Menu
×
Don't Miss Out!
Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA!
Digital Technology in Clinical Trials Conference
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
- 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)
Speaker
Katie Chowdhury, MS
- Director, RA Digital & Medical Device Team, Emerging Technology & Combo Products
- Abbvie, United States
Speaker
M. Khair ElZarrad, PhD, MPH
- Director, Office of Medical Policy, CDER
- FDA, United States
Speaker
Lesley Maloney, PharmD
- Global Regulatory Policy Lead - Digital Health and Integrated Solutions
- Genentech, A Member of the Roche Group, United States
Speaker
Ritu Kapur, PhD
- Head of Clinical R&D | Head of Digital Biomarkers
- Verily Life Sciences, United States
Contact us
Registration Questions?
Preconference Short Course
Digital Health - From Concept to Implementation
Discover DIA’s Live In-Person Events
Digital Technology in Clinical Trials Conference Resource Kit