Day 1

 

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

Overview of FDA and Regulatory Processes
Steven S. Tjoe, Partner, Goodwin Procter LLP
Elizabeth Mulkey, Associate, Goodwin Procter LLP

Watch this session here.

 

 

 

Wednesday, October 18

 

11:00 AM 

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

Enter this session: https://fdli.zoom.us/j/89227884635?pwd=9qi8D4hX492k0LJYbVVdEa82yk0aQB.1

11:05 AM–12:20 PM 

 

Introduction to FDA Review and Approval of Biological Products
Rebecca Williams, Senior Associate, Ropes & Gray LLP

Enter this session: https://fdli.zoom.us/j/89227884635?pwd=9qi8D4hX492k0LJYbVVdEa82yk0aQB.1

 

12:20–12:35 PM 

 

Break

12:35–1:50 PM 

Regulation of Biological/Product Development
Matthew Hegreness, Partner, Covington & Burling LLP

Enter this session: https://fdli.zoom.us/j/86527500210?pwd=Sw5xkWidgzbm4dfC51nJbcPYzN4bTA.1

1:50–2:05 PM

 

Break

2:05–3:20 PM

 

Human Cellular and Tissue Based Products (HCT/P), Cell Therapy and Gene Therapy
Tina Papagiannopoulos, Counsel, Foley Hoag LLP
Matthew Piscitelli, Associate, Foley Hoag LLP

Enter this session: https://fdli.zoom.us/j/83963335384?pwd=8GqdRPiuYoBsKVrFEqFJIaLU75FQi8.1

 

 

3:20–3:35 PM

 

Break

3:35–4:50 PM

 

Biological Product Approval, Vaccines, Emergency Use Authorization
Christina M. Markus, Partner, King & Spalding LLP
Jessica Greenbaum, Counsel, King & Spalding LLP

Enter this session: https://fdli.zoom.us/j/83893256498?pwd=dJZmVHtZdbmW2PpDGeWrCfLbXHbrtO.1

 

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 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.