Live Biotherapeutic Products, A Road Map for Safety Assessment

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

doi:10.3389/fmed.2020.00237

Public

Live Biotherapeutic Products, A Road Map for Safety Assessment

Published in Frontiers in Medicine • Jun 19, 2020

Authors:

Alice Rouanet

Selin Bolca

Audrey Bru

Abstract

Recent developments in the understanding of the relationship between the microbiota and its host have provided evidence regarding the therapeutic potential of selected microorganisms to prevent or treat disease. According to Directive 2001/83/EC, in the European Union (EU), any product intended to p...

Subject

Commercialization

Directive

Risk analysis (engineering)

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