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)

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)

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)