Day 1


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

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The New Drug Approval Process: Basic Concept
Alexandre Gapihan, Associate, Morgan, Lewis & Bockius LLP

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11:00 PM 

FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

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11:05 AM – 12:15 PM 

The New Drug Approval Process: New Drug Research and Development
Marc Wagner, Associate, BakerHostetler

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12:15 – 1:00 PM 

FDA’s COVID-19 Activities
Angela M. Seaton, Partner, Shook, Hardy & Bacon LLP

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1:00 – 1:15 PM


1:15 – 2:25 PM

The New Drug Approval Process: NDA Submission and Review
Elizabeth Mulkey, Senior Associate, Goodwin Procter LLP

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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

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3:35 – 3:50 PM


3:50 – 5:00 PM

Post-Approval Issues
Frederick A. Stearns, Partner, Kellerand Heckman LLP

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