アジェンダ

Day 1 2017年10月24日 (火)

7:00 AM — 8:00 AM

Registration, Continental Breakfast, and Networking

8:00 AM — 8:20 AM

Welcoming Remarks

8:20 AM — 8:45 AM

Opening and Introduction to the Conference

8:45 AM — 10:30 AM

Session 1: Emerging Approaches to Demonstrating Structural and Functional Similarity

10:30 AM — 11:00 AM

Networking and Refreshment Break

11:00 AM — 12:30 PM

Session 2: Role of Clinical Trials in Biosimilar Development

12:30 PM — 1:30 PM

Luncheon and Networking

1:30 PM — 2:45 PM

Session 3: Impact of US FDA Final Naming Guidance for Biologics

2:45 PM — 3:30 PM

Session 4: How Will BsUFA II Modify the Development and Approval of Biosimilars in the US?

3:30 PM — 3:45 PM

Networking and Refreshment Break

3:45 PM — 5:30 PM

Session 5: Penetrating the Market

5:30 PM — 6:30 PM

Networking Reception

Day 2 2017年10月25日 (水)

7:00 AM — 8:00 AM

Registration and Continental Breakfast

8:00 AM — 8:10 AM

Opening Remarks

8:10 AM — 10:10 AM

Session 6: Taking the International Pulse: What’s New in the Policy and Regulatory Landscape?

10:10 AM — 10:30 AM

Networking and Refreshment Break

10:30 AM — 11:15 AM

Session 7: Ask the Regulators

11:15 AM — 12:15 PM

Session 8: Postmarketing Phase: Approval is Just the Beginning

12:15 PM — 1:30 PM

Luncheon

1:30 PM — 3:00 PM

Session 9: Interchangeability

3:00 PM — 3:30 PM

Closing Remarks

Biosimilars Conference