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Overview of ICH E2F Development SafetyDevelopment Safety Update Report (DSUR)International Conference on Harmonisation of TechnicalRequirements for Registration of Pharmaceuticals for Human UseAgenda Background Information Development Safety Update Report: Existing Situation Opportunities for Improvement General Principles of the DSUR Anticipated Challenges in Implementing DSURs2 Background Information CIOMS VI Management of Safety Information from clinical Trials (2005) Annual Annual Cover entire Development program common international birthdate CIOMS VIIThe Development Safety Update Report: CIOMS VII The Development Safety Update Report: Harmonizing the Format and Content for Periodic Safety Reporting During clinical Trials (2006) Defined detail of contents format timing Defined detail of contents, format, timing General principles re: administrative matters, technical content Example DSURs3 ICH E2F Et W kiGICH E2F Expert Working GroupTimelines Final Concept Paper: September 20, 2006 1stICH Meeting: Oct 2006 (Chicago) 2ndICH Meeting: Oct/Nov 2007 (Yokohama) St2 dt J2008 (P tl d) Step 2 document: June 2008 (Portland) Step 3 consultation/comment period: June December 2008 Step 4 document: August 20104 SCtit/PiilSome Constraints/Principles ICH documents are guidelines, and cannot impose new regulatory requirements.
Background Information CIOMS VI – Management of Safety Information from Clinical Trials (2005) Annual Cover entire development program Common international birthdate
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