ICSR Submission In E2B(R3) Format

Changing EMA regulations will require ICSR submissions in E2B(R3) format. If you are looking to adopt a technical solution for E2B(R2) to E2B(R3) XML automatic conversion tool according to BFC (backward-forward conversion), Think-i offers you the complete solution for Oracle Argus, ArisG and other safety databases.

• Covert and submit ICSRs automatically without adding additional workload on data processing.

• The returned MDN and Acknowledgments would be mapped back to your application for global compliance overview and monitoring.

• Additional Health Authorities worldwide have already announced the transition to E2B (R3) submission during 2022-2023. The solution is scalable to support the introduction of additional submission contacts as required.