Drug Evaluation Committee Report of the Roundtable on Prioritization of Issues for Utilization of RWD and RWE

Medical Information DBTF

May 2025

This document is a report summarizing the discussions held on November 20, 2024 at the "Roundtable on Issue Arrangement/Prioritization for Utilization of RWD and RWE". Experts from JPMA member companies who have experience using RWD/RWE and are aware of the issues involved in its use were gathered to identify and prioritize the issues. The discussions were organized into four areas: clinical development, medical affairs, post-marketing safety, and HEOR/HTA.
We hope that the issues organized in this report will be helpful in considering measures to promote the use of RWD/RWE.

Published May 2025
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
TF ST2 for Promotion of Utilization of Medical Information DB

Report of the Roundtable on Prioritization of Issues for Utilization of RWD and RWE

 Executive Summary

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