Menu Back toRegulatory Affairs: The IND, NDA, and Post-Marketing

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 and NDAs, and the importance of regulatory strategy.


Overview

Attend this virtual training course to 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 online training course focuses on prescription drugs and well-characterized biological products. View the detailed agenda. The requirements specific to generic drugs, traditional biosimilars, devices, and OTC monograph products are not covered in detail.

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

 


“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
    • FDA review of applications
    • Amendments and maintenance
    • Regulatory intelligence and strategy
  • What to expect at meetings and in other interactions with FDA
  • Regulatory requirements of prescription drug labeling and promotion
  • 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:

    • Evaluate the importance of incorporating regulatory strategy into the drug development plan
    • 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
    • Identify regulatory programs and mechanisms that can facilitate and expedite new drug development
    • 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

    Contact us

    Registration Questions?

    Send Email
    1.888.257.6457
    +1.215.442.6100