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Bethesda North Marriott Hotel and Conference Center

Feb 06, 2023 1:00 PM - Feb 09, 2023 12:35 AM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Global Pharmacovigilance and Risk Management Strategies Conference

Stay current with the latest safety regulations from global health authorities and regulatory experts!

Session 4: FDA Technical Specification for Implementing E2B R3

Session Chair(s)

Jo  Wyeth, PharmD

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


Suranjan  De, MBA, MS

Reporting of Premarket and Postmarket Safety Reports to FDA using ICH E2B(R3) Standards

Suranjan De, MBA, MS

FDA, United States

Deputy Director, Regulatory Science, OSE, CDER

Y. Veronica  Pei, MD, MEd, MPH

Safety Reporting for INDs and IND-exempt BA/BE Studies to FDA using ICH E2B(R3) Standards

Y. Veronica Pei, MD, MEd, MPH

FDA, United States

Acting Associate Director, Biomedical Informatics and Regulatory Review Science

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