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Opening Remarks
Overview of ICH
Updates on ICH Efficacy Related Guidelines: M12, Drug Interaction Studies
E2D(R1), Post-Approval Safety Data Management: Definitions and Standards for Management and Reporting of Individual Case Safety Reports
E6(R3) Good Clinical Practice Principles and Annex 1
M14, General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines
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