アジェンダ
7:30 AM — 8:30 AM
8:30 AM — 8:45 AM
Introduction and Pre-Recorded Session 1: Drug Development: An Overview8:45 AM — 9:00 AM
Session 2: The IND – A General Introduction9:00 AM — 9:45 AM
Session 3: The IND in Detail - Modules 1, 2, and 59:45 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 - Module 312:30 PM — 1:30 PM
1:30 PM — 2:15 PM
Session 6: The IND in Detail - Modules 4 and 52:15 PM — 2:45 PM
Session 7: The IND in Detail - Additional Topics2:45 PM — 3:15 PM
3:15 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 and Future Amendments4:30 PM — 5:00 PM
Session 10: IND Amendments and Maintenance5:30 PM — 7:45 PM
7:30 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 — 11:00 AM
11:00 AM — 11:45 AM
Session 13: Reporting Adverse Events (AEs) During Clinical Trials11:45 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 — 3:00 PM
3:00 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 Format9:00 AM — 10:30 AM
Session 17: The NDA in CTD Format: How to Submit and Action on Applications10:30 AM — 11:00 AM
11:00 AM — 12:00 PM
Session 18: The FDA and Risk Management12:00 PM — 1:00 PM
1:00 PM — 2:15 PM
Session 19: Regulatory Requirements for Prescription Drug Labeling2:15 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 — 12:45 PM
Session 24: Mock FDA Meeting12:45 PM — 1:45 PM
3:00 PM — 3:30 PM
4:30 PM — 5:00 PM
Feedback and Wrap Up