, latest empirical studies were used to get a picture of the current situation. It shows that the group of financial institutions that are relevant for SME-loans have a moderate increase in their equity basis and almost no decrease of their risk-weighted assets. Theoretically, that should lead to worse credit terms and no change in the credit supply. While analysing the realised external funds made in recent years, it is affirmed that there is no decline in the credit supply. Regarding the increased capital basis, there is no worsening in the credit terms perceived in the reality. The favourable key interest rate could be the reason for that, because it compensates the increased capital cost. Hence, Basel III does not represents a threat to the mid-sized sector in average. However, it can be stated that, the smaller the enterprises are, the more difficult it is to get a loan and the worse the conditions are.
Diese Arbeit behandelt die Thematik der Kundenzufriedenheit, welche in Forschung und Praxis auf Grund ihres hohen Einflusses auf den Unternehmenserfolg nach wie vor an Bedeutung gewinnt. Anhand des Beispiels der SCOPE Messestrategie GmbH, Veranstalter der HORIZON Messe für Studium und Abiturientenausbildung, wird die
Vorgehensweise bei der Durchführung einer Kundenzufriedenheitsanalyse im Messewesen dargelegt. Die Ergebnisse dieser Analyse zeigen, welchen Dienstleistungseigenschaften einer Bildungsmesse besondere Bedeutung beizumessen ist und wie man auf Basis dieser Erkenntnisse eine Steigerung der Ausstellerzufriedenheit bewirken kann.
Background
The recent worldwide financial crisis that occurred in last quarters of 2007 up until mid 2009 was accompanied by the massive failure of many financial institutions and liquidity providers. Investment banks and other institutionalized financial investors were unsuccessful in producing any real returns for their clients. This drastic fail in all the other traditional investments led to the questioning of how well the hedge fund industry performed in this light based on their promise as absolute return producers regardless of the market environment. This paper seeks to analyse the performance of the Long/Short Equity Strategy in particular relative to the performance of the overall market.
Methods
Thorough examination and validation of numerous empirical studies which have already been carried out on the subject matter are brought to light through the analysis of available historical data of the returns posted by these funds during the crisis using generally accepted statistical funds’ assessment tools giving an adequate angel to the performance of Long-Short Equity hedge Funds especially at the heart of the financial crisis in the last quarters of 2007 to mid 2009.
Results
Equity Long/Short Hedge funds as every other strategy in they industry succeeded in 2008 in outperforming other traditional investment vehicles and the broad stock an bond markets although the failed in to produce the absolute returns promised to their investments. In 2009 they posted similar results to that of S&P 500 index with subsequent declines in 2010 and 2011 thus failing to period their returns where highly correlated with that of the overall market coined with negative skewness and high kutorsis.
Conclusion
Even though hedge funds succeeded in outperforming the market in the heart of the crisis, they failed to provides their investors with absolute returns and also the benefits which the provide in terms of diversification to reduce the exposure of their funds to market risk was limiting. The very high fees paid to them by investors was not justified by their performance.