Agenda

subject to change
All times are in Eastern Time

2023 Curriculum Advisor:
Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP

Preconference Primer

Preconference Primer (Virtual)
Overview of FDA and Regulatory Processes
Steven S. Tjoe, Partner, Goodwin Procter LLP
Elizabeth Mulkey, Associate, Goodwin Procter LLP

Wednesday, October 18

11:00 AM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

11:05 AM–12:20 PM
Introduction to FDA Review and Approval of Biological Products

Rebecca Williams, Senior Associate, Ropes & Gray LLP

12:20–12:35 PM
Break

12:35–1:50 PM
Regulation of Biological/Product Development

Matthew Hegreness, Partner, Covington & Burling LLP

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

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

Thursday, October 19

11:00 AM
FDLI Welcome and Announcements

Khara L. Minter, Assistant Director, Training Programs, FDLI

11:05 AM–12:20 PM
Biosimilar Biological Products

Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP

12:20–12:30 PM
Break

12:30–1:30 PM
Post-Approval Pharmacovigilance

Nathan A. Beaver, Partner, Foley & Lardner LLP
Kyle Y. Faget, Partner, Foley & Lardner LLP

1:30–1:40 PM
Break

1:40–2:40 PM
Regulation of Biological Manufacturing

Seth Olson, Associate, Latham & Watkins LLP

2:40–2:50 PM
Break

2:50–3:50 PM
Regulation of Biological Product Marketing

Jur Strobos, Partner, Potomac Law Group

3:50–4:00 PM
Break

4:00–5:00 PM
Violations, Enforcement, and International Issues
Mark C. Levy, Partner, Eckert Seamans Cherin & Mellott, LLC

5:00 PM
Adjournment