Why Attend

Agenda

Location & CLE

subject to change
All times listed are in Eastern Time

2022 Curriculum Advisor:
Rebecca L. Dandeker, Partner, Morgan, Lewis & Bockius LLP

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