Transcription of ICH M2 EWG - ESTRI
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ICH M2 EWG - ESTRI
ICH ectd specification V 16-July-2008. INTERNATIONAL CONFERENCE ON HARMONISATION OF. TECHNICAL REQUIREMENTS FOR REGISTRATION OF. PHARMACEUTICALS FOR HUMAN USE. ICH M2 EWG. Electronic Common Technical Document specification This specification has been developed by the ICH M2 Expert Working Group and maintained by the ectd Implementation Working Group in accordance with the ICH Process as pertains to the M2 EWG and ectd . change control as it pertains to the ectd IWG. ICH ectd specification V 16-July-2008. Document Change History Version Date Description Number Version October 2003 Initial Step 4 Document Version November 2003 Incorporated approved change requests 00020, 00030, 00090, 00110, 00190, 00200, 00240, 00260, 00290, 00310, 00380, 00400, 00420, 00450, 00480, 00500, 00510, 00520, 00530. Version February 2004 Editorial Corrections and Changes to Align with the M4 Organisation Document : Granularity Annex Version June 2008 Incorporated approved change requests 0120, 0130, 0140, 0210, 0270, 0300, 0390, 0560, 0590, 0600, 0620, 0640, 0670, 0700, 0710, 0720, 0730, 0750, 0760, 0770, 0780, 0810, 0820, 0940, 0960, 1030, 1080, 01170, 1250, 1280, 1310, 1320, 1360, 1370, 1400, 1450, 1580, 1660, 1680.
ich ectd specification v 3.2. 2 16-july-2008 international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use
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