Day 2


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

Thursday, October 27

11:00 AM 

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

Enter this session:

11:05 AM–12:20 PM 

Biosimilar Biological Products
William Holtz, Principal, Leavitt Partners, LLC

Enter this session:

12:20–12:30 PM 


12:30–1:15 PM 

Post-Approval Pharmacovigilance
Nathan A. Beaver
, Partner, Foley & Lardner LLP

Enter this session:

1:15–1:25 PM


1:25–2:25 PM

Regulation of Biological Manufacturing
Christopher Fanelli
, Partner, Sidley Austin LLP

Enter this session:

2:25–2:35 PM


2:35–3:35 PM

Regulation of Biological Product Marketing
Nathan A. Beaton, Associate, Latham & Watkins LLP
Kathryn Culver, Associate, Latham & Watkins LLP

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3:35–3:45 PM


3:45–5:00 PM

Violations, Enforcement, and International Issues
Rebecca Williams, Associate, Ropes & Gray LLP

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5:00 PM


CLE Information


This event is pending approval in Ohio. To obtain credit, please email [email protected] at the end of the conference and include your state bar number along with how many credits you wish to obtain. FDLI will certify your attendance for you. An evaluation and completed quiz is required to obtain credit.


This event is pending approval in Virginia. Please email [email protected] to request a Virginia form. You will need to certify your attendance online at Retain the Certificate of Attendance for two years.

Other States

These CLE approvals may also be honored by other states; please check with your bar association for guidance. At the end of the conference, please email [email protected] to receive a certificate of attendance.