アジェンダ
9:00 AM — 9:45 AM
9:45 AM — 9:55 AM
9:55 AM — 10:30 AM
Session 1: Opening Remarks10:30 AM — 11:00 AM
Session 2: An Overview of the ANDA Review Process11:00 AM — 11:15 AM
11:15 AM — 12:45 PM
Session 3: Major CMC Deficiencies in ANDA Applications12:45 PM — 1:45 PM
1:45 PM — 2:15 PM
Session 4: BE Considerations in Formulation Development2:15 PM — 3:00 PM
Session 5: Overview of Product Specific Inspections3:00 PM — 3:15 PM
3:15 PM — 3:45 PM
Session 6: Quality expectations for ANDA submissions4:45 PM — 5:00 PM
Session 8: Wrap up9:30 AM — 10:15 AM
Session 1: ANDA First Cycle Approvals10:15 AM — 10:45 AM
Session 2: Best Practices for ANDAs and Refuse to Receive (RTR) Statistics10:45 AM — 11:00 AM
11:00 AM — 11:30 AM
Session 3: Best Practices for ANDA Supplements11:30 AM — 12:30 PM
Session 4: Post approval changes to ANDA12:30 PM — 1:30 PM
1:30 PM — 2:30 PM
Session 5: Knowledge-Aided Assessment and Structured Application (KASA)3:30 PM — 3:45 PM
3:45 PM — 4:45 PM
Session 7: Ask me anything4:45 PM — 5:00 PM
Session 8: Closing Remarks & Thanks