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Digital Technology in Clinical Trials Conference

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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

Lauren Oliva, PharmD, RPh

  • Director, Global Regulatory Policy & Digital Health 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

Speaker

Katie Chowdhury, MS

  • Director, RA Digital & Medical Device Team, Emerging Technology & Combo Products
  • Abbvie, United States
M. Khair ElZarrad, PhD, MPH

Speaker

M. Khair ElZarrad, PhD, MPH

  • Director, Office of Medical Policy, CDER
  • FDA, United States
Lesley Maloney, PharmD

Speaker

Lesley Maloney, PharmD

  • Global Regulatory Policy Lead - Digital Health and Integrated Solutions
  • Genentech, A Member of the Roche Group, United States
Ritu Kapur, PhD

Speaker

Ritu Kapur, PhD

  • Head of Clinical R&D | Head of Digital Biomarkers
  • Verily Life Sciences, United States

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