Course Agenda (Eastern Time)
10:00 AM – 12:00 PM: Lecture 1:
FDA's Latest Guidance Documents
Ground Rules for Writing, Formatting and Updating Content
Lecture 2: Module 1 of an eCTD
Module 2: Summaries in an NDA
12:00 PM – 12:45 PM: Lunch Break 12:45 PM – 2:30 PM: Lecture 3: Module 3: CMC Information Presentation
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Lecture 3 Continued..
Modules 4 and 5: Bulk Data from Non-Clinical and Clinical Studies
2:30 PM – 2:45 PM: Break 2:45 PM – 4:15 PM: Lecture 4: Putting the Whole Submission Together
Introduction to the FDA’s ESG
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