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Hotel Pullman Brussels Midi

Nov 14, 2016 7:30 AM - Nov 16, 2016 5:30 PM

Place Victor Horta 1, 1060 Brussels, Belgium

US Regulatory Affairs: A Comprehensive Review of Regulatory Procedures for INDs and NDAs in the US

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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 is specifically designed for persons with a background in pre-clinical research (e.g., pharmacology, toxicology, 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 Europe also welcomes attendance by regulatory agency staff members. Participants need to have some knowledge of the ICH and in particular the Common Technical Document (CTD). Participants will gain a better understanding of the US regulation of investigational new drugs (INDs) and biologics, of the basics of submission of applications seeing marketing approval for a product (NDA & BLA) and post-marketing regulatory requirements in the US.

What you will learn

  • Regulation of drugs and biologics: The basics
  • Overview of the FDA
  • Regulatory requirements for drug development and approval
  • The IND - A general introduction
  • The IND - In detail
  • IND Amendments and maintenance
  • Procedures for reporting Adverse Events (AEs) that occur during clinical investigations
  • Submitting the NDA in CTD format – What’s unique to FDA
  • Post-approval regulatory requirements for NDAs
  • Interactions with FDA
  • US regulatory requirements for advertising and labelling
  • Regulatory compliance and FDA Inspections: What to expect after submitting the NDA
  • Navigating the FDA on the internet

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
  • Understand the regulatory requirements for prescription drug labelling and advertising/promotion and differences with EU requirements

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

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