The European "clinical trial" regulation; relationship with the Jardé Act: a Giens workshop.

Autor:	Lemaire F; Université Paris Est, Créteil, France., Marchenay B; Laboratoire Roche, Boulogne Billancourt, France., Chassany O; Université Paris Diderot, Paris, France - Assistance Publique - Hôpitaux de Paris, Paris, France., Barthélémy P; Laboratoire AstraZeneca, Rueil Malmaison, France., Bouzzagou M; Laboratoire Boehringer-Ingelheim, Reims, France., Comet D; AFCROs, Axonal, Nanterre, France., Delval C; ANSM, Saint Denis la Plaine, France., Dubray C; Centre d'Investigation Clinique, Clermont-Ferrand, France., Fouret C; Medtronic, Boulogne Billancourt, France., Frija-Orvoen E; CNCPP, Paris, France., Gambotti L; Assistance Publique - Hôpitaux de Paris, Paris, France., Lamarque V; Eval Santé, Croissy-sur-Seine, France., d'Orsay G; Voluntis, Suresnes, France., Plattner V; Hospices Civils, Lyon, France., Sibenaler C; LEEM, Les Entreprises du Médicament, Paris, France., Roux J; Laboratoire Glaxosmithkline, Marly-le-Roi, France., Thoby F; Laboratoire Novartis, Rueil Malmaison, France.
Jazyk:	English; French
Zdroj:	Therapie [Therapie] 2015 Jan-Feb; Vol. 70 (1), pp. 21-36. Date of Electronic Publication: 2015 Feb 16.
DOI:	10.2515/therapie/2014234
Abstrakt:	In May 2014, the European Union Parliament and Council published a new regulation on clinical trials on medicinal products for human use, which is designed to replace Directive 2001/20/EC. It will not come into effect until 2016. Nevertheless, it is essential to examine its relationship with national legislation, i.e. the Jardé Act, whose implementation has been delayed pending publication of the European regulation. The Giens workshop identified and examined the various issues that this relationship is bound to raise. In particular, it looked at trial methodology assessment procedures, the working relationship between the French National Agency of Drug Safety and Health Products (Agence Nationale de Sécurité du Médicament et des Produits de Santé, ANSM) and ethics committees during the authorization application evaluation phase, review of post-authorization/registration studies on medicinal products and medical devices, and data transparency. (© 2015 Société Française de Pharmacologie et de Thérapeutique.)
Databáze:	MEDLINE
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