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Basics of the NDA Phase


Overview

This basic online training course 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.

Featured topics

  • Issues involved in progressing from the IND to the NDA
  • Types of NDAs
  • Practical steps required to prepare an NDA
  • Review postapproval activities

Who should attend?

  • Regulatory affairs professionals new to the IND process
  • 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:

  • Recognize content and format requirements for NDA in the Common Technical Document (CTD) Format
  • Define NDA postapproval responsibilities and requirements
  • Understand the progression from the IND to the NDA

Contact us

Registration Questions?

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1.888.257.6457
+1.215.442.6100


Agenda and Event Logistics

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+1.215.442.6108