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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 ...
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.
to mention some of them. Assay variability and possible changes in analytical methods and specifications during the registration procedure should also be closely monitored. The full method transfer and ...