Agenda
7:30 AM — 8:00 AM
8:00 AM — 8:15 AM
8:15 AM — 9:00 AM
Session 1: Drug Development: An Overview9:00 AM — 9:15 AM
Session 2: The IND – A General Introduction9:15 AM — 10:00 AM
Session 3: The IND in Detail - Items 1-610:00 AM — 10:15 AM
10:15 AM — 12:00 PM
Session 4: Special Topics for Clinical Research12:00 PM — 12:30 PM
Session 5: IND in Detail - Item 712:30 PM — 1:30 PM
1:30 PM — 2:15 PM
Session 6: The IND in Detail - Items 8-102:15 PM — 2:45 PM
Session 7: The IND in Detail - Additional Topics2:45 PM — 3:00 PM
3:00 PM — 4:00 PM
Session 8: Quality Assurance in Drug Development (GxPs)4:00 PM — 4:30 PM
Session 9: FDA's Actions on the Original IND & Future Amendments4:30 PM — 5:00 PM
Session 10: IND Amendments and Maintenance7:30 AM — 8:00 AM
8:00 AM — 8:30 AM
Session 10: IND Amendments and Maintenance (continued)8:30 AM — 9:30 AM
Session 11: Workshop - IND Amendment9:30 AM — 10:30 AM
Session 12: Special Regulatory Considerations for Development10:30 AM — 11:15 AM
Session 13: Reporting Adverse Events (AEs) during Clinical Trials11:15 AM — 12:30 PM
Session 14: Workshop: AE Reporting12:30 PM — 1:30 PM
1:30 PM — 2:30 PM
Session 15: The NDA in CTD Format: Types of NDAs2:30 PM — 2:45 PM
2:45 PM — 5:00 PM
Session 16: The NDA in CTD Format: Modules 1-57:30 AM — 8:00 AM
8:00 AM — 9:00 AM
Session 16: The NDA in CTD Format (continued)9:00 AM — 10:30 AM
Session 17: The NDA in CTD Format: How to Submit and Action on Applications10:30 AM — 10:45 AM
10:45 AM — 11:45 AM
Session 18: The FDA and Risk Management11:45 AM — 12:45 PM
12:45 PM — 2:00 PM
Session 19: Regulatory Requirements for Prescription Drug Labeling2:00 PM — 3:30 PM
Session 20: Post-NDA Approval Regulatory Requirements4:30 PM — 5:00 PM
Preparation for Mock FDA Meeting7:30 AM — 8:00 AM
8:00 AM — 9:15 AM
Session 22: Interactions with FDA - Part 19:15 AM — 10:30 AM
Session 23: Interactions with FDA - Part 210:30 AM — 10:45 AM
10:45 AM — 12:30 PM
Session 24: Mock FDA Meeting12:30 PM — 1:15 PM
2:30 PM — 2:45 PM
4:30 PM — 5:00 PM
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