Regulatory Affairs: The IND, NDA, and Post-Marketing
Attend this virtual training course to 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, traditional 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.”
Can't attend this course? Join us Virtually in October!
What you will learn
- Fundamentals of the Investigational New Drug (IND) and New Drug Application (NDA) Processes
- Maintenance and updates
- 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?
At the conclusion of this activity, participants should be able to:
- Define the importance of incorporating regulatory strategy into the drug development plan
- Recognize content and format requirements for INDs/NDAs
- Cite the requirements for submitting INDs/NDAs and amendments and supplements
- Identify the FDA review processes for evaluating INDs/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 current FDA pre-marketing and post-marketing regulations
- Define sound meeting practices and productive dialogue principles when interacting with the FDA
- Outline the regulatory requirements for prescription drug labeling and advertising