Agenda

Preconference Primers

Preconference Primer (Virtual) (60 Minutes)
Overview of Drug Law and Regulation
Jur Strobos, Partner, Potomac Law Group

Preconference Primer (Virtual) (75 Minutes)
The New Drug Approval Process: Basic Concepts
Jennifer A. Davidson, Partner, Kleinfeld, Kaplan & Becker, LLP

Wednesday, November 9

11:00 AM
FDLI Welcome and Announcements

11:05 AM–12:15 PM
The New Drug Approval Process: New Drug Research and Development
Marc Wagner, Associate, BakerHostetler

12:15-12:30 PM

Break

12:30-1:50 PM
The New Drug Approval Process: NDA Submission and Review
Lauren Farruggia, Associate, Goodwin Procter LLP

1:50-2:05 PM
Break

2:05–3:25 PM
The Abbreviated NDA (ANDA), 505(b)(2) Applications, and Patent and Exclusivity Issues
Rebecca L. Dandeker, Partner, Morgan, Lewis & Bockius LLP

3:25–3:40 PM
Break

3:40–5:00 PM
Post-Approval Issues
Lee Rosebush, Partner, BakerHostetler

Thursday, November 10

11:00 AM
FDLI Welcome and Announcements

11:05 AM–12:05 PM
Biologics and Biosimilars
Jacqueline R. Berman, Partner, Morgan, Lewis & Bockius LLP

12:05–12:20 PM
Break

12:20–1:20 PM
Regulation of Over-the-Counter (OTC) Drugs
Benjamin M. Zegarelli, Of Counsel, Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

1:20–1:35 PM
Break

1:35–2:35 PM
Regulation of Drug Manufacturing
Scott Kaplan, Partner, Sidley Austin LLP

2:35–2:50 PM
Break

2:50–3:50 PM
Regulation of Drug Marketing
Stephen E. Nichols, Associate, Shook, Hardy & Bacon LLP

3:50–4:00 PM
Break

4:00–5:00 PM
Violations and Enforcement
Peter J. Leininger, Partner, King & Spalding LLP

5:00 PM
Adjournment