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Monday, June 24 • 2:15pm - 3:15pm
#148: Hot Topics in Digital Health: How is FDA’s Approach Evolving, and What Do Industry and Patients Need to Know?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-553-L04-P; CME 1.00; IACET 1.00; RN 1.00

FDA’s approach to digital health is evolving. The agency has issued a series of guidances and other policies in recent years on digital health technologies <b><b This panel will explore how these policies may impact patients and innovators. As part of this discussion, panelists will also consider how digital health policies are shifting and where additional work could be done to facilitate innovation. We’ll explore FDA’s thoughts on how DH could help to incorporate the patient voice, generate real world evidence, and improve postmarket surveillance. Join us for an interactive discussion among a diverse set of stakeholders.

Learning Objectives

Describe FDA’s current thinking on digital health; Assess the potential impact of digital technologies on FDA priorities such as patient voice, real world evidence generation, post-market safety; Assess future opportunities for digital health to impact medical product development.

avatar for Nancy Myers

Nancy Myers

President and Founder, Catalyst Healthcare Consulting, Inc
Nancy Bradish Myers, JD is President/Founder of Catalyst Healthcare Consulting, a boutique regulatory advisory firm that helps innovators navigate FDA and policy circles. She served as a senior advisor in FDA's Office of the Commissioner and held senior positions at PhRMA, BIO and... Read More →
avatar for Jacqueline Corrigan-Curay

Jacqueline Corrigan-Curay

Director, Office of Medical Policy, CDER, FDA
Jacqueline Corrigan-Curay, J.D., M.D., serves as Director of the Office of Medical Policy (OMP) in the Center for Drug Evaluation and Research, FDA. OMP is comprised of the Office of Prescription Drug Promotion (OPDP) and the Office of Medical Policy Initiatives (OMPI). Dr. Corrigan-Curay... Read More →
avatar for Catherine Kopil

Catherine Kopil

Director, Research Partnerships, The Michael J. Fox Foundation for Parkinson's Research
As Director of Research Partnerships at The Michael J. Fox Foundation (MJFF), Katie focuses on building the Foundation’s capacity as an unprecedented stakeholder in Parkinson’s drug development — a nimble, patient-focused problem-solver whose efforts are demonstrably accelerating... Read More →

Yarmela Pavlovic

Partner, Global Regulatory, Hogan Lovells

Monday June 24, 2019 2:15pm - 3:15pm
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Credit Type ACPE, CME, IACET, RN
  • Tags Forum