Immunization, Vaccines and Biologicals

WHO/V&B/03.12

Training manual on the critical regulatory function for vaccines : Evaluation of clinical performance through authorized clinical trials

This document has been developed for the Global Training Network as part of the training curricula for strengthening the NRA's critical six functions. It is intended to provide general guidance for the evaluation of clinical data and to give guidance in the decision-making process for the licensing of vaccines new to the country, including new combination vaccines.

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