Please find the session links next to their corresponding agenda item.
Preconference Primers
Overview of Drug Law and Regulation
Nathan Beaton, Associate, Latham & Watkins LLP
Meryl E. Bartlett, Associate, Latham & Watkins LLP
The New Drug Approval Process: Basic Concept
Alexandre Gapihan, Associate, Morgan, Lewis & Bockius LLP
Tuesday, November 9
11:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI
Enter this session: https://fdli.zoom.us/j/89389495894
11:05 AM – 12:15 PM
The New Drug Approval Process: New Drug Research and Development
Marc Wagner, Associate, BakerHostetler
Enter this session: https://fdli.zoom.us/j/89389495894
12:15 – 1:00 PM
FDA’s COVID-19 Activities
Angela M. Seaton, Partner, Shook, Hardy & Bacon LLP
Enter this session: https://fdli.zoom.us/j/89586226695
1:00 – 1:15 PM
Break
1:15 – 2:25 PM
The New Drug Approval Process: NDA Submission and Review
Elizabeth Mulkey, Senior Associate, Goodwin Procter LLP
Enter this session: https://fdli.zoom.us/j/84092294087
2:25 – 3:35 PM
The Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues
Rebecca L. Dandeker, Partner, Morgan, Lewis & Bockius, LLP
Enter this session: https://fdli.zoom.us/j/87994433584
3:35 – 3:50 PM
Break
3:50 – 5:00 PM
Post-Approval Issues
Frederick A. Stearns, Partner, Kellerand Heckman LLP
Enter this session: https://fdli.zoom.us/j/81131906742