Regulatory Affairs: The IND, NDA, and Post-Marketing On-Demand Training
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Keyword(s)
Online learning; On Demand Training; Safety & Pharmacovigilance; FDA; EMA; Professional Development; Communication; Risk
Learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy. This comprehensive course employs a blend of recorded lectures, real-world examples, scenario-based activities, and self-paced online modules. This basic to intermediate level training course focuses on prescription drugs and well-characterized biological products.Register Here!
Credit Information
ACPE = 19
IACET = 1.9
IACET = 1.9
Description
Learning Objectives
At the conclusion of this activity, participants should be able to:
- Recognize the importance of incorporating regulatory strategy into the drug development plan
- Identify content and format requirements for INDs and NDAs
- Outline the requirements for submitting INDs, NDAs, amendments, and NDA supplements
- Explain the FDA review processes for evaluating INDs and NDAs
- Define NDA post-approval responsibilities and requirements
- Identify regulatory programs and mechanisms that can facilitate and expedite new drug development
- Determine how to report adverse events in accordance with FDA pre-marketing and post-marketing regulations
- Apply sound meeting practices and productive dialogue principles when interacting with the FDA
- Outline the regulatory requirements for prescription drug labeling and promotion
- Identify resources for regulatory intelligence