The European framework surrounding clinical trials on medicinal products for human use is going to change as demonstrated by the large debate at European institutional level. One of the major challenges is to overcome the lack of harmonisation of clinical trial procedures among countries. This aspect is gaining more and more importance, considering the increasing number of multicentre and multinational studies. In this work, the actual European rules governing the Clinical Trial Application have been analysed throughout the different steps including (...) the registration of the trial in the European database; the preparation of documents to be submitted and their contents; the preparation of documents related to the information and consent process; the submission to competent bodies. Specific issues related to paediatric research and trials involving non EU/EEA countries have been addressed as well. Results reveal that the European legislation offers a well defined set of European rules covering different aspects of a Clinical Trial Application. However, these are not suitable to meet the challenges from multicentre and multinational clinical studies. A stronger set of rules, such as is available in a composite European Regulation has been adopted and is expected to harmonise practices and enable sponsors to carry out well conducted trials. But will the new regulation overcome the existing criticisms of Directive 2001/20/EC? (shrink)

In this essay I analyze citational practices around Heinrich von Kleist in Italian postmodern theater and Italian feminist biopolitics. In this realm, the reference to Kleist performs a gesture of interruption of traditional eroticism (Catholic, modern, based on women’s sexual slavery), in particular, by using and rewriting Kleist’s narrative of the Amazons, the legendary tribe of women who would cut their breast to embrace the art of war. Postmodern citations of Kleist introduce a new language around sexuality instead of reenacting (...) the ferocious narrative embedded in the ancient icon. The essay conducts a contrastive reading of two postmodern versions of the Kleistian Amazon in Italy: the first version is Lina Mangiacapre’s and Angela Putino’s philosophical conversation in “Androgina/Amazzone” as well as in Mangiacapre’s stage plays; the second version is Carmelo Bene’s cycle of performances on Achilles’s “necrophilia.” While intellectuals like Laura Mulvey in the UK and Gilles Deleuze in France tend to condemn Kleist for his necrophiliac account of romantic love, in Italy Kleist’s pessimistic image of romantic relationships offers a queer standpoint to develop a sustained critique of violent forms of desire. (shrink)

BackgroundWe describe our experience from a multi-national application of a European Union-funded research-driven paediatric trial (DEEP-2, EudraCT 2012-000353-31; NCT01825512). This paper aims to evaluate the impact of the local and national rules on the trial authorisation process in European and non-European countries. National/local provisions and procedures, number of Ethics Committees and Competent Authorities to be addressed, documentation required, special provisions for the paediatric population, timelines for completing the authorisation process and queries received were collected; compliance with the European provisions were (...) evaluated. Descriptive analysis, Wilcoxon Rank-Sum test and General Linear Model analysis were used to determine factors potentially influencing the timelines. The Cluster Analysis procedure was used to identify homogenous groups of cases.ResultThe authorisation process was completed in 7.7 to 53.8 months in European countries and in 17.1 to 27.1 months in non-European countries. The main factors influencing these timelines were the requests for changes/clarifications in European countries and the different national legislations in non-European countries.ConclusionThis work confirms that the procedures and requirements for the clinical trial application of a paediatric trial are different. In the European Union, the timeframes for submission were generally harmonised but longer. In non-European countries, delays were caused by national dispositions but the entire authorisation process resulted faster with less requests from ECs/cas. The upcoming application of Regulation (EU) 536/2014 is expected to harmonise practices in Europe and possibly outside. Networks on paediatric research acting at international level will be crucial in this effort. (shrink)

Les Prolegomenes a la Philosophie de Platon sont un manuel d'ecole neoplatonicien. Il s'inspire d'un modele dont Proclus a du etre l'auteur, mais l'origine de ce texte est presque surement alexandrine et doit dater de la premiere moitie du Vle siecle. Cette oeuvre est essentielle pour comprendre comment etait diffuse l'enseignement platonicien, et pour mieux saisir le mouvement des idees de l'Antiquite finissante. Dans une importante introduction, L. O. Westerink a retrace l'histoire de l'ecole d'Alexandrie et celle du genre litteraire (...) de ces introductions a Platon et a Aristote. (shrink)

Tuberculosis (TB) is a potentially fatal infectious disease that, in Aotearoa New Zealand (NZ), inequitably affects Asian, Pacific, Middle Eastern, Latin American, and African (MELAA), and Māori people. Medical research involving genome sequencing of TB samples enables more nuanced understanding of disease strains and their transmission. This could inform highly specific health interventions. However, the collection and management of TB isolate samples for research are currently informed by monocultural biomedical models often lacking key ethical considerations. Drawing on a qualitative kaupapa (...) Māori–consistent study, this paper reports on preliminary discussions with groups of Māori, Pacific, and Afghan people in NZ, whose communities have been harmed by TB and TB stigma. Participants’ discussions highlight key concerns and meanings that ought to inform the development of guidelines and a more robust consultative process for the governance of how TB isolate samples are collected and used both retrospectively and in future research. We argue for ethical processes to be culturally nuanced and community-generated, flexible and meaningful, and situated in relation to the physical and symbolic effects of TB. We discuss the significance of Indigenous data sovereignty, rights, and kāwanatanga (governorship) in shaping a multicultural data sovereignty model. (shrink)

are synthetic a priori judgements possible?" In both cases, i~thas usually been t'aken for granted in fife one case by Kant that synthetic a priori judgements were possible, and in the other case in contemporary,'d-". philosophical literature that contingent statements of identity are ppss. ible. I do not intend to deal with the Kantian question except to mention:ssj~".

Purpose. To examine the existential anthropology of G. Marcel and E. Minkowski, in order to demonstrate the necessity of distinguishing the universal-spiritual, as human in human being, apart from the individual-existential in him, and to reveal the hierarchical correlation of biosocial, existential and spiritual spheres in personality. Theoretical basis. Within existential philosophy the author differentiates two separate traditions and proceeds from the insufficiency of the distinction of existential sphere, proposed by phenomenological tradition, showing the necessity of its correlation with the (...) spiritual sphere as a sphere of humanity, proposed by non-phenomenological tradition of G. Marcel and E. Minkowski. Originality. The author presents the anthropological conception of G. Marcel and E. Minkowski, in which human personality is understood as unity of individual-existential and universal-spiritual, which requires a special trans-empirical field of culture, which contains senses, images and symbols of humanity. Also, the author presents the recent developments of existential thinkers in distinguishing existential and spiritual dimensions, both not reducible to the physical and social dimensions. Conclusions. In both existential traditions, the specifically human was founded as a trans-biological and trans-social phenomenon, which appears as indefinable and non-predetermined. But in first tradition, humanity is understood as an existence, as a unique individuality, "project", variant of humanity, equivalent to other variants, and universal is understood as a community of human condition in the world. While in the second tradition, the universal is understood as spiritual. Thus, horizontal level of our private existence, as the process of movement from birth to death, is supplemented by vertical of human, universal ideals and images. Humanity appears as a task, on the way to which human being transcends beyond the limits of his individual "self" to the "super-individual", through inclusion into spiritual community, into universal culture. (shrink)

Trope theory is a leading metaphysical theory in analytic ontology. One of its classic statements is found in the work of Donald C. Williams who argued that tropes qua abstract particulars are the very alphabet of being. The concept of an abstract particular has been repeatedly attacked in the literature. Opponents and proponents of trope theory alike have levelled their criticisms at the abstractness of tropes and the associated act of abstraction. In this paper I defend the concept of a (...) trope qua abstract particular by rejecting arguments that purport to show that tropes should not be understood as abstract and by arguing that the abstractness of tropes plays an indispensable role in one of our more promising trope-theoretic analyses of universals and of concrete objects. (shrink)

Modern scholars have been concerned with the hostility shown to Alexander by the Hellenistic schools of philosophy. Two literary portraits have been distinguished, the Peripatetic and the Stoic, the former deriving from Theophrastus' book on Callisthenes, or starting with this work the Peripatetics worked out a theory of and applied it to Alexander, in order to belittle his achievements. It was a case of giving sophisticated expression to the kind of crude resentment expressed by Demades.

The locus classicus for Plutarch's own views on his methods is in the Alexander He has begun by asking for the indulgence of his readers if they do not find all the exploits of Alexander and Caesar recounted by the biographer or if they discover him not reporting some famous incident in detail (); and he goes on to compare his own search for evidence which will indicate the kind of soul, with the activity of the painter, who, in order (...) to create a likeness, concentrates on the eyes and pays little attention to the other parts. Commentators and critics have been right to take this as a key text for the purpose of understanding Plutarch's attitude towards his biographical work; nevertheless there are other passages in the Lives where we can at least glimpse his attitude to his subject, and we can only see the Alexander-remarks in correct perspective if we take these other passages into account. I propose therefore, starting with the Alexander, to see how far these critical remarks apply to Plutarch's theory and practice elsewhere in the Lives. (shrink)

According to the Ars Amatoria the notorious rape took place on the occasion of a primitive dramatic entertainment staged in a theatre, in which the seats and furnishings were also primitive. There is no time for a description of the arts of the performers—a tibicen and a ludius—before the Romans, impatient for action, receive their signal from Romulus. Nor is there any mention of a god in whose honour the entertainment had been provided.

Catalog of the collection of the Madamkhand Museum of Art, named after the wife of Batzhargalyn Batbai︠a︡r, businessman and member of the Mongolian Khural.

The concept of instantiation is realized differently across a variety of metaphysical theories. A certain realization of the concept in a given theory depends on what roles are specified and associated with the concept and its corresponding term as well as what entities are suited to fill those roles. In this paper, the classic realization of the concept of instantiation in a one-category ontology of abstract particulars or tropes is articulated in a novel way and defended against unaddressed objections.

Se dice que el utilitarismo es incompatible con la defensa de los derechos humanos, pues la búsqueda del mayor bien para el mayor número que prescribe el utilitarismo, puede exigir, en ocasiones, pasar por encima de los derechos. Sin embargo, quizá sea posible ofrecer una solución al conflicto presentando una doctrina utilitarista, reconocible como tal, que sea lo suficientemente amplia como para dar cabida a los derechos. La presente obra tiene como objeto exponer la doctrina de John Stuart Mill como (...) buen ejemplo de cómo es posible llevar a cabo esta tarea. (shrink)

The purpose of this book is to trace the main developments in Greek philosophy during the period which runs from the death of Alexander the Great in 323 B.c. to the end of the Roman Republic. These three centuries, known to us as the Hellenistic Age, witnessed a vast expansion of Greek civilization eastwards, following Alexander's conquests; and later, Greek civilization penetrated deeply into the western Mediterranean world assisted by the political conquerors of Greece, the Romans. But philosophy throughout this (...) time remained a predominantly Greek activity. The most influential thinkers in the Hellenistic world were Stoics, Epicureans and Sceptics. This book gives a concise critical analysis of their ideas and their methods of thought. The last book in English to cover this ground was written sixty years ago. In the interval the subject has moved on, quite rapidly since the last war, but most of the best work is highly specialized. There is a clear need for a general appraisal of Hellenistic philosophy which can provide those who are not specialists with an up-to-date account of the subject. Hellenistic philosophy is often regarded as a dull product of second-rate thinkers who are unable to stand comparison with Plato and Aristotle. This book will help to remove such misconceptions and arouse wider interest in a field which is fascinating both historically and conceptually. (shrink)

In this article, we present, assess and give reasons to reject the popular claim that shame is essentially social. We start by presenting several theses which the social claim has motivated in the philosophical literature. All of them, in their own way, regard shame as displaying a structure in which "others" play an essential role. We argue that while all these theses are true of some important families of shame episodes, none of them generalize so as to motivate the conclusion (...) that shame is an essentially social emotion. We consider each thesis in turn, explaining in the process their connections with one another as well as the constraints on a theory of shame they help uncover. Finally, we show how a non-social picture of shame is not only capable of meeting these constraints, but has the further virtue of shedding light on those situations in which others seem to play no role in why we feel shame. (shrink)

De Interpretatione is among Aristotle's most influential and widely read writings; C. W. A. Whitaker presents the first systematic study of this work, and offers a radical new view of its aims, its structure, and its place in Aristotle's system. He shows that De Interpretatione is not a disjointed essay on ill-connected subjects, as traditionally thought, but a highly organized and systematic treatise on logic, argument, and dialectic.

In den letzten Jahrzehntel! hat sich das Interesse an der Grund­ legung der Mathematik immer gesteigert. Fanden frtiher die wenigen Forscher, die sich emsthaft mit dieser 'Frage beschaftigten, wenig Be­ achtung, heute ist die Teilnahme sowohl von mathematischer wie von philosophischer Seite fast allgemein. Zu diesem Umschwung hat sieher die CANToRSche Mengenlehre, die gleich nach ihrem Entstehen lebhafte Erorterungen tiber ihre Berechtigung hervorrief, den AnstoB gegeben, und besonders die bei riicksichtsloser Durchfiihrung ihrer Grundgedanken auftretenden Widerspriiche zogen die allgemeine Aufmerksamkeit auf (...) sich. Doch ist die bisweUen noch geauBerte Behauptung, der Zweck -der Grundlagenforschung liege in der Beseitigung der Widersprtiche, verfehlt. In philosophischer und in mathematischer Richtung geht diese weit tiber eine solche Zielsetzung hinaus. Philosophisch untersucht man -das Wesen der mathematischen Erkenntnis, ihre Voraussetzungen und Endziele, ihr Verhaltnis zu anderen Wissensgebieten, insbesondere der Physik, und ihre Abgrenzung gegen diese dem lnhalt und der Methode nacho An diese philosophischen Erorterungen schlieBen sich umfangreiche mathematische Untersuchungen tiber den Aufbau der Mathematik aus den philosophisch gegebenen Voraussetzungen und tiber die Struktur der mathematischen Beweisftihrungen. Einzelne Teilgebiete dieser Unter­ suchungen entwickeln sich schon zu selbstandigen Disziplinen, die sich in ihren Methoden und Problemstellungen von der eigentlichen Grund­ lagenforschung unabhangig machen; ein Beispiel eines solchen neuen Zweiges der Mathematik, der sein Entstehen der Grundlagenforschung verdankt, ist die mathematischp. Logik. Allmahlich haben sich drei J. auptrichtungen gebildet, die je einer eigenen Auffassung tiber das Wesen der Mathematik entsprechen undo je zu verschieden gearteten mathematischen Untersuchungen geftihrt haben. (shrink)