Regulatory Affairs: The IND, NDA, and Post-Marketing Training Course

Keyword(s) Regulatory, IND, NDA, Post-marketing

Learn about 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, workshops, and online pre-course modules. This basic to intermediate online training course focuses on prescription drugs and well-characterized biological products. The requirements specific to generic drugs, traditional biologics, biosimilars, devices, and OTC monograph products are not covered in detail.

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Tag(s) eLearning, Regulatory Affairs, Pharmaceutics

Description

What You Will Learn

Fundamentals of the Investigational New Drug (IND) and New Drug Application (NDA) Processes

Preparation
Content
FDA review of applications
Amendments and maintenance
Regulatory intelligence and strategy

What to expect at meetings and in other interactions with FDA
Regulatory Requirements for Prescription Drug Labeling and Advertising
Post-Marketing Requirements