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.

This course offers a comprehensive overview of the FDA regulatory landscape essential for professionals in the pharmaceutical industry and informative for others who have an interest in the development of drugs and biological products in the US.

Participants will explore the full lifecycle of regulatory submissions, including IND applications and maintenance; safety reporting in clinical trials; NDA planning, content development, submission and FDA review.

The curriculum covers special regulatory considerations for expedited development, development of product labeling, post-approval requirements, and standards for promotional activities.