Why Attend

Agenda

Location & CLE

Subject to change
All times 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

Wednesday, October 26

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
Jewell Martin, Associate Director for US Regulatory Policy, BioMarin Pharmaceutical Inc.

12:20–12:30 PM
Break

12:30–1:45 PM
Regulation of Biological/Product Development

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

 

Thursday, October 27

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

11:05–12:20 PM
Biosimilar Biological Products
Anne Marie Polak, Senior Director, Leavitt Partners, LLC

12:20–12:30 PM
Break

12:30–1:15 PM
Post-Approval Pharmacovigilance
Nathan A. Beaver, Partner, Foley & Lardner LLP

1:15–1:25 PM
Break

1:25–2:25 PM
Regulation of Biological Manufacturing
Christopher Fanelli, Partner, Sidley Austin LLP

2:25–2:35 PM
Break

2:35–3:35 PM
Regulation of Biological Product Marketing
Nathan A. Beaton, Associate, Latham & Watkins LLP
Kathryn Culver, Associate, Latham & Watkins LLP

3:35–3:45 PM
Break

3:45–5:00 PM
Violations, Enforcement, and International Issues

5:00 PM
Adjournment