Drug Evaluation Committee Meeting to Consider Smooth Implementation of Electronic Data Submission for Applications: "Results of Questionnaire on Consultation for Exemption from Electronic Data Submission for Applications" and "Information Sharing on SDTMIG v3.3, Define-XML v2.1"
Data Science Expert Committee
June 2024
The Japan Pharmaceutical Manufacturers Association (JPMA) Drug Evaluation Committee, Data Science Subcommittee, Task Force 6 in 2023 has been working to promote smooth submission of electronic data for regulatory applications and effective utilization of CDISC compliant data in light of changes in the 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 think about "how to implement the work smoothly" and 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