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

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 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 training course focuses on prescription drugs (primarily small molecules) and well-characterized biological products. The requirements specific to generic drugs, traditional biologics, biosimilars, devices, and OTC monograph products are not covered in detail. However, many of the regulations, principles, and processes described in this course will apply to these types of products.

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Tag(s) Regulatory, Regulatory Affairs, Submissions

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Description

What You Will Learn

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

Preparation
Content
FDA review of applications
Amendments and maintenance
Regulatory strategy

What to expect at meetings and in other interactions with FDA
Regulatory requirements for prescription drug labeling and promotion
Adverse event reporting and risk management in the pre- and post-marketing settings
Post-marketing requirements
Sources of regulatory intelligence information