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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

Is Your App a Drug, a Device, or Something Else Entirely?

Session Chair(s)

Ernest S. Voyard, JD

Ernest S. Voyard, JD

Associate Director, Global Regulatory Policy and Intelligence

Janssen Research & Development, LLC, United States

This forum will present and examine FDA’s regulation of “apps” and discuss what is required to bring these types of digital health technologies to market. A panel of experts will discuss their experience working with the FDA in this evolving area.

Learning Objective : Discuss FDA’s current landscape regarding the regulation of mobile digital health solutions (or “apps); Describe best practices when working with the agency to bring such solutions to market; Explain how to differentiate between those products that may be considered a device, a drug, or a “digital therapeutic”.

Speaker(s)

Kristina  Lauritsen, PhD

FDA Perspective

Kristina Lauritsen, PhD

FDA, United States

Combination Products Regulatory Policy Advisor, OEP, CDER

Yuri  Maricich, MD, MBA

Industry Perspective

Yuri Maricich, MD, MBA

Pear Therapeutics, United States

Chief Medical Officer and Head of Development

Vernessa  Pollard, JD

Industry Perspective

Vernessa Pollard, JD

McDermott Will & Emery LLP, United States

Partner, Chair FDA Pratice

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