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Session 4: FDA Technical Specification for Implementing E2B R3
Session Chair(s)
Jo Wyeth, PHARMD
Associate Director for Postmarket Assessments, OMEPRM, OSE, CDER, FDA, United States
In preparation for the electronic transmission of safety reports in the ICH E2B (R3) format, FDA recently posted documents that included guidance, technical specifications, conformance, and regional data elements. This session will review requirements for submitting safety reports for INDs, IND-exempt BA/BE studies, and approved drug products using the ICH E2B(R3) format. In addition, this session will highlight variations between the core and regional data elements.
Learning Objective : At the conclusion of this session, participants should be able to:
- Recognize that FDA will require reporting of Investigational New Drug (IND) and post market safety reports to be submitted in the ICH E2B (R3) format to FAERS via the FDA Gateway or using the Safety Reporting Portal
- Describe regional data elements that are key for post market, IND, and IND-exempt BA/BE safety reporting
Speaker(s)
Suranjan De, MBA, MS
Deputy Director, Regulatory Science, OSE, CDER, FDA, United States
Reporting of Premarket and Postmarket Safety Reports to FDA using ICH E2B(R3) Standards
Y. Veronica Pei, MD, MPH
Deputy Division Director, FDA, United States
Safety Reporting for INDs and IND-exempt BA/BE Studies to FDA using ICH E2B(R3) Standards
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