Day 1


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


Overview of FDA and Regulatory Processes
Michelle Divelbiss, Associate, Covington & Burling LLP

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Wednesday, October 26


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 

Introduction to FDA Review and Approval of Biological Products
Jewell Martin, Associate Director for US Regulatory Policy, BioMarin Pharmaceutical Inc.

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12:20–12:30 PM 



12:30– 1:45 PM 

Regulation of Biological/Product Development
Elizabeth Trentacost, Associate, Arnold & Porter LLP

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1:45–1:55 PM


1:55–3:10 PM

Human Cellular and Tissue Based Products (HCT/P), Cell Therapy and Gene Therapy
Gail Javitt, Partner, Hyman, Phelps & McNamara, PC

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3:10–3:20 PM


3:20–4:35 PM

Biological Product Approval, Vaccines, Emergency Use Authorization
Jessica Greenbaum, Counsel, King & Spalding LLP
Eva Temkin, Partner, King & Spalding LLP

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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 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.