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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FDA’s efforts to be responsive to this rapidly evolving technological ecosystem the FDA will provide an overview of the draft guidance titled Digital Health Technologies for Remote Data Acquisition in Clinical Investigations Guidance for Industry, Investigators, and Other Stakeholders.

TOPICS COVERED

• 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

INTENDED 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
Clinical Methodologies | Office of Medical Policy (OMP)
Center for Drug Evaluation (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 (OSPTI)
Center for Devices and Radiological Health (CDRH) | FDA

Matthew Diamond, MD, PhD
Chief Medical Officer for Digital Health
Digital Health Center of Excellence |OSPTI | CDRH | FDA

Christina Webber, PhD
Regulatory Science Program Manager
Division of All Hazards Response, Science, and Strategic Partnerships | OSPTI | CDRH | FDA

FDA RESOURCES

• CDRH Digital Health Center of Excellence
• FDA digital health regulatory policies
• CDER’s Drug Development Tools (DDT) Qualification Programs
• Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program
• CDRH’s Medical Device Development Tools (MDDT) Qualification Programs

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 has been:

• 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.

TECHNICAL INFORMATION

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