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Regulatory Procedures for New Drug Applications / Biologics License Applications in the US




London, United Kingdom


23 Oct 2018 - 24 Oct 2018

Reference No: D1802238 - DIA

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Key points about this Training Event

  • 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 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
Event Description


Course Outline:

This course will focus on marketing applications (NDA/BLA) for drug and biologic products; the regulatory process for medical devices or multisourced (generic) products will not be addressed

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

When & Where?

23 October 2018 - 24 October 2018

Holiday Inn London Kensington Forum 97 Cromwell Road
United Kingdom


Course fee for members of DIA: €1240
Course fee for delegates: €1395

Register for both "Comprehensive Review of Regulatory Procedures in the US" training courses and save up to EUR 765!


Applicant Requirements
  • 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
Reference No: D1802238 - DIA
DIA, a non-profit association, is the only global organization dedicated to bringing health care product development professionals together in a trusted, global, neutral environment to share insights and drive action in health care product development and life cycle management


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