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

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Wednesday, October 18


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
Rebecca Williams, Senior Associate, Ropes & Gray LLP

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12:20–12:35 PM 



12:35–1:50 PM 

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

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1:50–2:05 PM



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

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3:20–3:35 PM



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

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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.