Implementation of a centralized pharmacovigilance system in academic pan‐European clinical trials : experience from EU‐Response and conect4children consortia

Autor: Terzić, Vida, Levoyer, Léa, Figarella, Mélanie, Bigagli, Elisabetta, Mercier, Noémie, De Gastines, Lucie, Gibowski, Séverine, Trøseid, Marius, Demotes, Jacques, Olsen, Inge Christoffer, Hites, Maya, Ader, Florence, Lopez, José Ramón Arribas, Mentré, France, Espérou, Hélène, Costagliola, Dominique, Røttingen, John‐Arne, Poissy, Julien, Rozé, Jean‐Christophe, Warris, Adilia, O'Leary, Jackie, Fernandes, Ricardo M., Assoumou, Lambert, Hankard, Regis, Turner, Mark, Yazdanpanah, Yazdan, Diallo, Alpha, Holten, Aleksander Rygh, Barratt‐Due, Andreas, Westerheim, Elin, Colban, Martha, Tonby, Kristian, Peiffer‐Smadja, Nathan, Eustace, Joe, Keane, Ruben E., Arribàs, José R., Garcia, Irene, Mazzaferri, Fulvia, Grimaldi, David, Reuter, Jean, Staub, Therese, Berchem, Guy, Delmas, Christelle, Saillard, Juliette, Fougerou‐Leurent, Claire, Ferrane, Assia, Beniguel, Lydie, Baldé, Aliou, Belhadi, Drifa, Dechanet, Aline, Andrejak, Claire, Del Alamo, Marta, Luz, Filipa, Greil, Richard, Keuschnig, Alexandra, Hajdu, Edit, Halanova, Monika, Troníčková, Radka, Trojanek, Milan, Nerušilová, Katerina, Piekarska, Anna, Wiesner, Agnieszka, Bano, Jesus, Tsiodras, Sotirios, Ladenstein, Ruth, Vande Walle, Johan, Degraeuwe, Eva, Kvamme, Anne Mathilde H., Rajasaar, Héli, Kallio, Jaana, Papazisis, Georgios, László, Bálint, O'cleary, Jackie, Ryszard, Sot, Sousa, Catarina, Rodríguez‐Tenreiro, Carmen, Kindblom, Jenny, Ruegger, Christoph, Möller, Alexander, Hawcutt, Daniel, van der Geest, Tessa, Bruggemann, Roger, Neubert, Antje, Drouard, Anne, Dumousseaux, Marina, Moal, Anaelle, Michon, Amelie, Bouazza, Naim, Ursino, Moreno, Hervé, Magali, Boussaha, Inesse, Lozano, Helene, Gueyffier, Francois, Dilo, Ana, Negrini, Anna, Di Maggio, Lucia, Rocchi, Francesca, Polikar, Betty, Cook, Heather, EU‐Response safety group, [missing], c4c safety group, [missing]

Publikováno v: BRITISH JOURNAL OF CLINICAL PHARMACOLOGY
British Journal of Clinical Pharmacology, 89, 4, pp. 1318-1328
British Journal of Clinical Pharmacology, 89, 1318-1328

Contains fulltext : 292812.pdf (Publisher’s version ) (Open Access) Setting-up a high quality, compliant and efficient pharmacovigilance (PV) system in multi-country clinical trials can be more challenging for academic sponsors than for companies.

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::22d1ee0e1fc9cb02bf08a7a3aceac405
https://hdl.handle.net/1854/LU-01GYF80AC5P6B8C9ZKFQJJKKMZ