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DIA/FDA Complex Generic Drug-Device Combination Products Conference

Agenda

Day 1 Oct 19, 2020

10:00 AM — 10:45 AM Welcome, Opening Remarks and Session 1: Keynote Address
10:55 AM — 12:40 PM Session 2: Overview of Complex Generic Drug-Device Combination Product Regulation
12:40 PM — 1:00 PM Break
1:00 PM — 2:45 PM Session 3: Bioequivalence and Quality Considerations for Inhalation and Nasal Drug-Device Combination Products
2:45 PM — 3:15 PM Break
3:15 PM — 5:15 PM Session 4: Considerations for Development and Regulatory Review for Injection Devices

Day 2 Oct 20, 2020

10:00 AM — 11:35 AM Welcome to Day 2 and Session 5A: Considerations for Demonstrating Bioequivalence for Generic Intravaginal Rings and Intrauterine Systems
11:35 AM — 12:00 PM Break
12:00 PM — 1:30 PM Session 5B: Intravaginal-Ring and Intrauterine-System Product Development and Quality Considerations
1:30 PM — 2:00 PM Break
2:00 PM — 4:00 PM Session 6: Complex Topical and Transdermal Drug-Device Combination Products
4:00 PM — 4:30 PM Break
4:30 PM — 6:15 PM Session 7: Challenges and Opportunities in Post Marketing Pharmacovigilance and Lifecycle Management for Complex Generic Drug-Device Combination Products
6:15 PM — 6:45 PM Session 8: Closing Remarks
6:45 PM — 6:45 PM Conference Adjourns