Overview

Attend this virtual training course to 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. View the detailed agenda. The requirements specific to generic drugs, traditional biosimilars, devices, and OTC monograph products are not covered in detail.

Can't attend this live virtual offering? Register for the on demand version of this course.

“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

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 of prescription drug labeling and promotion
Post-marketing requirements

Who should attend?

Regulatory affairs professionals new to the IND/NDA processes

Clinical research and development professionals

Biostatisticians

Basic researchers

Quality and manufacturing professionals

Medical writers

Business professionals

Project managers

Learning objectives

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

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