Digital Health Technologies for Remote Data Acquisition Draft Guidance

Registration is open!

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance WEBINARS Digital Health Technologies for Remote Data Acquisition Draft Guidance February 10, 2022 1:00 p.m. - 2:30 p.m. ET This webinar is FREE. Registration    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FDA's efforts to be responsive to this rapidly evolving technological ecosystem the FDA will provide an overview of the draft guidance titled Digital Health Technologies (DHT) for Remote Data Acquisition in Clinical Investigations Guidance for Industry, Investigators, and Other Stakeholders. 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 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 This webinar is part of the SBIA Regulatory Education for Industry (REdI) series. 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 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 (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 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. The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. Register for Upcoming Training Watch Learning Library Recordings on YouTube Subscribe to CDER SBIA Email Updates Follow on LinkedIn Follow on Twitter

This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.   SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA