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Electronic Submission of Safety Reports using E2B R3 standard - Ready for Primetime?
Session Chair(s)
Suranjan De, MBA, MS
Deputy Director, Regulatory Science, OSE, CDER
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; Discuss reporting scenarios, system readiness, testing approach, challenges and lesson learned both from FDA’s and industry’s perspective.
Speaker(s)
Beyond Borders: Navigating the Complexities of ICH E2B R3 Regional Implementations
Una Kessi
Oracle Health & Life Sciences, United Kingdom
Product Management Director, Safety and Pharmacovigilance
Industry Perspective: ICH E2B R3 Regional Implementations
Donald Williams
Boehringer Ingelheim Pharmaceuticals, Inc., United States
Global Patient Safety and Pharmacovigilance, Regulatory Reporting