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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 3: Regulations and Digital Health Technologies: Where Do We Stand and What Do We Do Next?

Session Chair(s)

Megan  Doyle, JD, MPH

Megan Doyle, JD, MPH

Associate Vice President, Assistant General Counsel - Diagnostics

Eli Lilly & Company, United States

Jules  Mitchel, PhD, MBA

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


Rob  Berlin, JD, MPH


Rob Berlin, JD, MPH

GlaxoSmithKline, United States

Head, US Regulatory Policy

Alan  Yeomans, MSc


Alan Yeomans, MSc

Viedoc, Sweden

Regulatory Affairs Manager

Anindita  Saha


Anindita Saha

FDA, United States

Associate Director Strategic Initiatives, Digital Health Center of Excellence

Imein  Bousnina, PharmD, MSc


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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