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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
Rob Berlin, JD, MPH
GlaxoSmithKline, United States
Head, US Regulatory Policy
Speaker
Alan Yeomans, MSc
Viedoc, Sweden
Regulatory Affairs Manager
Speaker
Anindita Saha
FDA, United States
Associate Director Strategic Initiatives, Digital Health Center of Excellence
Speaker
Imein Bousnina, PharmD, MSc
Genentech, A Member of the Roche Group, United States
Program Director, US Regulatory Policy, Product Development Regulatory
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