Public Meeting - Preparation for the ICH Meetings and ICH 6 
Conference in Osaka, Japan, November 12-15, 2003 

• Introductory Remarks

• ICH General Overview

• CTD/eCTD Implementation Status

• CDER-CBER perspective

• eCTD

• Update on New and On-Going Topics

• S7B/E14: Non-Clinical and Clinical Part of Q-T prolongation

• Pharmacovigilance: E2D, E2E

• GMPs: Pharmaceutical Development, Risk Management

• Gene therapy

• Drug Coding Dictionary

• Q5E

• Update on MedDRA

Date created: October 17, 2003; Updated October 27, 2003

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