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 U.S. Food and Drug Administration, the Yale University and Mayo Clinic CERSI and the Yale School of Medicine Center for Outcomes Research and Evaluation (CORE) for an immersive mini-boot camp March 9, 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:
The emphasis of this boot camp 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.
This event is brought to you by the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), Yale University-Mayo Clinic Center of Excellence in Regulatory Science and Innovation (CERSI), the Yale School of Medicine Center for Outcomes Research and Evaluation (CORE), and the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery.
This is an invitation-only event. Participants are required to complete an interest form/application and will be notified if they are selected and invited to attend. There is no registration fee.
Requests for invitations will be accepted through Feb. 10, 1 p.m. Eastern Time (Noon Central Time).
Pre-boot camp activities: Selected participants must complete approximately one hour of pre-boot camp activities on their own in advance of the live event.
All instructors for the Impact Bootcamp hold leadership roles at the U.S. Food and Drug Administration.
Tags: artificial intelligence, Center for the Science of Health Care Delivery, clinical trials, digital health, Education, FDA, health technology, medical innovation, News, Opportunities, patient reported outcomes, research, research education, Yale