Résultats de la recherche - 3 results
Training on the assessment of quality part (M3) of the eCTD for the registration of vaccines for human use
registration of vaccines for human use, Sciensano, Brussels, Belgium (2023) Keywords: assessment module 3 vaccines Health Topics: Vaccine batch conformity Vaccin lot conformiteit Conformité de lot de vaccin ...
The consistency approach for the substitution of in vivo testing for the quality control of established vaccines: practical considerations and progressive vision
Publication Type: Peer reviewed scientific article Authors: L. Tesolin; J.-F. Dierick; Wim Van Molle Source: Open Research Europe (2022) Keywords: human vaccines in vitro testing in vivo testing ...
Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mind-set of the manufacturer.
medicinal products or medicinal products derived from human blood or plasma by an Official Medicines Control Laboratory (OMCL) before these can be marketed. The competent authorities issue a Batch Release ...