SBIA Webinar: FDA Safety Report Type Flag Requirement for FAERS Submissions

Registration Open

FDA | CDER | Small Business and Industry Assistance  WEBINARS FDA Safety Report Type Flag Requirement for FAERS Submissions February 19, 2021 | 1:00 - 2:00 p.m. Eastern This webinar is FREE. Register FDA will introduce the FAERS FDA Safety Report Type Flag and communicate how to prepare for this new requirement. TOPICS Discuss and define the FDA Safety Report Type Flag Highlight benefits associated with the requirement Communicate implementation considerations AUDIENCE Members of the pharmaceutical industry responsible for the submission of adverse event reports to the FDA. If accessing webinar in a browser, use Chrome for optimum viewing. CONTINUING EDUCATION Real-time attendance is required for the certificate of attendance. Certificates are only available during the two weeks post-event. This course: has been pre-approved by RAPS as eligible for up to 1 credits towards a participant's RAC recertification upon full completion. has been 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. has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant's RQAP re-registration. has been 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 Subscribe to CDER SBIA Email Updates View 2021 Recordings on YouTube Follow on LinkedIn Follow on Twitter

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