Implementation of a Centralized Pharmacovigilance System in Multi-Country European Clinical Trials: Points to Consider for Academic Sponsors and Lessons Learnt from EU-Response and Connect4Children Consortia

Vida Terzić; Léa Levoyer; Mélanie Figarella; Elisabetta Bigagli; Noémie Mercier; Lucie de Gastines; Severine Gibowski; Marius Trøseid; Jacques Demotes; Inge Olsen; Maya Hites; Florence Ader; José Arribas Lopez; France Mentré; Hélèhe Espérou; Dominique Costagliola; John-Arne  Røttingen; Julien Poissy; Jean-Christophe Rozé; Adilia Warris; Jackie O'Leary; Ricardo Fernandes; Lambert Assoumou; Régis Hankard; Mark Turner; Yazdan Yazdanpanah; Alpha Diallo

doi:10.22541/au.166602424.41788458/v1

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Implementation of a Centralized Pharmacovigilance System in Multi-Country European Clinical Trials: Points to Consider for Academic Sponsors and Lessons Learnt from EU-Response and Connect4Children Consortia

Vida Terzić,
Léa Levoyer,
Mélanie Figarella,
Elisabetta Bigagli,
Noémie Mercier,
Lucie de Gastines,
Severine Gibowski,
Marius Trøseid,
Jacques Demotes,
Inge Olsen,
Maya Hites,
Florence Ader,
José Arribas Lopez,
France Mentré,
Hélèhe Espérou,
Dominique Costagliola,
John-Arne Røttingen,
Julien Poissy,
Jean-Christophe Rozé,
Adilia Warris,
Jackie O'Leary,
Ricardo Fernandes,
Lambert Assoumou,
Régis Hankard,
Mark Turner,
Yazdan Yazdanpanah,
Alpha Diallo