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Online

Basics of the NDA Phase

Overview

This On Demand Training will take approximately 6 hours 45 minutes to complete.

This four-part online training series will discuss the aspects of New Drug Application (NDA) preparation. The course focuses on drug and well characterized biological products and not the regulatory process for devices, generic products, or traditional biologics.

Course Level: Beginner

Featured topics

  • Practical steps required to prepare an NDA
  • Review postapproval activities

Who should attend?

  • Regulatory affairs professionals new to the NDA process
  • Clinical research and development professionals
  • Biostatisticians
  • Basic researchers
  • Quality and manufacturing professionals
  • Medical writers
  • Business professionals
  • Project Managers

Learning objectives

At the completion of this activity, participants should be able to:

  • Recognize content and format requirements for NDA in the Common Technical Document (CTD) Format
  • Define postapproval requirements

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