Live biotherapeutic products: the importance of a defined regulatory framework

por Cordaillat-Simmons, Magali, Rouanet, Alice, Pot, Bruno
Publicado 2020

Entering First-in-Human Clinical Study With a Single-Strain Live Biotherapeutic Product: Input and Feedback Gained From the EMA and the FDA

por Paquet, Jeanne-Céleste, Claus, Sandrine P., Cordaillat-Simmons, Magali, Mazier, Wilfrid, Rawadi, Georges, Rinaldi, Laure, Elustondo, Frédéric, Rouanet, Alice
Publicado 2021

Live Biotherapeutic Products, A Road Map for Safety Assessment

por Rouanet, Alice, Bolca, Selin, Bru, Audrey, Claes, Ingmar, Cvejic, Helene, Girgis, Haymen, Harper, Ashton, Lavergne, Sidonie N., Mathys, Sophie, Pane, Marco, Pot, Bruno, Shortt, Colette, Alkema, Wynand, Bezulowsky, Constance, Blanquet-Diot, Stephanie, Chassard, Christophe, Claus, Sandrine P., Hadida, Benjamin, Hemmingsen, Charlotte, Jeune, Cyrille, Lindman, Björn, Midzi, Garikai, Mogna, Luca, Movitz, Charlotta, Nasir, Nail, Oberreither, Manfred, Seegers, Jos F. M. L., Sterkman, Luc, Valo, Audrey, Vieville, Frédérique, Cordaillat-Simmons, Magali
Publicado 2020