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Partnering with Regulatory Authorities to Unlock the Value in Digital Health Products
Session Chair(s)
Rebecca Joy James, MBA, RAC
Director - Advisory
KPMG, LLC, United States
Discussion of partnering with regulators to get novel digital health products through the approval processes. Learn insights from industry and regulators for creative, strategic, and flexible thinking on regulation of novel technologies.
Learning Objective : Discuss the challenges of introducing novel digital technologies to FDA; Describe tactics to build better partnerships with regulators.
Speaker(s)
Panelist
Anindita Saha
FDA, United States
Associate Director Strategic Initiatives, Digital Health Center of Excellence
Panelist
James Wabby, MHS
AbbVie, United States
Global Head, Regulatory Affairs, Emerging Technologies and Combination Products
Panelist
Adam Cargill, MS
MediView XR, Inc., United States
Director, QARACA
Panelist
Wes Gerbig, PhD, MS
Eli Lilly and Company, United States
Director, Global Regulatory Affairs, Drug Delivery and Digital Health
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