Articles tagged with “icsr”

FDA AEMS E2B(R3) Cutover: 2026 Migration Runbook

A 2026 FDA AEMS E2B(R3) cutover runbook covering the October 1 deadline, applicability, R2 transformation risks, ESG NextGen testing, acknowledgements, validation, and hypercare.

20 min read

9/19/2026

fda aems e2b(r3) cutover fda aems e2b(r3)esg nextgen pharmacovigilance icsr safety reporting computer system validation regulatory compliance

E2B(R3) ICSRs: A Guide to Pharmacovigilance Reporting

An in-depth guide to the ICH E2B(R3) standard for pharmacovigilance. Explore the data structure of ICSRs, electronic reporting rules, and key global systems. Updated April 2026.

35 min read

1/9/2026

e2b(r3)icsr pharmacovigilance ich e2b(r3)electronic reporting drug safety hl7 eudravigilance data harmonization

AI Agents in Pharmacovigilance: A Technical Overview

An overview of AI agents in pharmacovigilance (PV), covering agentic AI, generative AI, and ML applications in safety data processing, ICSR management, and signal detection, with updates on the CIOMS WG XIV final report, FDA's Elsa tool, and EU AI Act requirements.

70 min read

8/26/2025

pharmacovigilance ai agents drug safety adverse event reporting case processing health informatics icsr ai