Regulatory Affairs: The IND, NDA, and Post-Marketing On-Demand Training
Overview
Complete this On-Demand 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 recorded lectures, real-world examples, scenario-based activities, and self-paced online modules. This basic to intermediate level training course focuses on prescription drugs and well-characterized biological products.
This on-demand training course takes an average of 19 hours to complete. Learners have access to the course for one year from the date of purchase.
This course will also be offered as a nine-part live-virtual training August 21-25, 2023. Register Now!
“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
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
- 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 programs and mechanisms that can facilitate and expedite new drug development
- State how to report adverse events in accordance with current 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 advertising
