Suchergebnisse

It is a central claim of the national competitiveness literature that firms exploit the comparative advantages of their environment by choosing to pursue the product market strategy that is facilitated by national financial- and labour-market institutions. Otherwise, so goes the argument, firms are punished in that strategies receiving no institutional support are less successful and therefore not sustainable in the long run. My analyses of pharmaceutical firms in Germany, Italy and the United Kingdom challenge these arguments on the choice and success of competitive strategies. Given that different measures of strategy success do not indicate that the latter is in line with national institutional advantages, I develop an alternative explanation for the strategy choices of firms. On the basis of my qualitative interviews with managers, I argue that technological opportunities to transform inventions or imitations into marketable products are a primary concern when entrepreneurs choose their firm's strategy.

"One Political Economy, One Competitive Strategy? begins with an assessment of how many pharmaceutical firms in Germany, Italy, and the UK pursue strategies facilitated by national institutions governing the financial markets, antitrust activities, and the labour market. Quantitative analyses reveal that deviant firms, competing through institutionally unsupported strategies, outnumber conforming firms by far. Not only does this finding run counter to the expectations of the competitiveness literature, it brings up a whole new line of inquiry. How can firms compete through strategies that are not supported by national institutions? The book addresses this question and illustrates that firms do not necessarily exploit comparative institutional advantages, but that they can also circumvent institutional constraints. International markets and individual collaboration on a contractual basis allow firms to compete despite comparative institutional disadvantages. These findings suggest that trade liberalization does not lead to strategy specialization but to strategy diversification, depending on the inventiveness of entrepreneurs to develop individual approaches to compete."--BOOK JACKET

How well can people estimate IT‐related risk? Although estimating risk is a fundamental activity in software management and risk is the basis for many decisions, little is known about how well IT‐related risk can be estimated at all. Therefore, we executed a risk estimation experiment with 36 participants. They estimated the probabilities of IT‐related risks and we investigated the effect of the following factors on the quality of the risk estimation: the estimator's age, work experience in computing, (self‐reported) safety awareness and previous experience with this risk, the absolute value of the risk's probability, and the effect of knowing the estimates of the other participants (see: Delphi method). Our main findings are: risk probabilities are difficult to estimate. Younger and inexperienced estimators were not significantly worse than older and more experienced estimators, but the older and more experienced subjects better used the knowledge gained by knowing the other estimators' results. Persons with higher safety awareness tend to overestimate risk probabilities, but can better estimate ordinal ranks of risk probabilities. Previous own experience with a risk leads to an overestimation of its probability (unlike in other fields like medicine or disasters, where experience with a disease leads to more realistic probability estimates and nonexperience to an underestimation).

The world covers more than 190 countries in which at the moment in most of them pharmaceutical legislations and regulatory requirements are established and implemented, e.g. to describe the marketing authorization (MA) procedure for medicinal products. To be able to submit a marketing authorization application (MAA) in all these countries, it is important to know exactly the pharmaceutical legislations (regulations, directives and guidelines) and the regulatory requirements in each of the country in advance. The objective of the pharmaceutical companies is to identify ways and factors that impede the efficient registration of new medicinal products and their timely access to patients. Due to the fact that the European Union (EU) and the United States (US) are the biggest and most potential markets for medicinal products in the world, global working companies focus and analyze the EU and US pharmaceutical legislations and regulatory requirements very detailed in advance and include these requirements from EU and US normally in their development concept of a new medicinal product and consequently in their global regulatory strategy for MAA of this product. But the industry recognized in the last few years also that the other regions of the world – Japan (JP), Latin America (LA), Middle East (ME)/Africa (AFR) and South East Asia (SEA), and are becoming increasingly important to pharmaceutical companies in their global marketing strategies. Therefore companies with global approach realize that it is not sufficient anymore to develop their global regulatory strategy based on the regulatory requirements in EU and US but also to take into consideration the other regions of the world. Based on this knowledge the different pharmaceutical legislations and regulatory requirements for a new MAA of an NBE and NCE on the examples of EU, US, Croatia (as one country of Collaboration Agreement of Drug Regulatory Authorities in European Union Associated Countries (CADREAC)), Brazil, Singapore (as one country of the Association of South-East Asian Nations (ASEAN)) and China are discussed and analyzed in detail. Afterwards the comparison between the different pharmaceutical and regulatory legislations in these countries and the comparison between MAAs for NBEs and NCEs follows. Based on this comparison the general aspects of a global development for a new compound (NBE or NCE) are discussed. The differences in global development between an NBE and an NCE are also covered within this dissertation. Based on this general strategy for global development of new compounds a global regulatory strategy for an NBE on the example of a mAb is developed. As the pharmaceutical legislations and requirements are permanently changing it is of utmost importance that pharmaceutical companies check the current legislations and requirements before starting a global development of a new compound. Also during the development of a new compound the changes in pharmaceutical legislations and regulations have to be checked and have to be incorporated in the global strategy in order to submit a MA dossier according to current requirements. This will ensure that the authorities accept the MA because of following regulations or guidelines. In case a regulation or guideline is not followed the applicant has to be present a justification for doing this approach and it cannot be guaranteed that authorities will accept this. Therefore it is strongly recommended to check the requirements and fulfill all requirements to be able to get an approval for the MA dossier of the newly developed compound. The requirements to get a medicinal product approved and reimbursed increase constantly and it can be anticipated that they will increase further. One possible solution to deal with the increased costs for development and the increasing requirements might be that pharmaceutical companies will merge and will develop new innovative medicinal products together and share the development costs. This will be especially attractive for small and medium-sized companies. Also companies might think about the location of their development centers in order optimize the development. It is recommended that companies will have only one or two global development centers where the global development for all new compounds is done. Pharmaceutical companies should be in closed contact with authorities in order to be able to fulfill all requirements needed to get a new medicinal product approved and marketed. Companies should be also in close contacts with governments especially regarding health care systems in order to fulfill their requirements and in order to be able to influence them with regard to decisions on health care systems. Besides all increasing barriers for getting new products approved and marketed, it is of utmost importance that the development of new innovative medicinal products will be continued to offer patients best medicinal supply. Therefore it seems to be logical that pharmaceutical companies, authorities and governments have to work together and find solutions that the development of new innovative drugs will be attractive and efficient for all sites in future.