Course Agenda (Eastern Time)
Starts at 8.30 AM EST
Starts at 8.30 AM EST
9:00AM – 10:00AM: Lecture 1:
FDA's Latest Guidance Documents
Ground Rules for Writing, Formatting and Updating Content
10:00 – 10:15AM: Break 10.15 – 12 Noon: Lecture 2: Module 1 of an eCTD
Module 2: Summaries in an NDA
12:00 – 12:45PM: Lunch Break 12:45PM – 2:00PM: Lecture 3 and 4: Module 3: CMC Information Presentation
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Lecture 3 and 4: Continued..
Modules 4 and 5: Bulk Data from Non-Clinical and Clinical Studies
2:00PM – 2:15PM: Break 2:15PM – 3:15PM: Lecture 5: Putting the Whole Submission Together
Introduction to the FDA’s ESG
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