Preconference Primers
Preconference Primer (Virtual) (60 Minutes)
Origins and Overview of the Food and Drug Administration and the Regulation of Drugs
Samantha Hong, Associate, Kleinfeld, Kaplan & Becker LLP
Preconference Primer (Virtual) (45 Minutes)
The New Drug Approval Process: Basic Concepts
Jason F. Conaty, Counsel, Global Regulatory, Hogan Lovells US LLP
Wednesday, November 15
11:00 AM
FDLI Welcome and Announcements
Bianca Cardona Melendez, Assistant Director, Educational Programs, FDLI
11:05 AM–12:15 PM
The New Drug Approval Process: New Drug Research and Development
Justin A. Coen, Partner, Venable LLP
12:15 PM–12:30 PM
Break
12:30–1:50 PM
The New Drug Approval Process: NDA Submission and Review
Elizabeth Mulkey, Associate, Goodwin & Proctor 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
Joshua Weinger, Partner, Goodwin Procter LLP
3:25–3:40 PM
Break
3:40–5:00 PM
Post-Approval Issues
Andrew Papas, Vice President of Regulatory Affairs, Pharma Biotech, NSF International
Thursday, November 16
11:00 AM
FDLI Welcome and Announcements
Bianca Cardona Melendez, Assistant Director, Educational Programs, FDLI
11:05 AM–12:05 PM
Biologics and Biosimilars
Khailee Marischuk, Law Graduate, Foley & Lardner LLP
David L. Rosen, Partner, Foley & Lardner LLP
12:05–12:20 PM
Break
12:20–1:20 PM
Regulation of Over-the-Counter (OTC) Drugs
Hillary Nicholas, Shook, Hardy & Bacon LLP
1:20–1:35 PM
Break
1:35–2:35 PM
Regulation of Drug Manufacturing
Paula R. Katz, Of Counsel, Covington & Burling LLP
2:35–2:50 PM
Break
2:50–3:50 PM
Regulation of Drug Marketing
Alan G. Minsk, Partner and Co-Chair of Food and Drug Practice Team, Arnall Golden Gregory LLP
Laura S. Dona, Associate, Arnall Golden Gregory LLP
3:50–4:00 PM
Break
4:00–5:00 PM
Violations and Enforcement
Howard Sklamberg, Partner, Arnold & Porter
5:00 PM
Adjournment
