Overview

Learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy. This comprehensive course employs a blend of real-world examples, interactive lectures, workshops, and online pre-course modules. This basic to intermediate level training course focuses on prescription drugs and well-characterized biological products. The requirements specific to generic drugs, biosimilars, devices, and OTC monograph products are not covered in detail.

“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

Couldn't attend this course? Join us in Bethesda in April or Boston in August or Philadelphia in October!

What you will learn

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

Preparation
Content
Maintenance and updates
Strategy

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?

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:

Explain the importance of incorporating regulatory strategy into the drug development plan
Recognize content and format requirements for INDs/NDAs in the Common Technical Document (CTD) Format
Communicate the requirements for submitting INDs/NDAs and amendments and supplements
Describe the FDA review processes for evaluating INDs/NDAs
Define NDA post-approval responsibilities and requirements
Identify regulatory mechanisms to facilitate and expedite new drug development
State how to report adverse events in accordance with current FDA regulations
Apply formal meeting principles and practices when interacting with the FDA
Outline the regulatory requirements for prescription drug labeling and advertising

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