Transcription of ICH E2B (R3) - jpma.or.jp
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ICH E2B (R3) - jpma.or.jp
ICH E2B (R3) ICH 2010. 2. 17E2B (R3) E2B (R3) SDO Feasibility Testing R3 M2 E2B (R2): M2: 2000 11 ICH Step 42003 10 E2B (R3): M2: SGML XML R3 2003 11 ICH EWG 2004 5 E2B R3 EWG 2005 5 E2B R3 Guideline Step2 2005 7 9 E2B R3 Guideline 2006 6 11 ICH SDO 2007 2 E2B R3 Guideline ver. Step4 2007 3 ICH ISO New Work Item Proposal (NWIP)SDO ICHE2B R3 ver. ICH 2007 10 ICH ISO ICH E2B R3 Guideline ver. HL7 ICSR R2 R3 2008 11 ICH ICH E2B R3 Guideline ver. 2009 4 9 ISO Draft International Standard (DIS) ISO ICH ISOICSR DIS Alfa test 2009 6 ICH Feasibility Testing (Step 2 for Testing) ICH Feasibility Testing ICH ICH 2009 8 ISOICSR DIS ISO 2009 10 ICH E2B R3 E2B(R3) E2B(R2) E2B(R3) E2B(R2) (Safety)
1．背景 2．E2B (R3)における変更点 3．SDOプロセスについて 4．Feasibility Testingについて 2010.2.17 2
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