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Full Schedule

Full Schedule

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Tuesday, November 17, 2026
7:00am - 8:00am East Coast USA Time
Breakfast

7:00am - 5:00pm East Coast USA Time
Registration

8:00am - 8:20am East Coast USA Time
Let's Make A Difference

8:20am - 9:05am East Coast USA Time
The Solutions Exchange

9:10am - 9:40am East Coast USA Time
From the Desk of the Office of Combination Products - Strategic Priorities

9:40am - 10:05am East Coast USA Time
Break

10:05am - 10:20am East Coast USA Time
Workshop Readout

10:25am - 11:25am East Coast USA Time
Evolving European Union Legislation, Regulation, and Policy for Integral Drug-Device Combinations

11:25am - 12:55pm East Coast USA Time
LUNCH

12:55pm - 1:55pm East Coast USA Time
Clinical Investigations for Combined Use Systems (2026 update)

2:00pm - 3:00pm East Coast USA Time
The New Frontier: Evolving Pharma Capabilities for Standalone Devices

3:00pm - 3:25pm East Coast USA Time
BREAK

3:25pm - 4:25pm East Coast USA Time
10 Years Since US Combination Product cGMP Regulations: Reflections on Requirements, Expectations, and Enforcement.

4:30pm - 5:15pm East Coast USA Time
Right Dose, Real Impact: Strategies to Ensure Consistent Dose for Every Patient

5:20pm - 5:30pm East Coast USA Time
Day 1 Close-Out

5:30pm - 6:30pm East Coast USA Time
Networking Reception