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Search results with tag "Clinical evaluation of vaccines"
FIRST DRAFT Guideline on clinical evaluation of …
www.ema.europa.euGuideline on clinical evaluation of vaccines EMEA/CHMP/VWP/164653/05 Rev. 1 Page 3/21 59 Executive summary 60 This guideline addresses the clinical evaluation of vaccines intended for the prevention of infectious
Annex 1 Guidelines on clinical evaluation of vaccines ...
www.who.int35 G Annex 1 Guidelines on clinical evaluation of vaccines: regulatory expectations This document provides guidance for national regulatory authorities and vaccine manufacturers on the clinical evalu-
Guidelines on Clinical Evaluation of Vaccines: Regulatory ...
www.who.intWHO/DRAFT/27 January 2016 Page 7 159 1. Introduction 160 161 This guideline is intended to replace WHO Technical Report, Series No. 924, Annex 1 Guidelines 162 on clinical evaluation of vaccines: Regulatory Expectations, which was adopted by the Expert 163 Committee on Biological Standardization (ECBS) in 2001 (1).