Regulatory Affairs: The IND, NDA, and Postmarketing

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 and interactive lectures, workshops, and online precourse modules. This basic to intermediate level training course focuses on prescription drugs and well-characterized biological products. The requirements specific to generic drugs, 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.”

-Previous Participant

• 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 for Prescription Drug Labeling and Advertising
• Postmarketing Requirements
  

• 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
  

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 in the Common Technical Document (CTD) Format
• 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 mechanisms to facilitate and expedite new drug development
• 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