Full Schedule

7:45 AM - 8:45 AM East Coast USA Time

Breakfast

8:45 AM - 11:30 AM East Coast USA Time

Workshop: Hot Topics for Combination Products

Moderator: – Sanofi

Moderator: – Johnson & Johnson

Speaker: – Novo Nordisk

Speaker: – Genentech

Speaker: – Amgen

Speaker: – Pfizer

Speaker: – AstraZeneca

Speaker: – Eli Lilly

Speaker: – Sanofi

10:00 AM - 10:15 AM East Coast USA Time

BREAK

11:30 AM - 12:30 PM East Coast USA Time

LUNCH

12:30 PM - 3:00 PM East Coast USA Time

Workshop: Unlocking Best Practices for Sponsors and Regulators in Combination Product Submissions

Moderator: – Novo Nordisk

Moderator: – ALK A/S

Moderator: – AbbVie, Inc.

Speaker: – Epstein Becker Green

Speaker: – AbbVie, Inc

Speaker: – FDA

Speaker: – DEKRA Certification B.V.

3:00 PM - 3:15 PM East Coast USA Time

BREAK

3:15 PM - 5:15 PM East Coast USA Time

Workshop: Essential Drug Delivery Output

Moderator: – Combination Products Consulting Services, LLC

Moderator: – Strategic Parenteral Solutions

Speaker: – Merck

Speaker: – AstraZeneca

7:00 AM - 8:00 AM East Coast USA Time

Breakfast

8:00 AM - 8:20 AM East Coast USA Time

Let's Make a Difference

Speaker: – AFDO/RAPS Healthcare Products Collaborative

Speaker: – Association of Food and Drug Officials (AFDO)

Speaker: – Regulatory Affairs Professionals Society (RAPS)

8:20 AM - 9:05 AM East Coast USA Time

The Solutions Exchange

Moderator: – ALK A/S

Moderator: – Genentech/Roche

9:10 AM - 9:55 AM East Coast USA Time

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

Moderator: – AFDO/RAPS Healthcare Products Collaborative

Speaker: – FDA (Invited)

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

Moderator: – Combination Products Consulting Services, LLC

Speaker:

11:25 AM - 12:25 AM East Coast USA Time

Clinical Investigations for Combined Use Systems

Moderator: – ALK A/S

Moderator: – AstraZeneca

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

Moderator: – AbbVie, Inc.

Speaker: – DEKRA

Speaker: – FDA (Virtual)

Speaker: – Covington & Burling

2:30 PM - 3:30 PM East Coast USA Time

EDDO Combination Product Control Strategies and Best Practices

Moderator: – Novo Nordisk

Speaker: – Novo Nordisk

Speaker: – FDA

Speaker: – GSK

Speaker: – Amgen

Speaker: – FDA (Virtual)

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

Moderator: – Sanofi

Speaker: – Sanofi

Speaker: – Becton Dickinson & Co

Speaker: – Enable Injections

4:55 PM - 5:05 PM East Coast USA Time

Close Out

Moderator: – AFDO/RAPS Healthcare Products Collaborative

5:30 PM - 7:00 PM East Coast USA Time

Networking Reception

7:00 AM - 8:00 AM East Coast USA Time

Breakfast

8:00 AM - 8:10 AM East Coast USA Time

Day 2 Opening

Speaker: – AFDO/RAPS Healthcare Products Collaborative

8:10 AM - 9:25 AM East Coast USA Time

Navigating Human Factors for Combination Products, Including Generic: URRA, Threshold Analysis and Post Market

Moderator: – Novo Nordisk

Speaker: – Novo Nordisk

Speaker: – Regeneron

Speaker: – Merck

Speaker: – FDA (Virtual)

9:25 AM - 9:50 AM East Coast USA Time

BREAK

9:50 AM - 10:50 AM East Coast USA Time

Navigating the Post-Market Landscape of Combination Products: Surveillance Best Practices, Risk Management and Change Management

Moderator: – Merck

Speaker: – Lilly

Speaker: – Genentech/Roche

Speaker: – Combination Products Consulting Services, LLC

10:55 AM - 12:10 PM East Coast USA Time

Drug-Delivery Device Clinical Bridging: Leveraging Platform Approach and Prior Knowledge

Moderator: – Genentech/Roche

Speaker: – Genentech

Speaker: – Eli Lilly

Speaker: – Novo Nordisk

12:10 PM - 1:10 PM East Coast USA Time

LUNCH

1:15 PM - 2:30 PM East Coast USA Time

Navigating Clinical Strategies for Combination Products with Investigational Devices

Moderator: – Eli Lilly

Moderator: – AbbVie, Inc.

Speaker: – Suttons Creek

Speaker: – FDA

Speaker: – AbbVie, Inc.

Speaker: – Edgeone Medical

2:35 PM - 3:35 PM East Coast USA Time

FDA Fireside Chat

Moderator: – Sanofi

Moderator: – AstraZeneca

Speaker: – FDA (Invited)

3:35 PM - 3:45 PM East Coast USA Time

Summit Close-Out

Speaker: – AFDO/RAPS Healthcare Products Collaborative