Regulatory Affairs: The IND, NDA, and Post-Marketing On-Demand Training
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Keyword(s)
Regulatory, IND, NDA, Post-marketing, FDA, meetings, strategy, submission, prescription drugs, well-characterized biologic products
Learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, post-marketing requirements, and the importance of regulatory strategy. This comprehensive fundamentals on-demand course will focus on FDA regulations and expectations for the content, submission and review of INDs and NDAs, post-marketing requirements, and the importance of regulatory strategy throughout the product lifecycle. This high-level but comprehensive course employs a blend of real-world examples, interactive lectures, on-demand workshops, and pre-course modules. This basic to intermediate online training course focuses on prescription drugs and well-characterized biological products.Register Here!
Description
At the conclusion of this activity, participants should be able to:
- Evaluate 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