Overview

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 drug and well characterized biological products and not the regulatory process for devices, generic products, or traditional biologics.

Course Level: Beginner

Feedback from Our Participant(s)

"This is the first DIA course I have taken and by far, the best I've ever taken. The instructors have a wealth of knowledge and experience with Regulatory Affairs and the FDA. A great class overall."

"This Regulatory class was the best course I've ever taken. A huge thanks to all for making it a valuable and wonderful experience!"

"This was a great beginner course in regulatory affairs. I learned a lot and was able to meet people from different companies."

"A very throughtout course. Recommended also for people without a pharmaceutical background."

"Course exceeded my expectations. It was informative, intersting, interactive and relevant to my work. The instructors were very good, and provided many examples that brought the learning materials to life."

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
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
State the IND/NDA reporting requirements and amendments
Describe the FDA review processes for evaluating IND/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

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