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Digital Health Technologies for Remote Data Acquisition Draft Guidance February 10, 2022
1:00 p.m. - 2:30 p.m. ET
This webinar is FREE. About this Webinar Technological advances provide opportunities to facilitate efficient clinical investigations. The FDA intends to provide the clarity needed to encourage the exploration of these technological advances. As a part of the FDA's efforts to be responsive to this rapidly evolving technological ecosystem, the FDA will provide an overview of the draft guidance titled Digital Health Technologies (DHT) for Remote Data Acquisition in Clinical Investigations Guidance for Industry, Investigators, and Other Stakeholders. Topics - Overview of Digital Health Technologies
- Regulatory Considerations for DHTs for Remote Data Acquisition in Clinical Investigations
- Selecting a DHT for a Clinical Investigation
- Verification, Validation and Usability Studies of DHTs
- Evaluation of Clinical Endpoints from Data Collected Using DHTs
Audience - Individuals developing clinical investigations using DHTs to remotely collect data or who submit investigational new drug (IND) applications and investigational device exemption (IDE) applications.
- Researchers and developers working on DHTs to remotely acquire data.
- Consultants focused on designing clinical investigations to use DHTs to remotely collect data.
- Clinical research personnel and organizations involved in clinical investigations using DHTs.
- Healthcare professionals, patients and caregivers supporting the modernization of clinical trials.
- Regulators involved in the use of DHTs to remotely acquire data to support marketing applications.
FDA Speakers Leonard Sacks, MBBCh Associate Director, Clinical Methodologies Office of Medical Policy (OMP) | CDER | FDA Elizabeth Kunkoski Health Science Policy Analyst, Clinical Methodologies OMP | CDER | FDA Anindita Saha Assistant Director, Digital Health Center of Excellence | Office of Strategic Partnerships and Technology Innovation (OST) | Center for Devices and Radiological Health (CDRH) | FDA Matthew Diamond, MD, PhD Chief Medical Officer for Digital Health, Digital Health Center of Excellence | OST | CDRH | FDA Christina Webber, PhD Regulatory Science Program Manager, Division of All Hazards Response, Science, and Strategic Partnerships | OST | CDRH | FDA FDA Resources This webinar is part of the SBIA Regulatory Education for Industry (REdI) series. Continuing Education Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event. This course is: - pre-approved by RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant's RAC recertification upon full completion.
- pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
- pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant's RQAP re-registration.
- approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.
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