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Virtual

Aug 17, 2026 9:00 AM - Aug 21, 2026 3:30 PM

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

Attend this live, virtual training course to learn about FDA regulations and expectations for the content, submission and review of INDs and NDAs, and the importance of regulatory strategy.

Agenda

8:00 AM9:00 AM

Introduction to Regulation of Drugs and Biologics in the United States: Pre-Course Module

9:00 AM12:30 PM

Regulatory Affairs: Part 1: The IND – Investigational New Drug Application

12:15 PM1:00 PM

LUNCH BREAK

12:30 PM1:15 PM

LUNCH BREAK

1:15 PM5:15 PM

Regulatory Affairs: Part 2: IND Amendments

9:00 AM12:05 PM

Regulatory Affairs: Part 3: Special Topics and Adverse Event Reporting in Clinical Research

12:05 PM12:50 PM

LUNCH BREAK

12:50 PM5:15 PM

Regulatory Affairs: Part 4: Special Regulatory Programs and Quality Assurance in Drug Development

9:00 AM12:00 PM

Regulatory Affairs: Part 5: The NDA – New Drug Application

12:00 PM1:00 PM

LUNCH BREAK

12:45 PM5:30 PM

Regulatory Affairs: Part 6: Interactions with FDA

12:15 AM1:00 PM

LUNCH BREAK

9:00 AM12:15 PM

Regulatory Affairs: Part 7: Mock FDA Meeting

1:00 PM5:00 PM

Regulatory Affairs: Part 8: Post-NDA Submission and Approval

9:00 AM12:15 PM

Regulatory Affairs: Part 9: Labeling, Promotion, and Regulatory Intelligence

1:00 PM3:45 PM

Regulatory Affairs: Part 9: Labeling, Promotion, and Regulatory Intelligence (Continued)

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