Drug Evaluation Committee October 31, 2025 "Model Credibility Evaluation in Drug Development"
August 27, 2025
In recent years, guidelines related to MIDD (Model Informed Drug Development) have been issued in Japan in addition to overseas regulatory authorities such as FDA (USA) and EMA (Europe). In addition, the ICH for international harmonization has reached the stage of soliciting public comments as M15, and discussions on MIDD by industry, government, and academia have begun to gain momentum in earnest.
In order to effectively utilize mathematical models in drug development, one of the important processes is to clarify the purpose and limitations of the models and to appropriately evaluate the reliability of the model predictions. The evaluation of model credibility is one of the main focuses of ICH M15 mentioned above, and it is expected to become extremely important in the future development of MIDDs.
In light of this situation, the Pharmaceutical Manufacturers Association of Japan (PMA) Data Science Subcommittee Continuing Task Force 4 (MIDD Task Force) in FY2024/2025 prepared and published a report on Model Credibility evaluation in drug development. In this symposium, the contents of this report will be introduced, and an external lecturer will give an overview of the efforts in the mechanical and medical device fields that have already adopted Model Credibility evaluation. In addition, we would like to invite members of the EWG of ICH M15 to participate in a panel discussion to discuss future prospects based on the contents of this deliverable. We hope that this will help you to understand the contents.
Date: Friday, October 31, 2025, 14:00-16:00