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Session 5: Innovating in the Gray Space: How do we Successfully Advance Digital Health Tools as the Regulatory Science Evolves?
Session Chair(s)
Lauren Oliva, PharmD, RPh
US Lead, Global Regulatory Policy
Biogen, United States
“Not if, but how” is the reality for drug developers adopting digital technologies in global product strategies. While regional regulatory expectations are taking shape with formal guidance and early precedents, we are beginning to experience the early stages of global divergence in terminology, standards, and regulatory practices. This panel session will discuss how to move forward despite conflicting regulatory feedback and how we can right the ship of global regulatory harmonization for digital health tools.
Learning Objective : At the conclusion of this session, participants should be able to:
- Explain the main gaps in current regulatory expectations in the United States (US) and European Union (EU) as of today
- Evaluate different resources that can supplement existing regulatory guidance and help to inform globally harmonized guidelines
- Propose topics and mechanisms to drive regulatory predictability and successful adoption of digital tools in global clinical trials
Speaker(s)
Speaker
Katie Chowdhury, MS
Abbvie, United States
Director, RA Digital & Medical Device Team, Emerging Technology & Combo Products
Speaker
M. Khair ElZarrad, PhD, MPH
FDA, United States
Director, Office of Medical Policy, CDER
Speaker
Lesley Maloney, PharmD
Genentech, A Member of the Roche Group, United States
Global Regulatory Policy Lead - Digital Health and Integrated Solutions
Speaker
Ritu Kapur, PhD
Verily Life Sciences, United States
Head of Clinical R&D | Head of Digital Biomarkers
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