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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 Regulatory Policy Lead, 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)
Katie Chowdhury, MS
Director, RA Digital & Medical Device Team, Emerging Technology & Combo Products, Abbvie, United States
M. Khair ElZarrad, PHD, MPH
Vice President, Regulatory Policy, BridgeBio, United States
Lesley Maloney, PHARMD
Regulatory Policy Lead, Genentech, A Member of the Roche Group, United States
Ritu Kapur, PHD
Head of Clinical R&D | Head of Digital Biomarkers, Verily Life Sciences, United States
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