Basics of the NDA

Agenda

Day 1 May 20, 2014

12:00 PM — 1:30 PM

Part 1: The NDA in CTD Format

Day 2 May 21, 2014

12:00 PM — 1:45 PM

Part 2: The NDA in CTD Format: Modules 1- 5

Day 3 May 22, 2014

12:00 PM — 1:45 PM

Part 3: The NDA in CTD Format: Modules 1- 5 (cont’d)

Day 4 May 28, 2014

12:00 PM — 1:45 PM

Part 4: The NDA in CTD Format: Submission

Day 5 May 29, 2014

12:00 PM — 1:30 PM

Part 5: Post-NDA Approval Regulatory Requirements

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