title: The European "clinical trial" regulation; relationship with the Jardé Act: a Giens workshop.
abstract: 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.
authors: Université Paris Est, Créteil, France.
authors: François
authors: F
authors: Lemaire
authors: Laboratoire Roche, Boulogne Billancourt, France.
authors: Brigitte
authors: B
authors: Marchenay
authors: Université Paris Diderot, Paris, France - Assistance Publique - Hôpitaux de Paris, Paris, France.
authors: Olivier
authors: O
authors: Chassany
authors: Laboratoire AstraZeneca, Rueil Malmaison, France.
authors: Philippe
authors: P
authors: Barthélémy
authors: Laboratoire Boehringer-Ingelheim, Reims, France.
authors: Mohamed
authors: M
authors: Bouzzagou
authors: AFCROs, Axonal, Nanterre, France.
authors: Denis
authors: D
authors: Comet
authors: ANSM, Saint Denis la Plaine, France.
authors: Cécile
authors: C
authors: Delval
authors: Centre d'Investigation Clinique, Clermont-Ferrand, France.
authors: Claude
authors: C
authors: Dubray
authors: Medtronic, Boulogne Billancourt, France.
authors: Cécile
authors: C
authors: Fouret
authors: CNCPP, Paris, France.
authors: Elisabeth
authors: E
authors: Frija-Orvoen
authors: Assistance Publique - Hôpitaux de Paris, Paris, France.
authors: Laetitia
authors: L
authors: Gambotti
authors: Eval Santé, Croissy-sur-Seine, France.
authors: Véronique
authors: V
authors: Lamarque
authors: Voluntis, Suresnes, France.
authors: Geneviève
authors: G
authors: d'Orsay
authors: Hospices Civils, Lyon, France.
authors: Valérie
authors: V
authors: Plattner
authors: LEEM, Les Entreprises du Médicament, Paris, France.
authors: Claire
authors: C
authors: Sibenaler
authors: Laboratoire Glaxosmithkline, Marly-le-Roi, France.
authors: Jacques
authors: J
authors: Roux
authors: Laboratoire Novartis, Rueil Malmaison, France.
authors: Frédérique
authors: F
authors: Thoby
mesh_terms: D022126:Access to Information / Q000331:legislation & jurisprudence; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards; D016494:Computer Security / Q000331:legislation & jurisprudence; D028741:Ethics Committees, Clinical / Q000331:legislation & jurisprudence / Q000458:organization & administration / Q000592:standards; D028744:Ethics Committees, Research / Q000331:legislation & jurisprudence / Q000458:organization & administration / Q000592:standards; D005062:European Union; D005602:France; D006077:Government Agencies; D006805:Human Experimentation / Q000331:legislation & jurisprudence; D006801:Humans; D007802:Language; D062307:Medical Device Legislation; D064887:Observational Studies as Topic / Q000331:legislation & jurisprudence; D012107:Research Design / Q000592:standards