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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.
In the last 30 years academics were exploring the field of ethical consumption and identified an attitude - behavior gap in the decision making process. Since then diverse studies have been implemented to understand ethical consumers' attitudes, motives and behavior. Parallel to the academic research being developed, there had been an increasing interest from the consumer side in behaving and consuming more ethically. Particularly, consumers have inclined their ethical purchases towards fair trade products. The present exploratory research implemented a quantitative metaphoric method called Zaltman Elicitation Metaphoric Technique (ZMET) to further contribute in the literature of ethical and fair trade consumption. The ZMET in-depth interviews were carried out with 10 German fair trade food consumers during the months of February and March in 2015. The results revealed a connection between participants' feelings, emotions, personal values and fair trade food consumption; likewise the research identified an association of fair trade to sustainability.
Unfortunately, even in these years of high innovations in society, many countries still have gaps in basic needs such as energy supply. Many people live off-the-grid (OTG) referring to not being connected to the main or national electrical grid since they live scattered or in remote location or simple because it is unaffordable. On the other hand, according to the International Energy Agency (IEA), the use of fossil energy increased in the 8 firsts years of the 2000 decade, and half of the energy use in the last decade was accounted to coal. This type of energy source is proven to be harmful for the environment contributing to global warming. New methods of energy storage have been created mainly in developed countries. For example, the photovoltaic (PV) lamps as the main product of a German company that fulfill needs in sustainable and renewable energy resources. However, developing countries may also need to look for practical solutions and the private sector can help. The financing of renewable alternatives is imperative to increase progress and, in these sense, private sector can help. For instance, increasing systems using solar energy for rural communities and promotion of affordable and efficient PV products such as portable eco-friendly solar lamps that replace the kerosene lamps, fan plus lamps, water filters and icemakers among others are helpful in OTG communities and need to be supply. Entrepreneurs that focus in fulfill this gap in society creates value and make a change in the countries. The importance of increase electronic appliances (energy-efficient) and “smart” applications (home area networks and energy storage devices) is undeniable for progress in developing countries and better energy use all over the world Solar energy provides products that not only help people but also maintains a balance between nature and habitants.
Market entry strategy for German mittelstand medical device
companies into the Indian market.
(2015)
German medical devices companies are at the forefront of technology when it comes to innovation and R&D. Most of the European medical device manufacturing companies are located in Germany and the number of patents filed by these companies shows the amount of innovation in the industry. A majority of these medical devices are exported within the European Union countries. Economic slowdown combined with market saturation and increased competition makes Europe a very competitive market for these companies. Indian on the other hand is one of the fasted growing economies in the world. The Indian medical device sector is relatively an untapped markets for innovative medical devices. There are tremendous market opportunities due to the fact that local manufacturing base for medical devices are underdeveloped
and often neglected. Most of the local Indian manufactures are engaged in producing basic medical devices and mostly into medical disposables and supplies. Around 70% of the medical devise sold in India are imported products. There is a huge demand and supply gap that is not being filled by the local manufacturers. India offers the perfect new market opportunity for German medical companies looking to venture into emerging new markets. There is abundant supplied of skilled manpower, with wages lower than that of the neighbouring China. India also has a rapidly growing middle class with increasing purchasing power. However, the regulations in the Indian medical device industry are not very clear and transparent. The Indian bureaucratic system is rampant with corruption and red tapes that needs to be tackled and navigated skilfully. A Germany company looking to enter the Indian market needs to understand that nothing in India can be implemented by a text book style entry strategy. In this thesis, we will analyse few of the most suitable entry strategies for German medical device companies with the advantages and disadvantages of each entry mode. We will also analyse the process of doing business in India, which requires an understanding of various aspect of the Indian culture and business relationship building in India. Further, we will analyse the current market scenario with a brief analyse of the local manufacturers currently in the market along with some information on foreign players in the market. Will also interview 5 experts from the medical field and look into few real case studies.
Purpose: This study investigates the role that entrepreneurial talents play, and the influence of such
talents in firms’ success and raising funds through crowd-funding platforms as well. It discusses and analyses which talents are needed by entrepreneurs in order to place them in the best position to attract funds from these platforms. Further, the study attempts to create a bridge between entrepreneurial talent and crowdfunding, hence acting as one of the contributors towards the entrepreneur’s business success. Design/Approach/Methodology: This topic is a novel idea and it aims at examining whether or not entrepreneurial talents, as influencing factors should be taken into account when raising funds from crowdfunding platforms. This paper includes two main parts: theoretical and practical. In the final part, this paper provides lessons learnt. Originality/Value: This thesis will add value to research in the field of crowdfunding and its operation especially when entrepreneur funding is considered. Additionally, the hypothesis that forms the basis of this thesis, advocates for a new mode of sourcing for funds from crowdfunding platforms. This new approach is premised on the idea that the entrepreneurial talent can be a significant influencing factor for successfully raising funds from crowdfunding platforms. The analysis of the case studies will reveal an appropriate pattern of the talents needed and associating factors that will help entrepreneurs become successful in obtaining funds for their business
ventures, when they elect to use crowdfunding as their financing method. Practical implications: There are four practical implications to this paper. The first, is that entrepreneurs who intend to seize the huge opportunities offered by the crowdfunding platforms should place emphasis on convincing the participants in the platforms of their talents rather than placing too much focus on perfect business plan. Secondly, the platform participants should deviate from the traditional approach of WHAT to invest in, to a new approach of WHOM/WHO to invest in. Thirdly, from the perspective of the relatively new crowdfunding industry, this paper proposes for the creation of talent-based crowdfunding platforms as opposed to the project-based ones that are currently operating. Finally, the paper encourages the academic researcher to pursue ideas and new applications in the crowdfunding industry.
The study seeks for empirical evidence supporting the presence of weak form ans semi-strong form efficiency on the Vietnamese stock market. The sample includes the daily closing value of VN-index from 9th April 2009 to 3rd of December 2014. The results from both parametric and non-parametric tests provide the evidence, which implies the weak form efficiency in the Vietnamese stock market during the recent period from 4th June 2012 to 3rd December 2014. This period is used for testing the semi-strong form efficiency on the Vietnamese stock market. The results from event study do not support the semi-strong form efficiency in the Vietnamese stock market. The empirical evidence shows a delayed reaction of nine pharmaceutical companies' stock prices toward the earnings, dividend, insider trading and regulatory announcements. The findings in this paper are crucial for investors, analysts, academicians, regulators and the development of the Vietnamese stock market.