Full Schedule

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

Moderator: – AstraZeneca

Moderator: – ALK A/S

Moderator: – Genentech/Roche

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

From the Desk of the Office of Combination Products - Strategic Priorities

Moderator: – AFDO/RAPS Healthcare Products Collaborative

Speaker: – FDA

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

Moderator: – ALK A/S

Moderator: – Pfizer

Speaker: – Roche Diagnostics (Virtual)

Speaker: – Novo Nordisk

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)

Moderator: – Sanofi

Speaker: – Genentech/Roche

Speaker: – Sanofi

2:00pm - 3:00pm East Coast USA Time

The New Frontier: Evolving Pharma Capabilities for Standalone Devices

Moderator: – Genentech/Roche

Speaker: – FDA

Speaker: – FDA (Invited)

Speaker: – AbbVie, Inc.

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.

Moderator: – AstraZeneca

Speaker: – FDA

Speaker: – FDA (Invited)

Speaker: – Barr Consulting LLC

4:30pm - 5:15pm East Coast USA Time

Right Dose, Real Impact: Strategies to Ensure Consistent Dose for Every Patient

Moderator: – Genentech/Roche

Moderator: – Eli Lilly

Speaker: – FDA

5:20pm - 5:30pm East Coast USA Time

Day 1 Close-Out

Moderator: – AFDO/RAPS Healthcare Products Collaborative

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

Networking Reception