CDER SBIA Webinar: Final Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations – Dec. 6, 2018 @ 1 PM EDT

CDER SBIA Webinar: Final Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations  Thursday December 6, 2018  1:00 PM – 2:00 PM EDT View Agenda and Register Here   Issuing the guidance for industry on the use of electronic heath record (EHR) data in clinical investigations is part of the agency’s commitment to furthering the advancement and usage of new technologies in scientific and regulatory processes.  The goals of the guidance are to modernize and streamline clinical investigations; and promote the interoperability of EHR and EDC systems by encouraging sponsors and health care organizations to work with EHR and electronic data capture (EDC) vendors to further advance the interoperability and integration of EHRs and EDC systems. This webinar will provide insight on FDA’s recommendations on the use of EHR data in FDA-regulated clinical investigations. WHY ATTEND? Hear directly from the FDA experts on using EHR data in clinical investigations Take a deep dive into the recommendations presented in the final guidance document WHO SHOULD ATTEND? Regulatory affairs professionals Researchers Clinical investigators Sponsors CROs IRBs Foreign regulators Consultants Clinical research coordinators EHR and EDC technology vendors Other stakeholders interested in using EHR data in clinical investigations CONTINUING EDUCATION This one-hour live webinar is RAPS eligible for up to 1.0 credit towards a participant’s RAC recertification upon full completion. This event is SQA approved for 0.25 non-GCP or non-GLP units per 1 hour towards RQAP re-registration.            Attendance Certificates are only available for TWO WEEKS after the event. Please note that the credit is only available for participation in the live event and not for watching the recording afterwards. RESOURCES: Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations (PDF - 327KB)