アジェンダ
9:00 AM — 9:30 AM
Welcome and Introduction9:30 AM — 10:00 AM
Session 2: Combination Products by Type10:00 AM — 11:00 AM
Session 3: Determining Regulatory Route for Approval11:00 AM — 11:15 AM
11:15 AM — 12:30 PM
Session 4: Regulatory Pathway by Center12:30 PM — 12:45 PM
Wrap up and Questions9:00 AM — 9:15 AM
Welcome and Recap of Part 19:15 AM — 10:30 AM
Session 5: Product Development10:30 AM — 10:45 AM
10:45 AM — 11:30 AM
Session 6: Patient Focus11:30 AM — 12:15 PM
Session 7: Safety Reporting12:15 PM — 1:00 PM
Session 8: Safety Reporting Workshop1:00 PM — 1:15 PM
Wrap-up and Questions9:00 AM — 9:15 AM
Welcome and Recap of Part 29:15 AM — 10:30 AM
Session 9: Working with FDA Review Centers10:30 AM — 10:45 AM
10:45 AM — 11:45 AM
Session 10: Post-Approval Changes (CMC, Manufacturing, and Labeling)11:45 AM — 1:00 PM
Session 11: Post-Approval Changes Workshop1:00 PM — 1:15 PM
Wrap-up and Questions9:00 AM — 9:15 AM
Welcome and Recap of Part 39:15 AM — 10:00 AM
Session 12: Good Manufacturing Practices for Combination Products10:00 AM — 10:15 AM
10:15 AM — 11:00 AM
Session 13: GMP Workshop11:00 AM — 11:15 AM
Wrap-up/Questions and Answers