Please find the session links next to their corresponding agenda item.
Prerecorded
Overview of FDA and Regulatory Processes
Michelle Divelbiss, Associate, Covington & Burling LLP
Watch this session here.
Wednesday, October 26
11:00 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
Enter this session: https://fdli.zoom.us/j/83568211779
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.
Enter this session: https://fdli.zoom.us/j/83568211779
12:20–12:30 PM
Break
12:30– 1:45 PM
Regulation of Biological/Product Development
Elizabeth Trentacost, Associate, Arnold & Porter LLP
Enter this session: https://fdli.zoom.us/j/84254502863
1:45–1:55 PM
Break
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
Enter this session: https://fdli.zoom.us/j/84801644436
3:10–3:20 PM
Break
3:20–4:35 PM
Biological Product Approval, Vaccines, Emergency Use Authorization
Jessica Greenbaum, Counsel, King & Spalding LLP
Eva Temkin, Partner, King & Spalding LLP
Enter this session: https://fdli.zoom.us/j/88352166076
CLE Information
Ohio
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.
Virginia
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 www.vsb.org. 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.