アジェンダ
7:45 AM — 8:30 AM
8:30 AM — 8:45 AM
Welcome and Introduction8:45 AM — 9:00 AM
Drug Development: Precourse Work Review9:00 AM — 9:15 AM
Session 1: The IND – A General Introduction9:15 AM — 10:00 AM
Session 2: The IND in Detail - Modules 1, 2, and 510:00 AM — 10:30 AM
10:30 AM — 11:00 AM
Session 3: IND in Detail - Modules 3 and 111:00 AM — 12:00 PM
Session 4: The IND in Detail - Modules 4, 5, and 212:00 PM — 1:00 PM
1:00 PM — 1:30 PM
Session 5: The IND in Detail - Additional Topics1:30 PM — 2:15 PM
Session 6: FDA's Actions on the Original IND and Future Amendments2:15 PM — 3:15 PM
Session 7: IND Amendments and Maintenance3:15 PM — 3:30 PM
3:30 PM — 4:30 PM
Session 8: Workshop - IND Amendments4:30 PM — 5:00 PM
Session 9: Special Topics in Clinical Research5:00 PM — 6:00 PM
7:30 AM — 8:00 AM
8:00 AM — 9:00 AM
Session 9: Special Topics for Clinical Research (Continued)9:00 AM — 10:15 AM
Session 10: Special Regulatory Considerations for Development10:15 AM — 10:45 AM
10:45 AM — 11:45 AM
Session 11: Reporting Adverse Events (AEs) During Clinical Trials11:45 AM — 12:45 PM
12:45 PM — 2:00 PM
Session 12: Workshop: AE Reporting2:00 PM — 2:45 PM
Session 13: Quality Assurance in Drug Development (GxPs)2:45 PM — 3:15 PM
3:15 PM — 4:15 PM
Session 14: The NDA in CTD Format: Types of NDAs4:15 PM — 4:45 PM
Session 15: The NDA in CTD Format: Modules 1-54:45 PM — 5:00 PM
Day 2 Closing Activity7:30 AM — 8:00 AM
8:00 AM — 9:45 AM
Session 15: The NDA in CTD Format: Modules 1-5 (Continued)9:45 AM — 10:00 AM
10:00 AM — 11:30 AM
Session 16: NDA Submission, FDA Review, and Action on Applications11:30 AM — 12:00 PM
Session 17: The FDA and Risk Management12:00 PM — 1:00 PM
1:00 PM — 2:15 PM
Session 18: Regulatory Requirements for Prescription Drug Labeling2:15 PM — 3:30 PM
Session 19: Post NDA Approval Regulatory Requirements3:30 PM — 3:45 PM
3:45 PM — 4:45 PM
Session 20: Post-Approval Workshop4:45 PM — 5:00 PM
Preparation for Mock FDA Meeting7:30 AM — 8:00 AM
8:00 AM — 8:45 AM
Session 21: Interactions with FDA - Part 18:45 AM — 10:00 AM
Session 22: Interactions with FDA - Part 210:00 AM — 10:30 AM
10:30 AM — 12:30 PM
Session 23: Mock FDA Meeting12:30 PM — 1:30 PM
2:30 PM — 2:45 PM
3:45 PM — 4:45 PM
Session 26: Resources for Regulatory Intelligence4:45 PM — 5:00 PM
Course Wrap-Up and Closing Activity