2020 Virtual Research Compliance Conference

Research Stepchildren: Humanitarian Use Devices and Expanded Access to Investigational Medical Products

  • Research Stepchildren: Humanitarian Use Devices and Expanded Access to Investigational Medical Products

    Deneice Kramer, Compliance Manager, Essentia Health. Cathy Murray, Compliance Specialist, Essentia Health. Kim Wold, Compliance Specialist, Essentia Health.

    June 3, 2020

    • Review related laws and regulations which help define HUDs and Expanded Access

    • Describe IRB and institutional challenges when reviewing and monitoring HUDs and Expanded Access projects

    • Essentia Health’s approach, lessons learned and yet to be learned

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The Society of Corporate Compliance and Ethics (SCCE) is a non-profit, member-based professional association. SCCE supports our members' work with education, news, and discussion forums. We are a community of leaders, defining and shaping the corporate compliance environment across a wide range of industries and geographic regions. In developing and maintaining effective ethics and compliance programs, our members strengthen and protect their companies.

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About HCCA

The Health Care Compliance Association (HCCA), is a 501(c)6 non-profit, member-based professional association. HCCA was established in 1996 and is headquartered in Minneapolis, MN. We provide training, certification, and other resources to over 10,000 members. Our members include compliance officers and staff from a wide range of organizations, including hospitals, research facilities, clinics and technology service providers.

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