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Search results with tag "Regulatory expectations"

Annex 1 Guidelines on clinical evaluation of vaccines ...

Annex 1 Guidelines on clinical evaluation of vaccines ...

www.who.int

35 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-

  Evaluation, Regulatory, Clinical, Vaccine, Expectations, Clinical evaluation of vaccines, Regulatory expectations

Guidelines on Clinical Evaluation of Vaccines: Regulatory ...

Guidelines on Clinical Evaluation of Vaccines: Regulatory ...

www.who.int

WHO/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).

  Evaluation, Regulatory, Clinical, Vaccine, Expectations, Clinical evaluation of vaccines, Regulatory expectations

(May 2016) 3 DRAFT FOR COMMENTS - World Health …

(May 2016) 3 DRAFT FOR COMMENTS - World Health

www.who.int

6 Working document QAS/16.666 page 6 130 equipment, utilities and systems, and analytical methods) are included. 131 132 1.3 The following principles apply: 133 134 the execution of validation should be in compliance with 135 regulatory expectations; 136 quality, safety and efficacy must be designed and built into the 137 product; 138 quality cannot be inspected or …

  Draft, Health, 2016, World, Regulatory, World health, 3 draft for comments, Comments, Expectations, Regulatory expectations

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