No abstract

Résumé À partir d’une pratique analytique avec les enfants, inscrite au cœur de différents pays (France, États-Unis d’Amérique, Togo, Bolivie, Vietnam), nous explorons les dimensions et les enjeux de l’inscription subjective, au-delà de la culture et de la société d’appartenance. C’est à travers les enseignements de Sigmund Freud et de Jacques Lacan que nous examinons, tout d’abord, la question du désir d’enfant. Puis nous étudions les moments logiques, où se joue ce passage de l’ infans à l’enfant et la structure du sujet, qui en découle. Enfin, nous soulignons comment, pour chaque enfant, quelle que soit sa culture ou son origine, l’entrée dans le monde symbolique est déterminante, car elle lui permet de s’emparer du langage, afin de confirmer son inscription dans une lignée et d’adopter son sexe propre.

The European Directive on clinical trials of medicinal products will fall within the scope of the legislation of Member States on 1 May 2004. In France, this adaptation will be carried out by a public health bill concerning, among other things, the reform of the current Huriet-Sérusclat law, and by means of regulations. For trials concerning the initial administration of a product to human subjects, the group suggested the following recommendations:• In French texts, to include a deadline of 30 days for the initial authorisation by the competent authority (Afssaps [Agence française de sécurité sanitaire des produits de santé]).• To maintain an observed deadline of 20 days (35 official days) for the decision of the Ethics Committee (EC) [Committee for the Protection of Persons (CPP)].• To obtain a more specific evaluation of the pharmaceutical dossier of the investigational medicinal product (IMP) from the competent authority.• To provide both bodies with nonclinical and possibly clinical data concerning the IMP information of the participants and their consent.• To follow the recommendations posted on the Afssaps website for the entire IMP dossier.• To submit a protocol under the International Committee on Harmonisation (ICH) E6 format adapted for phase I and, possibly as a separate document, justification of a certain number of points (a total of ten) that are more specific to this trial phase to facilitate and improve the document review while also providing the expected guarantees.• To limit the 'substantial' amendments to those provided for in the European guidelines.• To break the blind for every serious event reported to the sponsor by the investigator, and report to the competent authority any serious adverse event related to the IMP or to the trial or without documented cause, while keeping ECs and investigators informed. Furthermore, certain points concerning the authorisations for packaging, labelling and dispensing of the batches of medicinal products for clinical trials will need to be specified for these early studies.All these recommendations are intended to help promote the development of studies involving the initial administration of medicinal products in France.