Overview of ICH E2F – Development …

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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 DSURs2Background 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 DSURs3ICH E2F Et W kiGICH E2F Expert Working GroupTimelines Final Concept Paper: September 20

Overview of ICH E2F – Development SafetyDevelopment Safety Update Report (DSUR) International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

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