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03-Oct-2019 - 04-Oct-2019

Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings

  • Location:
    • Venue to be announced shortly
    • Philadelphia
    • Pennsylvania
    • 19019
    • United States
  • View on a map

Learning Objectives:

  • Identify the required regulations and guidance documents for drug and device submissions
  • Use regulations and guidance documents to outline and construct drug and device submissions
  • Formulate a working knowledge of regulatory submissions, publishing, and style guides
  • Create checklists that encompass timelines and sections needed from contributors

Areas Covered:

  • Contents of IND and IDE
  • Regulatory requirements for IND and IDE application process
  • Submissions to IND or IDE to the FDA
  • Establishing communications with FDA
  • Type of FDA meetings
  • Amendments to IND and IDE applications
  • Progress reports for IND and IDE

Who will Benefit:

  • Project Managers
  • Clinical Research Associates
  • Data Managers
  • Project Team Leaders with limited direct regulatory experience
  • Grant Administrators
  • Regulatory Associates
  • Quality Assurance specialists
  • Manufacturing, Clinical, and Pre-Clinical Personnel which will be contributing to the IND/IDE or want to learn more about IND/IDE applications process