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


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Submissions to a regulatory agency involve more than just writing of applications. They also encompass strategy, editing, publishing and systematic tracking of key information. Through formal lectures, case studies, and hands-on exercises, new and experienced regulatory professionals will learn how to interpret regulations and guidance documents to produce submissions that comply with the requirements and are clear to the reviewers.

In this practical course, which is designed to help participants to acquire the knowledge and insight needed to understand and begin to construct core U.S. drug and biologics submissions, including Investigational New Drug (IND), and Investigational Device Exemptions (IDE) applications. Participants also will gain experience with tools that help manage timelines and sections needed from contributors.

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
DAY 01(8:30 AM - 4:30 PM)
  • 8:30 AM - 8:59 AM: Registration. Meet & Greet.
  • 9:00 AM - 11:00 AM: 
    FDA Division Information. Overview of Submissions Process and Assembling Application: creating the Table of Contents, timing of submission/timelines, contributions from other departments, editing, style guides, templates, supportive documents, QA for the submission.
  • 11:00 AM - 12:00 Noon: 
    Overview of Investigational Drug Application (IND) format and contents.
  • 12:00 Noon - 1:00 PM: Lunch.
  • 1:00 PM - 2:30 PM: 
    Preparation for IND Submission. Routine IND Submissions: Assembling clinical, non-Clinical, CMC, etc. data for FDA drug applications.
    • Tracking the Submissions: Creating the index history an issues log.
  • 2:30 PM - 3:00 PM: Refreshments Break.
  • 3:00 PM - 4:30 PM: Preparation for meetings with FDA.
    • Types of FDA Meetings: Type A, B and C;
    • Pre-IND, Phase I, Phase II, End of Phase II, requesting the meeting, preparing the meeting package, meeting minutes.
DAY 02(8:30 AM - 4:30 PM)
  • 8:30 AM - 8:59 AM: Registration, Meet & Greet.
  • 9:00 AM - 11:00 AM:
    • IND Maintenance: Annual Reports, Safety Reports and Investigator Brochure updates, protocol and informational amendments, Investigator change notifications.
    • Special situations for IND submissions: Fast track, orphan drug designation, special protocol assessment.
  • 11:00 AM - 12:00 Noon: 
    Overview of device classes, significant and non-significant risk determinations.
  • 12:00 Noon - 1:00 PM: Lunch.
  • 1:00 PM - 2:00 PM:
    • Investigational Device Exemption (IDE) content and application process, regulatory requirements and best practices.
    • Strategies for new device application submissions with FDA depending on the class of the device.
  • 2:00 PM - 2:30 PM: 
    IDE maintenance: supplements, amendments, safety and annual reports. Additional types of device studies: Extended access programs and Humanitarian Device Exemption (HUD).
  • 2:30 PM – 2:45 PM: Refreshments Break.
  • 2:45 PM – 3:45 PM:
    • Group work on the case study.
    • Case Study: “Investigational New Drug Application Preparation”.
  • 3:45 PM - 4:30 PM: Discussion of the Case study and Closing remarks
Seminar (Price/Register)
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

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