Final Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations

The foodstuff and Drug Administration, Centre for Drug Evaluation and Research and Small Enterprise and Industry Assistance (CDER SBIA), welcomes you to our webinar series.

These types of events concentrate on a specific topic and provide the opportunity for small business and industry entities to learn more about the FDA and basic drug regulation. The training calls support CDER SBIA’s mission of promoting productive connection with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human medicine products.

Issuing the guidance for industry on the utilization of electronic heath report (EHR) data in medical investigations is part of the agency’s commitment to furthering the advancement and use of recent technologies in scientific and regulatory techniques. The goals of the guidance are to:

Modernize and streamline clinical investigations.
Promote the interoperability of EHR and EDC systems by encouraging sponsors and health care organizations to utilize EHR and electronic data capture (EDC) vendors to further progress the interoperability and incorporation of EHRs and EDC systems.
This webinar provides insight on FDA’s suggestions on the use of EHR data in FDA-regulated clinical investigations.

WHY GO TO?

• Hear directly from the FDA experts on using EHR data in clinical investigations
•  Require a deep dive into the suggestions presented in the final assistance document

WHO SHOULD ATTEND?

• Regulatory affairs professionals
•  Researchers
• Clinical investigators
• Sponsors
• CROs
• IRBs
• Foreign regulators
•  Experts
• Clinical research coordinators
• EHR and EDC technology sellers
• Other stakeholders thinking about using EHR data in clinical investigations
• CONTINUING EDUCATION

This one-hour live webinar is RAPS eligible for upwards to 1. 0 credit towards a participant’s RAC recertification after full finalization.
This event is SQA approved for 0. twenty-five non-GCP or non-GLP units per 1 hour towards RQAP re-registration.
Attendance Records are only available for A COUPLE OF WEEKS after the event. Please note that the credit is only available for participation in the live event and not for observing the recording afterwards.