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Batch release of vaccines in Europe: from method transfer to first commercial batch available on the market. Straightforward approach that requires a proactive mindset of the manufacturer.

responsibility to choose an OMCL belonging to the OMCL network. This choice, which is free, should be made before filing of the MA application. The initial process involves the transfer of the analytical methods ...

The impact of individual-level heterogeneity on estimated infectious disease burden: a simulation study.

to investigate to what extent ignoring the presence of heterogeneity could bias DALY  computation. METHODS: Simulations using individual-based models for hypothetical infectious diseases with short and ...

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