Zoekresultaten - 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 ...
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 ...
Implementation over the past 20 years of the 3R's principle for batch release at the Scientific Institute of Public Health, Belgium (IPH).
the manufacturer, is ongoing to set a more humane endpoint for the execution of the lethal challenge potency assays for tetanus and pertussis. The ideal situation however would be the replacement of the ...