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Full Schedule

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Monday, November 16, 2026
7:00am - 8:00am East Coast USA Time
Breakfast

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

8:00am - 9:30am East Coast USA Time
Integrated Combination Product Shelf Life Strategy

9:30am - 9:50am East Coast USA Time
BREAK

9:55am - 11:25am East Coast USA Time
Hot Topics For Combination Products

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

12:30pm - 2:00pm East Coast USA Time
Hot Topics For Combination Products

2:05pm - 2:25pm East Coast USA Time
BREAK

2:30pm - 5:00pm East Coast USA Time
Building a Platform Combination Product

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

Wednesday, November 18, 2026
7:00am - 8:00am East Coast USA Time
Breakfast

7:00am - 3:00pm East Coast USA Time
Registration

8:00am - 8:10am East Coast USA Time
Day 2 Opening

8:10am - 9:10am East Coast USA Time
Global Updates for Drug Delivery

9:15am - 10:15am East Coast USA Time
Timely Changes: FDA Expectations and Industry Strategies for Combination Products

10:15am - 10:40am East Coast USA Time
BREAK

10:40am - 12:10pm East Coast USA Time
FDA and Industry Insights: QMSR Impacts on Combination Product Design, Development & Risk and How to Prepare for Compliance

12:10pm - 1:10pm East Coast USA Time
LUNCH

1:10pm - 2:10pm East Coast USA Time
Digital Innovation integrated with advanced On-Body Drug Delivery Systems (OBDS)

2:10pm - 3:10pm East Coast USA Time
Fireside Chat

3:10pm - 3:20pm East Coast USA Time
Close-Out