Day 1

Day 2

Resources

Please find the session links next to their corresponding agenda item.

Thursday, March 17

11:00 AM 

FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

Enter this session: https://fdli.zoom.us/j/83326367730

11:05 AM– 12:20 PM 

Biosimilar Biological Products
Michelle Divelbiss, Associate, Covington & Burling LLP

Enter this session: https://fdli.zoom.us/j/83326367730

Download Speakers Slides

12:20 – 12:30 PM 

Break

12:30 – 1:15 PM 

Post-Approval Pharmacovigilance
Abeba Habtemariam, Counsel, Arnold & Porter LLP

Enter this session: https://fdli.zoom.us/j/83574882702 

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1:15 – 1:25 PM

Break

1:25 – 2:25 PM

Regulation of Biological Manufacturing
Neil Di Spirito, Partner, Brown Rudnick LLP

Enter this session: https://fdli.zoom.us/j/85611793888

Download Speakers Slides

2:25 – 2:35 PM

Break

2:35 – 3:35 PM

Regulation of Biological Product Marketing
Sarah Blankstein, Associate, Ropes & Gray LLP

Enter this session: https://fdli.zoom.us/j/88599592476

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3:35 – 3:45 PM

Break

3:45 – 5:00 PM

Violations, Enforcement, and International Issues
Brian J. Malkin, Partner,McDermott Will & Emery

Enter this session: https://fdli.zoom.us/j/89489487983

Download Speakers Slides

5:00 PM

Adjournment

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