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Le règlement européen « essais cliniques » : articulation avec la loi Jardé : un atelier de Giens.
Lemaire F, Marchenay B, Chassany O, Barthélémy P; les participants à la table ronde N°2 de Giens XXX :; Bouzzagou M, Comet D, Delval C, Dubray C, Fouret C, Frija-Orvoen E, Gambotti L, Lamarque V, d'Orsay G, Plattner V, Sibenaler C, Roux J, Thoby F. Lemaire F, et al. Therapie. 2015 Jan-Feb;70(1):21-8. doi: 10.2515/therapie/2014229. Therapie. 2015. PMID: 27393394 French. No abstract available.
The European "clinical trial" regulation; relationship with the Jardé Act: a Giens workshop.
Lemaire F, Marchenay B, Chassany O; participants of round table N°2 of Giens XXX:; Barthélémy P, Bouzzagou M, Comet D, Delval C, Dubray C, Fouret C, Frija-Orvoen E, Gambotti L, Lamarque V, d'Orsay G, Plattner V, Sibenaler C, Roux J, Thoby F. Lemaire F, et al. Therapie. 2015 Jan-Feb;70(1):21-36. doi: 10.2515/therapie/2014234. Epub 2015 Feb 16. Therapie. 2015. PMID: 25679191 English, French.
Comment garantir des données médicales de qualité dans les études cliniques, pharmaco-épidémiologiques et en pharmacovigilance ?
Alla F, Rosilio M, Funck-Brentano C; les participants à la table ronde N° 2 de Giens XXVIII :; Barthélémy P, Brisset S, Cellier D, Chassany O, Demarez JP, Diebolt V, Francillon A, Gambotti L, Hannachi H, Lechat P, Lemaire F, Lièvre M, Misse C, Nguon M, Pariente A, Rosenheim M, Weisslinger-Darmon N. Alla F, et al. Among authors: lemaire f. Therapie. 2013 Jul-Aug;68(4):209-16. doi: 10.2515/therapie/2013035. Therapie. 2013. PMID: 27392724 French. No abstract available.
How can the quality of medical data in pharmacovigilance, pharmacoepidemiology and clinical studies be guaranteed?
Alla F, Rosilio M, Funck-Brentano C; Participants of round table N° 2 of Giens Workshops XXVIII (th); Barthélémy P, Brisset S, Cellier D, Chassany O, Demarez JP, Diebolt V, Francillon A, Gambotti L, Hannachi H, Lechat P, Lemaire F, Lièvre M, Misse C, Nguon M, Pariente A, Rosenheim M, Weisslinger-Darmon N. Alla F, et al. Among authors: lemaire f. Therapie. 2013 Jul-Aug;68(4):209-23. doi: 10.2515/therapie/2013040. Epub 2013 Aug 28. Therapie. 2013. PMID: 23981258 Free article. English, French.
332 results