Regulatory Affairs: The IND, NDA, and Post-Marketing
- — Introduction to Regulation of Drugs and Biologics in the United States: Pre-Course Part One
- — Introduction to Regulation of Drugs and Biologics in the United States: Pre-Course Part Two
- — Regulatory Affairs: Part 1: The IND – Investigational New Drug
- — Lunch Break
- — Regulatory Affairs: Part 2: The IND Amendments
Learn how organizations structure their efforts and utilize their resources to improve the odds of successful development in this six module program.
This interactive virtual training course will demonstrate CMC sections of regulatory submissions, the FDA inspection process, and how to avoid or minimize 483s (noncompliance) using real-life scenarios.
Attend this virtual training course to learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy.