Are you a digital health innovator? Are you building sensors, wearables, or other digital health tools to be used in clinical trials to capture information about how patients feel, function, or survive?
Join the FDA Center for Devices and Radiological Health (CDRH), the University of Maryland Center of Excellence in Regulatory Science and Innovation (CERSI), and the Johns Hopkins University CERSI for an immersive mini-bootcamp on January 26, 2022, being held virtually and in a condensed format due to the COVID-19 pandemic.
Be empowered to navigate the Digital Health Technology development and evaluation journey from patient needs assessment, to product development and validation tailored to supporting the context of use, to measuring patient outcomes and preferences.
The hands-on training will provide an opportunity for early-stage innovators to become fluent with terminology and aware of regulatory considerations and resources, enabling them to:
- Have more informed interactions with regulators.
- Improve their evidence generation.
- Bring safe and effective medical technologies into the healthcare system in a timely manner.
The emphasis of this bootcamp will be on Digital Health Technologies used to facilitate assessment of patient outcomes in clinical trials (i.e., Clinical Outcome Assessments (COAs)).
NOTE: This bootcamp is targeted to beginner and intermediate learners.
Participants are required to complete an initial interest form by no later than November 18th, and will be notified if they are selected and invited to register for attendance. There is no registration fee.
Questions?
For more information, please contact Allen Chen, Ph.D., U.S. Food and Drug Administration, or cersi@umd.edu.