Este artículo se concentra en dos de los programas que forman parte del Séptimo Programa Marco de Investigación y Desarrollo Tecnológico: «Ideas» y «Personas». En él discutimos la filosofía de los programas, su importancia para la innovación y la investigación y las barreras que dificultan su implementación y desarrollo. ; This article focuses on two programmes in the Seventh Framework Programme for Research and Technological Development: "Ideas" and "People". It discusses the philosophy of the programmes, their importance for innovation and research, and the obstacles hindering their implementation and development. ; Este artículo se concentra en dos de los programas que forman parte del Séptimo Programa Marco de Investigación y Desarrollo Tecnológico: «Ideas» y «Personas». En él discutimos la filosofía de los programas, su importancia para la innovación y la investigación y las barreras que dificultan su implementación y desarrollo.
Three quarters of all medications marketed today do not carry Food and Drug Administration (FDA) approved labeling for use in neonates, infants, children and adolescents. This has been stated by the pediatric pharmacology research unit Network which is established by the national institute of Child Health and Human Development in the United States. It is shocking to note that few drugs, only approximately 20% of all drugs marketed in the United States, have been labeled for use by infants and children. Eighty percent or more of drugs approved since 1962 have been approved and labeled for use in adults with a disclaimer in the labeling that they are not approved for use by children (as indicated by the American Academy of Pediatrics in September 12,1996). Many commercially available drugs are only licensed for use in adults and are not used according to the product licensing in pediatric practice. Only minorities of the currently marketed drugs have undergone pediatric clinical trials and have approved labeling for use in children. These include common antimicrobial agents, medications for fever, vaccines and some asthma and allergy medications. However, most drugs used to treat illnesses in children have never been formally tested or approved for pediatric use and lack even basic dosage recommendations for children in their labeling. These include such routinely used medications as dopamine (used to treat shock), cisapride (used to treat abnormal regurgitation of stomach contents in infants and small children), ketorolac (the only available injectable non-narcotic pain reliever), midazolam (used as a sedative and to treat convulsions) and adenosine (used to treat life threatening abnormal heart beats) and the list is much longer. The treatment of pediatric patients with drugs in hospitals is being impeded by a shortage in the availability of licensed drugs in an appropriate formulation. There are several reasons for this situation, ethical problem of research in children, the reluctance of parents to allow their children to participate in drug trials and the technical challenges small study participants bring along. Possibly because of the underestimation of the problem, there is a lack of funding from governments, health care providers and industry. As a result, pediatric drug trials are relatively scarce and in many cases contain only a limited number of patients. The purpose of licensing is to ensure that medicines are examined for safety, efficacy and quality. Most medicines administered to adults have a product license that outlines the particular indication, dose and route of administration for a drug. However, many medicines used for children are not licensed for use in children or are used outside the terms of product license ('off label'). This means that the risks or benefits of using a drug in that particular situation have not been examined by the licensing authority. The aim of this review is to emphasize the need to make studies and to focus on dosing and safety data for children in an appropriate pediatric population a requirement during clinical trials of each new drug with potential use by children. This review also discusses the operation of the licensing system and the use of unlicensed and off-label drugs in children.
The contributions to this book have discussed various legal aspects of the phenomenon of integrated administration in the EU and have contributed to developing a better understanding of the legal framework thereof. This has not been a simple task, not least because the founding treaties had not provided for a legal framework for this administrative integration. It was due to the evolutionary and diversified development of forms of integrated administration, that many new and unforeseen legal problems have arisen. They are often the result of forms of non-hierarchic, network-like structures and procedures of administrative cooperation in the EU. Across policy areas a general tendency can be observed of integrating a multitude of administrative actors from different jurisdictions in joint procedures. This often results in a mix of legal systems' rules being applicable to a single administrative procedure.
Le Conseil européen de Tampere a formulé l'objectif ambitieux d'élaborer " un régime d'asile européen commun, fondé sur l'application intégrale et globale de la Convention de Genève et assurer ainsi que nul ne sera renvoyé là où il risque à nouveau d'être persécuté ". Cela s'est traduit par l'adoption des directives communautaires appelées communément " protection temporaire ", " conditions d'accueil ", " qualification " et " procédure " dont la transposition en droit luxembourgeois a été réalisée par la loi du 5 mai 2006 relative au droit d'asile et à des formes complémentaires de protection. Afin d'analyser ces développements récents du droit d'asile dans la double perspective luxembourgeoise et européenne, le présent ouvrage rassemble les contributions présentées lors d'une journée d'étude, organisée en coopération avec l'agence des Nations Unies pour les réfugiés (UNNCR), qui s'est tenue à l'Université du Luxembourg le 2 avril 2009. Dans la perspective luxembourgeoise, l'ouvrage aborde les aspects pratiques tels que l'accès au travail ainsi que la question fondamentale du rôle du juge, qui a fait l'objet d'une précieuse étude de jurisprudence élaborée sous l'égide de l'UNHCR. Dans la perspective comparative, européenne et internationale sont ensuite traités les efforts d'harmonisation les plus récents ainsi que la notion de groupe social au sens de la Convention de Genève de 1951.
Over the years, and in order to bypass the limits associated to the characteristics of the EU (budget limitations for instance), the Commission has put forward new modes of governance. In part, the EU's legitimacy discourse relies upon systematic innovation around new modes of governance promoted by the newly enlarged EU for the new millennium (.).
Since globalization is not only restricted to economic and political relationships, but literally 'hits home', it has become indispensable to look beyond national boundaries and to take international developments into account in the field of family law. Hence, comparative family law is blooming. The core part of this contribution to the special issue on 'Current Debates in Family Law around the Globe' is aimed at framing the context of comparative family law. The main questions are: How is comparative family law perceived by the academic community and practitioners alike? What should it entail? In the attempt to find answers to these questions, several comparative family law projects, which have been carried out both in Europe and in the United States, have been compared. Whereas family law experts in Europe decidedly contribute to the comparative law methodology debate, similar discussions seemingly do not take place in the United States. It has been examined why this may be the case.
Over the years, and in order to bypass the limits associated to the characteristics of the EU (budget limitations for instance), the Commission has put forward new modes of governance. In part, the EU's legitimacy discourse relies upon systematic innovation around new modes of governance promoted by the newly enlarged EU for the new millennium (.).
Over the years, and in order to bypass the limits associated to the characteristics of the EU (budget limitations for instance), the Commission has put forward new modes of governance. In part, the EU's legitimacy discourse relies upon systematic innovation around new modes of governance promoted by the newly enlarged EU for the new millennium (.).
