Directive 2007/47/EC of the European Parliament amending Medical Device Directive (MDD) provides medical device manufacturers with a compliance framework. However, the effects of the amendments to the MDD on competition in the U.S. medical device software industry are unknown. This study examined the impact of this directive on the competitiveness of U.S. medical device software companies, the safety and efficacy of medical device software, employee training, and recruitment. The conceptual framework for this study included 3 dimensions of medical device regulations: safety, performance, and reliability. The overall research design was a concurrent mixed method study using both quantitative and qualitative techniques. The qualitative techniques involved case studies of 5 purposively selected companies. Data collection involved both surveys and interviews. The sample consisted of 56 employees within medical device firms with markets around the European regions. Qualitative data analysis consisted of descriptive thematic analysis along the study questions and hypotheses and summative evaluation. Quantitative data analysis included descriptive statistics and correlation to test the 4 hypotheses. The results suggested that the MDD has realigned medical device software manufacturing practices, and US medical device companies have gained global competitiveness in improving product safety and increasing sales revenue. Key recommendations to medical device manufacturers include adopting MDD 93/42/EEC, using model-based approaches, and being comprehensive in model use. Adopting the MDD will provide positive social change to patients, as human safety improves with better product quality while companies experience fewer product recalls.

The author sketches the development and legal status of the European Currency Unit (ECU), the predecessor of today's European single currency Euro, and asks whether from the perspective of (former) German monetary law, this currency unit had to be looked at not as a domestic currency ("Deutsche Mark"), but rather as a foreign one.

This diploma thesis quite thoroughly deals with - at present a very topical - theme "liability for damage caused by a defective product"; thus, with an obligation to compensate for the damage caused by the defective product to its user (or third party), generally imposed on the person who is designated as the "producer" of the product, originally based on the Council Directive of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (85/374/EEC) (hereinafter 'Directive 85/374/EEC'). However, this work is not limited only to the (thorough) description of the currently valid and effective Czech implementing legislation. The thesis also compares the Czech legislation with the French implementing regulation, which is of a significantly higher legislative quality and much more faithful to its Union model. In fact, it was specifically France which shaped the final form of this responsibility regime, since it was the French transposition, and the French decision-making (judicial) practice, which was most often the subject of the Court of Justice's, as it ruled on the interpretation of the individual provisions and principles in the text of the previously mentioned directive contained. Nevertheless, France,...

American policy towards European integration process has always seemed equivocal: on one hand it actively supported and encouraged the process, but on the other hand it tried to contain some specific European ambitions and steer the process in a desirable direction. The objective of the thesis is to offer a possible explanation of the long-term US policy towards the European integration and European region in general. The dissertation presents a hypothesis that the American policy towards Europe since the Second World War until current times can be explained within the theorethical concept of "regional hegemony strategy". The concept builds on neorealist and neoliberal interpretations of hegemony, which are applied to the process of formulation of American grand strategy. It identifies a set of independent variables effecting the resulting strategy and operationalizes the expected strategy into particular goals. The empirical part of the dissertation then tests the established hyphothesis in two ways. In the first part it analyzes the identified independent variables and tests the causality betwen their historical evolution and evolution of the American grand strategy, especially in relation to the European region. In the consequent parts, it focuses on the American policy towards the European integration...

La Seconde Guerre mondiale avait complétement interrompu les échanges entre la France et le Pérou. En revanche, au cours des Trente Glorieuses, la France réussit à rétablir une position appréciable au sein de l’économie péruvienne. Grâce à une diplomatie économique active et un engagement diversifié des entreprises privées et publiques, la France devint un partenaire notable de la coopération technique. Ce pays joua un rôle important dans les programmes d’industrialisation et de modernisation du Pérou. Cette thèse s’interroge sur l’évolution et la structure des relations économiques franco-péruviennes entre 1945 et 1975. L’étude se penche sur les échanges commerciaux ainsi que sur les domaines des échanges financiers, de l’industrie et de la coopération technique, combinant des analyses macro et micro-économiques. Il s’agira d’analyser les stratégies et performances des entreprises françaises au sein des grands projets au Pérou en considérant les succès et les limites de leurs engagements. Ainsi, la thèse présente une étude nuancée à propos d’un sujet jamais étudié auparavant et cherche à contribuer d’une manière novatrice aux recherches sur l’histoire des relations entre l’Europe et les pays latino-américains ainsi que sur les rapports Nord-Sud. / The Second World War had completely severed the relations between France and Peru. Throughout the Golden Age of Capitalism, however, France managed to re-establish a considerable position within the Peruvian economy. Thanks to an active economic diplomacy and the various efforts of private and public companies, France became a notable partner in technical cooperation and played, henceforth, an important role in the Peruvian programmes of industrialisation and modernisation. This thesis deals with the evolution and structure of the economic relations between France and Peru from 1945 to 1975. Combining macro- and microeconomic methods, it equally investigates the bilateral trade relations as well as the domains of finance, industry and technical cooperation. The study analyses the strategies and performances of French companies in Peruvian large-scale projects considering their successes as well as their limits. In this way, the thesis presents a nuanced view on a subject, which has never been studied before. It contributes in an innovative way to the research on the relations between Europe and Latin America and between the Global North and South.

Un niveau élevé de protection de la santé humaine est assuré dans la définition et la mise en oeuvre de toutes les politiques et actions de l’Union européenne. L’une des politiques les plus importantes, conformément aux enjeux de santé et au développement économique, est celle des médicaments. Leur sécurité est garantie par un cadre juridique donné par une législation pharmaceutique d’envergure présidant à l’octroi de l’autorisation de mise sur le marché et au suivi post-autorisation. Ce cadre juridique est supporté par un dispositif institutionnel d’exception, caractérisé par une interaction étroite entre l’Agence européenne des médicaments, la Commission européenne et les autorités nationales compétentes. Il a récemment été réformé à travers la nouvelle législation de pharmacovigilance. Le concept de sécurité sanitaire est ainsi devenu le principe directeur de la gestion du risque pharmaceutique. Toutefois, lorsque le risque inhérent à tout produit pharmaceutique se manifeste, le dommage médicamenteux se produit ainsi que la demande de réparation. Face à la nécessité d’indemniser les victimes de tels accidents, les réponses nationales des systèmes juridiques français et italien, par les biais de la responsabilité civile de droit commun et de la responsabilité du fait des produits défectueux issue de la directive 85/374/CEE, se révèlent inefficaces, car peu respectueuses de la spécificité du médicament. Ce constat conduit à plaider en faveur d’une dissociation entre responsabilité et indemnisation, en garantissant cette dernière à travers la création d’un fonds d’indemnisation général pour les dommages médicamenteux à participation mixte public-privé. Cette solution garantit une socialisation des risques justifiée par le caractère social du risque thérapeutique. Cela constitue le contrepoids aux dangers inhérents aux innovations de la science, tout en faisant profiter les malades des bénéfices thérapeutiques de demain. En prônant une approche holistique de la politique du médicament, la proposition de ce fonds constitue un instrument d’une politique de santé publique qui ne voit dans l’indemnisation des risques médicamenteux qu’un complément et un prolongement de la garantie de sécurité à la base de la législation pharmaceutique européenne. / The definition and implementation of the European Union’s policies and activities guarantee a very high level of human health protection. One of its most important policies, in accordance with the relative health and economic development issues, is that on medicinal products. Drug safety is guaranteed by a legal framework, constructed on the pharmaceutical legislation laying down rules and procedures for obtaining marketing authorisation and for post authorisation monitoring. This legal framework is supported by a special institutional system,which in particular ensures close interaction between the European Medicines Agency, the European Commission and the national competent authorities. This legal framework has recently been revised as a result of the new pharmacovigilance legislation. As such, health safety has become a key directive in managing pharmaceutical risk. Yet, whenever a risk relating directly to a particular pharmaceutical product becomes apparent, medical damages and compensation claims arise. The response of the national French and Italian legal systems to the application for compensation of the victims of such accidents, by way of the ordinary rules of civil liability and the liability for defective products as defined in Council Directive85/374/EEC, has proven ineffective: they fail to take into account the specific nature ofpharmaceutical products. Based on this observation, there is a sound case for separating liability from compensation: the latter can be guaranteed by setting up a general compensationfund for medical damages, with both public and private sector participation. This solutionwould guarantee a socialisation of risks that is justified by the social nature of therapeutic risk. It would provide a counterbalance to the dangers inherent in scientific innovation, whilst simultaneously allowing patients to benefit from future therapeutic developments. By advocating a holistic approach to drug policy, this proposed compensation fund would act as apublic health policy instrument, in the context of which compensation for medical risks would only be considered an addition to, and extension of, the security guarantee that constitutes the cornerstone of the European pharmaceutical legislation.

This thesis examines the relationship between the three artists' workshops Røde Mor (Red Mother), Folkets Ateljé (The People's Studio) and GRAS, who worked between 1968 and 1975 in Denmark, Sweden and Norway. Røde Mor was from the outset an articulated Communist graphic workshop loosely organised around collective exhibitions. It developed into a highly productive and professionalised group of artists that made posters by commission for political and social movements. Its artists developed a familiar and popular artistic language characterised by imaginative realism and socialist imagery. Folkets Ateljé, which has never been studied before, was a close knit underground group which created quick and immediate responses to concurrent political issues. This group was founded on the example of Atelier Populaire in France and is strongly related to its practices. Within this comparative study it is the group that comes closest to collective practises around 1968 outside Scandinavia, namely the democratic assembly. The silkscreen workshop GRAS stemmed from the idea of economic and artistic freedom, although socially motivated and politically involved, the group never implemented any doctrine for participation. The aim of this transnational study is to reveal common denominators to the three groups' poster art as it was produced in connection with a Scandinavian experience of 1968. By ‘1968' it is meant the period from the late 1960s till the end of the 1970s. It examines the socio-political conditions under which the groups flourished and shows how these groups operated in conjunction with the political environment of 1968. The thesis explores the relationship between political movements and the collective art making process as it appeared in Scandinavia. To present a comprehensible picture of the impact of 1968 on these groups, their artworks, manifestos, and activities outside of the collective space have been discussed. The argument has presented itself that even though these groups had very similar ideological stances, their posters and techniques differ. This has impacted the artists involved to different degrees, yet made it possible to express the same political goals. It is suggested to be linked with the Scandinavian social democracies and common experience of the radicalisation that took place mostly in the aftermath of 1968 proper. By comparing these three groups' it has been uncovered that even with the same socio-political circumstances and ideological stance divergent styles did develop to embrace these issue.