Agenda
7:30 AM — 8:00 AM
8:00 AM — 8:30 AM
8:30 AM — 9:00 AM
SESSION 1: THE IND – A GENERAL INTRODUCTION9:00 AM — 9:45 AM
SESSION 2: THE IND IN DETAIL – MODULES 1, 2, & 59:45 AM — 10:00 AM
10:00 AM — 11:15 AM
SESSION 3: SPECIAL TOPICS FOR CLINICAL RESEARCH UNDER AN IND11:15 AM — 12:00 PM
SESSION 4: IND IN DETAIL – MODULE 312:00 PM — 1:00 PM
1:00 PM — 1:45 PM
SESSION 5: IND IN DETAIL – MODULES 4 & 51:45 PM — 2:15 PM
SESSION 6: IND IN DETAIL – ADDITIONAL TOPICS2:15 PM — 2:45 PM
SESSION 7: FDA’S ACTIONS ON THE ORIGINAL IND & FUTURE AMENDMENTS2:45 PM — 3:00 PM
3:00 PM — 4:00 PM
SESSION 8: ACTIVITIES AND SUBMISSIONS AFTER THE ORIGINAL IND4:00 PM — 5:00 PM
SESSION 9: IND AMENDMENT WORKSHOP5:00 PM — 6:00 PM
8:30 AM — 9:45 AM
SESSION 10: SPECIAL REGULATORY CONSIDERATIONS FOR DEVELOPMENT9:45 AM — 10:45 AM
SESSION 11: REPORTING ADVERSE EVENTS (AES) DURING CLINICAL TRIALS10:45 AM — 11:00 AM
11:00 AM — 12:00 PM
SESSION 12: THE FDA AND RISK MANAGEMENTHave an account?