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Wed, Nov 12
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Thursday, November 13, 2025
7:00 AM - 8:00 AM
East Coast USA Time
Breakfast
7:00 AM - 8:00 AM
East Coast USA Time
Breakfast
Location: Narragansett Foyer
7:00 AM - 5:00 PM
East Coast USA Time
Registration
7:00 AM - 5:00 PM
East Coast USA Time
Registration
Location: Narragansett Coatroom
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
Location: Narragansett Ballroom
Speaker:
Kimberly Belsky
– AFDO/RAPS Healthcare Products Collaborative
Speaker:
Steven Mandernach
– Association of Food and Drug Officials (AFDO)
Speaker:
Brian Savoie
– Regulatory Affairs Professionals Society (RAPS)
8:20 AM - 9:20 AM
East Coast USA Time
The Solutions Exchange
8:20 AM - 9:20 AM
East Coast USA Time
The Solutions Exchange
Location: Narragansett Ballroom
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
9:25 AM - 9:55 AM
East Coast USA Time
From the Desk of the Office of Combination Products - Strategic Priorities
Location: Narragansett Ballroom
Moderator:
Kimberly Belsky
– AFDO/RAPS Healthcare Products Collaborative
Speaker:
James Bertram
– FDA (Virtual)
9:55 AM - 10:20 AM
East Coast USA Time
BREAK
9:55 AM - 10:20 AM
East Coast USA Time
BREAK
Location: Narragansett Foyer
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
Location: Narragansett Ballroom
Moderator:
Susan Neadle (she/her/hers)
– Combination Products Consulting Services, LLC
Speaker:
Ashley Boam (she/her/hers)
– FDA (Virtual)
Speaker:
Katie Duncan (she/her/hers)
– GSK
Speaker:
Subhi Saadeh
– Gilead Sciences
Speaker:
John Weiner
– Barr Consulting LLC
Speaker:
Mohammad Alkudsi
– Saudi Food and Drug Authority (SFDA) (Virtual)
11:25 AM - 12:25 AM
East Coast USA Time
Clinical Investigations for Combined Use Systems
11:25 AM - 12:25 PM
East Coast USA Time
Clinical Investigations for Combined Use Systems
Location: Narragansett Ballroom
Moderator:
Tine Schroder-Albeck
– ALK A/S
Moderator:
Ryan McGowan
– AstraZeneca
Speaker:
Tim Chesworth (he/him/his)
– Novartis
Speaker:
Ditte Zerlang Andersen (Virtual)
– Danish Medicines Agency
12:25 PM - 1:40 PM
East Coast USA Time
LUNCH
12:25 PM - 1:40 PM
East Coast USA Time
LUNCH (Click to see information on table topics)
Location: Providence Ballroom Foyer
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
Location: Narragansett Ballroom
Moderator:
Ryan Hoshi
– AbbVie, Inc.
Speaker:
Kathryn Drzewiecki
– FDA (Virtual)
Speaker:
Xia Huang (he/him/his)
– DEKRA
Speaker:
Christina Kuhn
– Covington & Burling
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
Location: Narragansett Ballroom
Moderator:
Rumi Young
– Novo Nordisk
Speaker:
Anna Karina Busch
– Novo Nordisk
Speaker:
Ashley Boam (she/her/hers)
– FDA (Virtual)
Speaker:
Susan Clemmons
– GSK
Speaker:
Willy Liou
– Amgen
Speaker:
Shruti Mistry
– FDA (Virtual)
3:30 PM - 3:55 PM
East Coast USA Time
BREAK
3:30 PM - 3:55 PM
East Coast USA Time
BREAK
Location: Narragansett Foyer
3:55 PM - 4:55 PM
East Coast USA Time
Navigating the Post-Market Landscape of Combination Products: Surveillance Best Practices, Risk Management and Change Management
3:55 PM - 4:55 PM
East Coast USA Time
Navigating the Post-Market Landscape of Combination Products: Surveillance Best Practices, Risk Management and Change Management
Location: Narragansett Ballroom
Moderator:
Jiaying Shen
– Merck
Speaker:
ChiaYee Ang
– Lilly
Speaker:
Khaudeja Bano
– Genentech/Roche
Speaker:
Susan Neadle (she/her/hers)
– Combination Products Consulting Services, LLC
4:55 PM - 5:05 PM
East Coast USA Time
Close Out
4:55 PM - 5:05 PM
East Coast USA Time
Close Out
Location: Narragansett Ballroom
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
Location: Providence Ballroom
