title: [Not Available].
authors.affiliation: Professeur Emérite Université Paris Est, Créteil, France. Electronic address: f.lemaire@numericable.com.
authors.forename: François
authors.initials: F
authors.lastname: Lemaire
authors.affiliation: Laboratoire Roche, Boulogne Billancourt, France.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Marchenay
authors.affiliation: Université Paris Diderot, Assistance Publique - Hôpitaux de Paris, Paris, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Chassany
authors.affiliation: Laboratoire AstraZeneca, Rueil Malmaison, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Barthélémy
authors.affiliation: Laboratoire Boehringer-Ingelheim, Reims, France.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Bouzzagou
authors.affiliation: AFCROs, Axonal, Nanterre, France.
authors.forename: Denis
authors.initials: D
authors.lastname: Comet
authors.affiliation: ANSM, Saint Denis la Plaine, France.
authors.forename: Cécile
authors.initials: C
authors.lastname: Delval
authors.affiliation: Centre d'Investigation Clinique, Clermont-Ferrand, France.
authors.forename: Claude
authors.initials: C
authors.lastname: Dubray
authors.affiliation: Medtronic, Boulogne Billancourt, France.
authors.forename: Cécile
authors.initials: C
authors.lastname: Fouret
authors.affiliation: CNCPP, Paris, France.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Frija-Orvoen
authors.affiliation: Assistance Publique - Hôpitaux de Paris, Paris, France.
authors.forename: Laetitia
authors.initials: L
authors.lastname: Gambotti
authors.affiliation: Eval Santé, Croissy-sur-Seine, France.
authors.forename: Véronique
authors.initials: V
authors.lastname: Lamarque
authors.affiliation: Voluntis, Suresnes, France.
authors.forename: Geneviève
authors.initials: G
authors.lastname: d'Orsay
authors.affiliation: Hospices Civils, Lyon, France.
authors.forename: Valérie
authors.initials: V
authors.lastname: Plattner
authors.affiliation: LEEM, Les Entreprises du Médicament, Paris, France.
authors.forename: Claire
authors.initials: C
authors.lastname: Sibenaler
authors.affiliation: Laboratoire Glaxosmithkline, Marly-le-Roi, France.
authors.forename: Jacques
authors.initials: J
authors.lastname: Roux
authors.affiliation: Laboratoire Novartis, Rueil Malmaison, France.
authors.forename: Frédérique
authors.initials: F
authors.lastname: Thoby
keywords: ANSM; CPP; dispositifs médicaux; essais cliniques de médicaments; loi Jardé; loi informatique et libertés; règlement européen; transparence; évaluation méthodologique des demandes d’autorisation