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
- — Virtual Reception
Complete this On-Demand Training Course to learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy.
The Canadian Annual Meeting now includes a track for Pharmacovigilence and Risk Management Strategies!
Register for this On-demand Training Course which will demonstrate CMC sections of regulatory submissions, the FDA inspection process, and how to avoid or minimize 483s (noncompliance) using real-life scenarios.