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

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

6:15 PM — 6:45 PM

Session 8: Closing Remarks

6:45 PM — 6:45 PM

Conference Adjourns

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