Overview

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 training course focuses on prescription drugs (primarily small molecules) and well-characterized biological products. The requirements specific to generic drugs, traditional biologics, biosimilars, devices, and OTC monograph products are not covered in detail. However, many of the regulations, principles, and processes described in this course will apply to these types of products.

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

What you will learn

- Fundamentals of the Investigational New Drug (IND) and New Drug Application (NDA)
- What to expect at meetings and in other interactions with FDA
- Regulatory requirements of prescription drug labeling and promotion
- Adverse event reporting and risk management in the pre- and post-marketing settings
- Post-marketing requirements
- Sources of regulatory intelligence information

Who should attend?

Regulatory affairs professionals new to IND/NDA activities
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:
- Recognize the importance of incorporating regulatory strategy into the drug development plan
- Identify regulatory programs and mechanisms that can facilitate and expedite new drug development
- 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
- 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