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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
Associate Director Strategic Initiatives, Digital Health Center of Excellence, C, FDA, United States
Panelist
James Wabby, MHS
VP, Head of Regulatory Strategy, Emerging Technologies and Combination Products, AbbVie, United States
Panelist
Adam Cargill, MS
Director, QARACA, MediView XR, Inc., United States
Panelist
Wes Gerbig, PhD, MS
Director, Global Regulatory Affairs, Drug Delivery and Digital Health, Eli Lilly and Company, United States
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