Overview

Regulatory Affairs: The IND, NDA, and Postmarketing

Fundamentals of IND/NDA submissions and Postmarketing Regulatory Requirements

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 lectures, workshops and online precourse modules. The course focuses on prescription drugs and well characterized biological products and not the regulatory process for devices, generic products, OTC products or traditional biologics.
Course Level: Beginner

What you will learn

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

Preparation
Content
Strategy

What to expect at meetings and other interactions with FDA
Regulatory Requirements of Prescription Drug Labeling and Advertising
Postmarketing 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 IND/NDA in the Common Technical Document (CTD) Format
Communicate the requirements for submitting INDs/NDAs and amendments
Describe the FDA review processes for evaluating INDs/NDAs
Define NDA post-approval responsibilities and requirements
Identify regulatory mechanisms to facilitate development of new therapies
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

Digital Learning Catalog

Download

Have an account?