Overview

This course offers a comprehensive overview of the FDA regulatory landscape, essential for pharmaceutical industry professionals and informative for others interested in the development of drugs and biological products in the US. Participants will explore the full lifecycle of regulatory submissions, including IND applications and maintenance; safety reporting in clinical trials; NDA planning, content development, submission, and FDA review. The curriculum covers special regulatory considerations for expedited development, development of product labeling, post-approval requirements, and standards for promotional activities.

Learners will gain practical knowledge to plan and prepare IND and NDA submissions with insight into various regulatory approaches, pathways, and opportunities for FDA interactions. This basic-to-intermediate course blends recorded lectures, real-world examples, scenario-based activities, and self-paced online modules, an online pre-course module, downloadable resources, and a Hot Topics session that will discuss recent events. This course focuses on prescription drugs and well-characterized biological products. The requirements specific to generic drugs, complex biologics, biosimilars, medical devices, and OTC monograph products are not covered in detail. However, the principles, as well as many of the regulations and processes, described in this course will also apply to these types of products.

This on-demand training course takes an average of 24 hours to complete. Learners have access to the course for one year from the date of purchase.

“The course is replete with information that has swirled around me since starting work in RA but that had remained elusive due to the narrow nature of my day-to-day. The course provided structure for this swirling information, which gave me a clear picture of how the pieces fit together. I'd definitely recommend it to anybody who has worked in regulatory affairs for a few years and/or has experience in only one area of RA but desires to understand the whole picture.”

-Previous Participant

What you will learn

Featured Topics:
- Fundamentals of the Investigational New Drug (IND) and New Drug Application (NDA) processes including:
- What to expect at meetings and in other interactions with FDA
- Regulatory requirements of prescription drug labeling and advertising
- Post-marketing requirements

Who should attend?

This course is designed for professionals involved in:

Learning objectives

At the conclusion of this course, participants should be able to:
- Distinguish between laws, regulations, and guidances for drug and biologics
- Recognize the phases of drug and biologics development
- Identify the role of the regulatory professional during each of the product development stages
- Recognize the importance of incorporating regulatory strategy into the product development plan
- Identify regulatory programs and mechanisms that can facilitate and expedite new drug development and approval
- Identify content and format requirements for INDs and NDAs
- Outline the requirements for submitting INDs and IND amendments, and NDAs and NDA supplements
- Explain the FDA review processes for evaluating INDs and NDAs
- Define NDA post-approval responsibilities and requirements
- 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

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Regulatory Affairs: The IND, NDA, and Post-Marketing (On-Demand)

Overview

What you will learn

Who should attend?

Learning objectives

Be informed and stay engaged.