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 who have experience using RWD/RWE at member companies of the Pharmaceutical Manufacturers Association of Japan (PMAJ) and who are aware of the issues involved in using RWD/RWE were gathered to identify and prioritize 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 in May 2025
Committee on Drug Evaluation, Japan Pharmaceutical Manufacturers Association
TF for Promotion of Utilization of Medical Information DB ST2
Report of the Roundtable on Prioritization of Issues for Utilization of RWD and RWE
Deliverables of the Drug Evaluation Committee Return to list of all deliverables