Regulatory Affairs: The IND, NDA, and Post-Marketing

A basic-to-intermediate training course from DIA on US FDA requirements across the product lifecycle: IND applications and maintenance, safety reporting in clinical trials, NDA planning, content, submission and review, expedited pathways, labelling, post-approval obligations and promotion. Combines real-world examples, interactive lectures, team workshops and an online pre-course module.

What you’ll learn:

• ND and NDA preparation, content and FDA review
• Regulatory strategy for INDs, NDAs and post-marketing submissions
• Meetings and interactions with FDA
• Labelling and promotion requirements
• Adverse event reporting and risk management
• Post-marketing requirements
• Sources of regulatory intelligence

Details:
Type: Course
Format: Live virtual; on-demand version available
Language: English
Start: Last live edition: 17–21 Aug 2026 (already held)
Price: $3,765.00
Provider: DIA – Drug Information Association
Instructor(s): DIA faculty
Contact: Basel@DIAglobal.org