Transcription of Title: Guidelines for Procedures and Data …
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Title: Guidelines for Procedures and Data …
1 1 2 ENGLISH ONLY 3 4 Guidelines for Procedures and data requirements for changes to 5 approved vaccines 6 7 NOTE: 8 9 This document has been prepared for the purpose of inviting comments and suggestions on the 10 proposals contained therein, which will then be considered by the Expert Committee on 11 Biological Standardization (ECBS). Publication of this early draft is to provide information about 12 the Guidelines for Procedures and data requirements for Changes to Approved Vaccines to a 13 broad audience and to improve transparency of the consultation process. 14 15 These Guidelines were developed based on the outcomes and consensus of the WHO 16 consultation convened in 2013 with participants from national regulatory authorities, national 17 control laboratories, vaccine manufacturers and academia researchers and comments from the 18 public consultation on WHO website in 2014.
1 1 2 WHO/BS.2014.2238 3 ENGLISH ONLY 4 5 Guidelines for procedures and data requirements for changes to 6 approved vaccines 7 8 NOTE: 9 10 This document has been prepared for the purpose of inviting comments and suggestions on the
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