FDA Webinar on Electronic Submission of Adverse Event Reports

FDA is hosting a 3-hour webinar on Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards on November 7, 2023.

The purpose is to provide the pharmaceutical industry and other interested parties with updated information on the plans, progress, and technical specifications to upgrade electronic submission standards for the premarket and postmarket safety surveillance programs managed by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

Click on link below for details and to register.

“https://www.fda.gov/drugs/news-events-human-drugs/electronic-systems-electronic-records-and-electronic-signatures-webinar-04252023?utm_medium=email&utm_source=govdelivery”