Drug Evaluation Committee Meeting on Smooth Implementation of Electronic Data Submission: "Results of Questionnaire on Consultation on Exemption from Electronic Data Submission" and "Information Sharing on SDTMIG v3.3 and Define-XML v2.1".
Data Science Subcommittee
June 2024
The Japan Pharmaceutical Manufacturers Association (JPMA) Drug Evaluation Committee, Data Science Subcommittee, Task Force 6 in 2023 has been working to promote the smooth submission of electronic data for regulatory applications and the effective use of CDISC compliant data in light of the changing circumstances surrounding electronic data submission.
As part of our activities, we held the "Meeting to Consider Smooth Implementation of Electronic Data Submission for Applications" in March 2024 for member companies of the Data Science Subcommittee as a place for those involved in electronic data submission for applications to consider "how to implement the work smoothly" and to exchange information on problems in their daily work. The meeting was held in March 2024.
We are pleased to publish the following two presentations that were presented at the meeting as a result of the task force. We hope that these materials will be helpful for your information gathering and operations.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Data Science Subcommittee 2023 Task Force 6