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Hyatt Regency Bethesda

Oct 19, 2015 7:00 AM - Oct 20, 2015 4:30 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

Biosimilars 2015

Interact with FDA and international agencies to discuss the latest updates and outlooks for biosimilar regulation, while examining the potential implications for patients and HCPs.

Agenda

7:30 AM — 8:30 AM

Registration & Continental Breakfast

8:30 AM — 9:00 AM

Welcome & Opening Remarks

9:00 AM — 10:45 AM

Session 1: Biosimilars in the US & Europe

10:45 AM — 11:15 AM

Refreshment Break

11:15 AM — 12:30 PM

Session 2: Quality Considerations - Part One

12:30 PM — 1:45 PM

Luncheon

1:45 PM — 3:00 PM

Quality Considerations - Part 2: Panel Discussion

3:00 PM — 3:30 PM

Refreshment Break

3:30 PM — 4:45 PM

Session 3: Clinical and Pharmacology Considerations

4:45 PM — 5:45 PM

Networking Reception

7:30 AM — 8:30 AM

Registration & Continental Breakfast

8:30 AM — 10:00 AM

Session 4: Unique Features of Developing Biosimilars in Oncology

10:00 AM — 10:15 AM

Refreshment Break

10:15 AM — 12:15 PM

Session 5: Global Regulatory Policies

12:15 PM — 1:15 PM

Luncheon

1:15 PM — 2:45 PM

Session 6: Pushing Well Forward - Commercialization of Biosimilars Post-2020

2:45 PM — 4:15 PM

Session 7: Interchangeability

4:15 PM — 4:30 PM

Final Q&A and Wrap-up

4:30 PM — 4:30 PM

Meeting Adjourned

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