MICHR IND/IDE Investigator Assistance Program (MIAP)

2013 Team Award, Medical School Administration, "Award for Integration, Collaboration, and Teamwork"

** Please note, effective 10/1/2013, MIAP has implemented a U of M approved recharge (fee-for-service) rate structure for our services. Please contact Kevin Weatherwax at 998-6275 or kweath@med.umich.edu for the rate structure to assist with your budgetary planning **

Overview

The MICHR IND / IDE Investigator Assistance Program (MIAP) was established to provide comprehensive regulatory support, guidance, and education services to faculty investigators involved in US Food and Drug Administration (FDA) regulated clinical research at the University of Michigan.

MIAP's primary focus is regulatory assistance to sponsor-investigators of a drugs, biologics, or medical devices. Our efforts help ensure clinical research excellence and regulatory compliance as set forth by the University of Michigan Health System and the FDA. We are certified regulatory professionals with varied biomedical backgrounds in both academia and industry. Combined, our experiences include over 75 years in clinical and preclinical research and over 45 years in regulatory affairs. Let us leverage that knowledge to help you attain your goals.

MIAP offers regulatory assistance to clinical investigators planning to utilize either a drug or biological product classified by the FDA as an Investigational New Drug (IND) per 21 CFR Part 312 or a medical device subject to Investigational Device Exemption (IDE) regulations per 21 CFR Part 812. Regulatory assistance includes:

  • IND and IDE Regulatory Education Services
    • Investigator responsibilities per FDA regulations
    • IND (21 CFR Part 312) regulation overview training
    • IDE (21 CFR Part 812) regulation overview training
    • Good Clinical Practice (GCP) training and coaching
    • FDA Quality System Regulations and Good Manufacturing Practice (GMP) training
    • Good Laboratory Practice (GLP) training and coaching
    • Adverse Event Reporting requirements for investigator-initiated research
    • IND and IDE application process overview
    • IND and IDE annual FDA reporting requirements training
  • IND and IDE Regulatory Assistance Services
    MIAP provides comprehensive regulatory guidance and assistance to faculty sponsor investigators seeking to conduct clinical investigations that require advance US FDA approval. Regulatory assistance includes:
    • Pre-study preparation assistance
      • IND and IDE applicability assessments
      • FDA Meeting Preparation and Assistance (Pre-IND, Pre-IDE)
        • IND and IDE submission assistance
          • Protocol development assistance
          • Literature search assistance
          • IND and IDE preparation
          • FDA contact and correspondence assistance
      • On-going study assistance
        • Safety and FDA vigilance reporting
        • IND and IDE FDA annual report preparation and submission
        • DSMB communications assistance
        • IND and IDE protocol amendment preparation assistance
        • IND Amendments and Life Cycle Maintenance assistance
        • IDE Supplements and Life Cycle Maintenance assistance
      • Post-study assistance
        • IND and IDE close-out support

    Contact

    MIAP TEAM
    Shared group e-mail for documents:

    MICHRMIAP@med.umich.edu

     

    Kevin Weatherwax, CCRC, CCRA

    Manager

    kweath@med.umich.edu
    734.998.6275

     

    Jeanne Wright, RN, BSN, MT, CCRP, CIM, RAC

    Regulatory Project Manager, Lead

    jeanburn@med.umich.edu
    734.998.7598 

     

    E Mitchell Seymour, PhD, RAC
    Research Investigator, Regulatory Project Manager
    seymoure@med.umich.edu
    734.998.6585

    Bill Reisdorph, MS, CQA, RAC

    Regulatory Project Manager
    reisdorp@med.umich.edu
    734.998.8427

    Mona Moore, MS, RAC
    Regulatory Project Manager
    monamoor@med.umich.edu
    734.998.7818

    For more information on MICHR please contact us at 734.998.7474 or e-mail UM-michr@umich.edu

    Feedback on this page? E-mail Mitchell Seymour

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