Day 2


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

Thursday, October 19


11:00 AM 

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

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11:05 AM–12:20 PM


Biosimilar Biological Products
Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP

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12:20–12:30 PM 



12:30–1:30 PM 


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

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1:30–1:40 PM



1:40–2:40 PM


Regulation of Biological Manufacturing
Seth Olson, Associate, Latham & Watkins LLP

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2:40–2:50 PM



2:50–3:50 PM


Regulation of Biological Product Marketing
Jur Strobos, Partner, Potomac Law Group

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3:50–4:00 PM



4:00–5:00 PM


Violations, Enforcement, and International Issues
Mark C. Levy, Partner, Eckert Seamans Cherin & Mellott, LLC

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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 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.