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Session 9 Regulatory Sprint: Can We Develop an Agile Regulatory Decision Matrix for Digital Measurement?
Session Chair(s)
Lauren Oliva, PHARMD, RPH
US Regulatory Policy Lead, Biogen, United States
Megan Doyle, JD, MPH
Associate Vice President, Assistant General Counsel - Diagnostics, Eli Lilly and Company, United States
Anindita Saha
Associate Director Strategic Initiatives, Digital Health Center of Excellence, C, FDA, United States
This interactive panel session will explore a fictional case study of a digital health technology (DHT) used as a measurement tool in a drug clinical trial. An expert panel will engage in a dialogue, including audience polls and Q&A, about regulatory considerations for selection of the most appropriate endpoint, how to measure the endpoint, and verification and validation as it applies to the hypothetical case study.
Learning Objective : At the conclusion of this session, participants should be able to:
- Explore evidence criteria to be addressed for digital health technologies (DHTs) in clinical trials through a case example
- Evaluate regulatory questions based on drug program goals and DHT medical device status and intended use
Speaker(s)
Anindita Saha
Associate Director Strategic Initiatives, Digital Health Center of Excellence, C, FDA, United States
Speaker
Jeffrey Nahum Siegel, DrMed, MD
Director, Office of Drug Evaluation Sciences, OND, CDER, FDA, United States
Speaker
Elizabeth Kunkoski, MS
Health Science Policy Analyst, OMP, CDER, FDA, United States
Speaker
Matthew Diamond, MD, PHD
Chief Medical Officer, Digital Health Center of Excellence, CDRH, FDA, United States
Speaker
Samantha Roberts, PHD
Senior Director, Regulatory Intelligence, AstraZeneca, United States
Speaker
Simon Bennett, MS
Director, EU Regulatory Policy, Biogen, United Kingdom
Speaker
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