Investigational New Drug (IND) & Investigational Device Exemptions (IDE) Applications Preparation and Submission, and Conducting FDA Meetings: 2-Day In-Person Seminar

By: Marina Malikova,Ph.D, MSci, MA, CCRA, RAC, Executive Director, Boston University School of Medicine
Location 1:- San Francisco, CA | Thursday, August 23, 2018 | Friday, August 24, 2018

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Course Description:

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

Course Outline

Day One (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 Two (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

Meet Your Instructor

Marina Malikova
Marina Malikova
Executive Director, Boston University School of Medicine

Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.

Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She also holds a Master’s Degree in Clinical Investigation and Project Management Certification from Boston University.

In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, safety monitoring, strategic planning, and macro-management of research programs. She provides guidance and oversight to the Project Managers, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), and laboratory staff. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance.

Location :
San Francisco, CA
(Venue to be announced shortly)

August 23-24, 2018
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$1,499

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