Why Attend

Last Year’s Agenda

Location & CLE

Subject to change

All times listed are in Eastern Time

2022 Curriculum Advisor:
Catherine M. Cook, Executive Vice President, Drugs and Biological Products, Greenleaf Health, Inc.

 

Preconference Primer

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

Wednesday, March 16, 2022

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
Catherine M. Cook, Principal for Regulatory Policy, Greenleaf Health, Inc.

12:20–12:30 PM
Break

12:30–1:45 PM
Regulation of Biological/Product Development
Christopher M. Mikson, Partner, DLA Piper LLP

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

3:10–3:20 PM
Break

3:20–4:35 PM
Biological Product Approval, Vaccines, Emergency Use Authorization
Christina M. Markus, Partner, King & Spalding LLP
Eva Temkin, Partner, King & Spalding LLP

 

 

Thursday, March 17, 2022

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

11:05–12:20 PM
Biosimilar Biological Products
Michelle Divelbiss, Associate, Covington & Burling LLP

12:20–12:30 PM
Break

12:30–1:15 PM
Post-Approval Pharmacovigilance
Abeba Habtemariam, Counsel, Arnold & Porter LLP

1:15–1:25 PM
Break

1:25–2:25 PM
Regulation of Biological Manufacturing
Neil Di Spirito, Partner, Brown Rudnick LLP

2:25–2:35 PM
Break

2:35–3:35 PM
Regulation of Biological Product Marketing
Sarah Blankstein, Associate, Ropes & Gray LLP

3:35–3:45 PM
Break

3:45–5:00 PM
Violations, Enforcement, and International Issues
Brian J. Malkin, Partner,McDermott Will & Emery

5:00 PM
Adjournment