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Oct 13, 2022 9:45 AM - Oct 14, 2022 4:30 PM

(US Eastern Standard Time)

Digital Technology in Clinical Trials Conference

Digital Technology in Clinical Trials Conference is now fully virtual. Join us from the comfort of your own space!

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

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


Katie  Chowdhury, MS


Katie Chowdhury, MS

Abbvie, United States

Director, RA Digital & Medical Device Team, Emerging Technology & Combo Products

M. Khair  ElZarrad, PhD, MPH


M. Khair ElZarrad, PhD, MPH

FDA, United States

Director, Office of Medical Policy, CDER

Lesley  Maloney, PharmD


Lesley Maloney, PharmD

Genentech, A Member of the Roche Group, United States

Global Regulatory Policy Lead - Digital Health and Integrated Solutions

Ritu  Kapur, PhD


Ritu Kapur, PhD

Verily Life Sciences, United States

Head of Clinical R&D | Head of Digital Biomarkers

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