Articles tagged with “safety-reporting”

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

FDA & EMA Inspection Questions: 10-Year Data Analysis

Review 10 years of FDA 483 patterns and EMA reports. Learn the four core inspection question clusters and the specific evidence required for compliance.

45 min read

3/1/2026

clinical trial inspection fda form 483 gcp compliance data integrity vendor oversight informed consent process inspection readiness tmf management safety reporting