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Digital Technology in Clinical Trials Conference
Session 3: Regulations and Digital Health Technologies: Where Do We Stand and What Do We Do Next?
Session Chair(s)
Megan Doyle, JD, MPH
- Global Policy Lead, Digital Health, Diagnostics, Oncology
- Amgen, United States
Jules Mitchel, PhD, MBA
- President and CEO
- THI Pharma Services, United States
The session will review the impact of the FDA Guidance documents related to Digital Health Technologies (DHTs) as well as some global regulations, or lack thereof, that impact use of DHTs in clinical trials. The session will focus on what guidance is available, what is in the works, and what is still needed to advance the use of DHTs in clinical trials.
Learning Objective : At the conclusion of this session, participants should be able to:
- Discuss applicable guidance and regulations pertaining to use of DHTs in clinical trials
- Discuss what is working well and what is forthcoming or needed to advance the use of DHTs in clinical trials
Speaker(s)
Speaker
Robert Berlin, JD, MPH
- Head, US Regulatory Policy
- GlaxoSmithKline, United States
Speaker
Alan Yeomans, MSc
- Regulatory Affairs Manager
- Viedoc, Sweden
Speaker
Anindita Saha
- Assistant Director, Digital Health Center of Excellence, CDRH
- FDA, United States
Speaker
Imein Bousnina, PharmD, MSc
- Program Director, US Regulatory Policy, Product Development Regulatory
- Genentech, A Member of the Roche Group, United States
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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