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Thursday, November 13, 2025
8:00 AM - 8:20 AM
East Coast USA Time
Let's Make a Difference
8:00 AM - 8:20 AM
East Coast USA Time
Let's Make a Difference
Speaker:
Kimberly Belsky
– AFDO/RAPS Healthcare Products Collaborative
8:20 AM - 9:05 AM
East Coast USA Time
The Solutions Exchange
8:20 AM - 9:05 AM
East Coast USA Time
The Solutions Exchange
Moderator:
Tine Schroder-Albeck
– ALK A/S
Moderator:
Khaudeja Bano
– Genentech/Roche
9:10 AM - 9:55 AM
East Coast USA Time
From the Desk of the Office of Combination Products - Strategic Priorities
9:10 AM - 9:55 AM
East Coast USA Time
From the Desk of the Office of Combination Products - Strategic Priorities
Moderator:
Kimberly Belsky
– AFDO/RAPS Healthcare Products Collaborative
9:55 AM - 10:20 AM
East Coast USA Time
BREAK
9:55 AM - 10:20 AM
East Coast USA Time
BREAK
10:20 AM - 11:20 AM
East Coast USA Time
Global Harmonization in the Diverging Combination Products Space
10:20 AM - 11:20 AM
East Coast USA Time
Global Harmonization in the Diverging Combination Products Space
Moderator:
Susan Neadle
– Combination Products Consulting, LLC
11:25 AM - 12:25 AM
East Coast USA Time
Clinical Investigations for Combined Use Systems
11:25 AM - 12:25 AM
East Coast USA Time
Clinical Investigations for Combined Use Systems
12:25 PM - 1:40 PM
East Coast USA Time
LUNCH
12:25 PM - 1:40 PM
East Coast USA Time
LUNCH
1:40 PM - 2:25 PM
East Coast USA Time
Challenges and Opportunities in Advancing the Use of AI Technologies Across the Combination Product and Combined Use Lifecycle
1:40 PM - 2:25 PM
East Coast USA Time
Challenges and Opportunities in Advancing the Use of AI Technologies Across the Combination Product and Combined Use Lifecycle
Moderator:
Ryan Hoshi
– Abbvie, Inc.
2:30 PM - 3:30 PM
East Coast USA Time
Under Control: Combination Products Control Strategies and Best Practices
2:30 PM - 3:30 PM
East Coast USA Time
EDDO Combination Product Control Strategies and Best Practices
Moderator:
Rumi Young
– Novo Nordisk
3:30 PM - 3:55 PM
East Coast USA Time
BREAK
3:30 PM - 3:55 PM
East Coast USA Time
BREAK
3:55 PM - 4:55 PM
East Coast USA Time
Challenges of Supplier & Partner Relationships
3:55 PM - 4:55 PM
East Coast USA Time
Challenges of Supplier & Partner Relationships
Moderator:
Jason Lipman
– Sanofi
4:55 PM - 5:05 PM
East Coast USA Time
Close Out
4:55 PM - 5:05 PM
East Coast USA Time
Close Out
Moderator:
Kimberly Belsky
– AFDO/RAPS Healthcare Products Collaborative
5:30 PM - 7:00 PM
East Coast USA Time
Networking Reception
5:30 PM - 7:00 PM
East Coast USA Time
Networking Reception