CDER SBIA Webinar: Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards - Oct. 11, 2019

Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards Friday, Oct. 11, 2019 | 1:00 p.m. - 2:00 p.m. Eastern | This webinar is FREE.

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TOPICS COVERED FAERS II and E2B R3 Up Versioning Plans Describe the objective, scope and timeline of E2B R3 regional implementation E2B(R3) Regional Data Elements Premarket safety reporting regional requirements Postmarket safety reporting regional requirements Postmarket combination product regional requirements Updates on electronic submission routing mechanisms Describe the different routing mechanisms to submit via ESG or Safety Reporting Portal Testing ICH E2B (R3) Regional XML files Describe the methods to test ICH E2B (R3) regional XMLs

INTENDED AUDIENCE Pharmacovigilance experts focused on implementing safety databases and submitting safety reports to regulatory agencies Regulatory affairs professionals who submit premarket safety reports Consultants working to implement ICH E2B (R3) standards

FDA SPEAKER Suranjan De, MS, MBA Deputy Director Regulatory Science Staff (RSS) | Office of Surveillance & Epidemiology | CDER | FDA