Transcription of ICH E2C(R2) PERIODIC BENEFIT-RISK EVALUATION …
1 ICH E2C(R2) PERIODIC BENEFIT-RISK EVALUATION report (PBRER) 2012 7 25 ICH 2012 1 ICH E2C(R2) EU 2012 PSUR ICH 2 ICH E2C ICH E2C(R2) 2010 11 Brain Storming Session 2011 2 2011 6 ICH 2011 11 ICH 2012 2 STEP2 500 2012 6 ICH 3 ICH Efficacy/Effectiveness PBRER non-ICH Off-label use PBRER Reference Information CCDS CCDS CCSI 4 All available Information Non-interventional Full study report MHLW OK MHLW / 5
2 EU 2012 7 PSUR / 6 US Paperwork Reduction Act STEP4 6 Paperwork Reduction Act 1980 12 11 Pub. L. 96-511 PBRER E2E E2F Gap Analysis 2012 11 Fix 7 8 PSUR PSUR STEP4 9 E2C Scope Out 2010 PSUR EU HL7 2012 2013 Ballot 10 PASS EU 11 - Q.
3 - A. ICH E2C 12 Q. DSUR RMP 13 14
