アジェンダ
8:15 AM — 8:30 AM
8:30 AM — 9:00 AM
Session 1: Introduction to Combination Products9:00 AM — 9:30 AM
Session 2: Combination Products by Type9:30 AM — 10:30 AM
Session 3: Determining Regulatory Route for Approval10:30 AM — 10:45 AM
10:45 AM — 11:45 AM
Session 4: Basics for Drug Development11:45 AM — 12:45 PM
12:45 PM — 1:45 PM
Session 5: Basics for Medical Device Development1:45 PM — 2:30 PM
Session 6: Development Specifics for Combination Product2:30 PM — 3:30 PM
Session 7: Manufacturing Compliance for Combination Products3:30 PM — 3:45 PM
3:30 PM — 4:45 PM
Session 8: GMP Workshop4:45 PM — 5:00 PM
Day One Wrap-up/Questions and Answers8:15 AM — 8:30 AM
8:30 AM — 9:30 AM
Session 9: Working with FDA: An Overview9:30 AM — 10:30 AM
Session 10: Post-Approval Changes (CMC, Manufacturing, and Labeling)10:30 AM — 10:45 AM
10:45 AM — 12:00 PM
Session 11: Post-Approval Changes Workshop12:00 PM — 1:00 PM
1:00 PM — 2:00 PM
Session 12: Safety Reporting2:00 PM — 3:30 PM
Session 13: Safety Reporting Workshop3:30 PM — 3:45 PM
3:45 PM — 4:30 PM
Session 14: Advanced Strategies for Combinations4:30 PM — 4:45 PM
Day Two Wrap-up/Questions and Answers