Full Schedule

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

Moderator: – AFDO/RAPS Healthcare Products Collaborative

8:10am - 9:10am East Coast USA Time

Global Updates for Drug Delivery

Moderator: – Novo Nordisk

Moderator: – AbbVie, Inc.

Speaker: – Saudi Food and Drug Authority (SFDA) (Invited)

Speaker: – FDA

Speaker: – Anvisa

9:15am - 10:15am East Coast USA Time

Digital Innovation Integrated with Advanced On-Body Drug Delivery Systems (OBDS)

Moderator: – AbbVie, Inc.

Speaker: – Suttons Creek

Speaker: – AbbVie, Inc.

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

Moderator: – Merck

Speaker: – Genentech/Roche

Speaker: – Merck

Speaker: – FDA (Invited)

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

LUNCH

1:10pm - 2:10pm East Coast USA Time

Timely Changes: FDA Expectations and Industry Strategies for Combination Products

Moderator: – Novo Nordisk

Speaker: – Lilly

Speaker: – FDA (Invited)

Speaker: – FDA

Speaker: – AbbVie, Inc.

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

Fireside Chat

Speaker: – FDA

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

Close-Out

Moderator: – AFDO/RAPS Healthcare Products Collaborative