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A Comprehensive Review of Regulatory Procedures for New Drug Applications in the US

This course is designed for persons with a novice to intermediate experience in Regulatory Affairs, who need knowledge of the US NDA regulatory processes.


Overview

As drug development becomes a global process, have you had questions about US Regulatory requirements? Do you wonder why your US colleagues ask for certain documents or information?
This course will focus on drug and biologic products; the regulatory process for devices or multisourced (generic) products will not be addressed.

 

What you will learn

  • Regulation of drugs and biologics: The basics
  • Overview of the FDA
  • Regulatory requirements for drug development and approval
  • Interactions with FDA
  • Submitting the NDA in CTD format – What’s unique to FDA
  • Post-approval regulatory requirements for NDAs
  • US regulatory requirements for advertising and labelling
  • Regulatory compliance and FDA Inspections: What to expect after submitting the NDA

Who should attend?

This course is specifically designed for persons with a background in pre-clinical research (e.g., pharmacology, toxicology, and drug metabolism), clinical research, quality assurance or academia, with novice to intermediate experience in Regulatory Affairs, who need knowledge of the US regulatory processes.
This course will also enhance understanding and be beneficial to persons who work in clinical research, data management, biostatistics, basic research, project management and marketing, etc.
DIA also welcomes attendance by regulatory agency staff members.

 

Learning objectives

At the conclusion of this course, participants will be able to:

  • Define the key principles and processes used by the US Food and Drug Administration (FDA) in regulatory submission and approval
  • Define official regulatory policies and other issues pertinent to a successful US regulatory strategy
  • Describe key differences between US and EU regulatory requirements
  • Describe the requirements for marketing applications for drugs and biologics, New Drug Application (NDA) and Biologics License Application (BLA) and document preparation
  • Recognise FDA oversight and processes during the post-approval phase
  • Interact appropriately with the FDA during all phases of drug development

Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.


Plan Your Team's Professional Development

Why not take advantage and train your whole department (or even across different departments!) and benefit from increased:

  • Focus
  • Flexibility
  • Convenience
  • Cost Effectiveness

For more information please contact EMEA@DIAglobal.org

Contact us



Registration Questions

Send Email
+41 61 225 51 51


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+41 61 225 51 55