Table of Contents Table of Contents Title and Copyright Information Preface Documentation accessibility Diversity and Inclusion Related resources Access to Oracle Support 1 Revision history 2 Introduction 3 Set up reporting destinations to send E2B(R3) report Configure EDI for EMA and PMDA Configure EDI for FDA Configure Studies for FDA IND or Pre-ANDA reporting Configure expedited rules 4 Configure parameters for E2B(R3) reports 5 Customize E2B(R3) profiles