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Electronic Submission of Safety Reports using E2B R3 standard - Ready for Primetime?
Session Chair(s)
Representative Invited
FDA, United States
Reporting of safety reports to FAERS using ICH E2B (R3) format. The presenters will discuss scenarios, system readiness, testing approach, challenges and lesson learned for a successful implementation and onboarding.
Learning Objective : Recognize that FDA is live with E2B R3 standard and will require reporting of Investigational New Drug (IND) and postmarket safety reports to be submitted to FAERS. Describe how to prepare and be ready to submit electronically. Understand reporting scenarios, system readiness, testing approach, challenges and lesson learned both from FDA’s and industry’s perspective.
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