Drug Evaluation Committee Workshop "Smooth Submission of Electronic Data and Effective Utilization of CDISC Compliant Data" Presentation Material: Report on the Results of Questionnaire on "Inquiry Items for Electronic Data" and "Handling of Deviation Information and Case Acceptance/Rejection".
Aug 01, 2025
The Japan Pharmaceutical Manufacturers Association (JPMA) Drug Evaluation Committee, Data Science Subcommittee, Continuing Task Force 3 in 2024 has been working to promote the smooth submission of electronic data for regulatory submissions and the effective use of CDISC compliant data in light of the changing circumstances surrounding electronic data submission. As part of our activities, we will hold a workshop "Smooth Submission of Electronic Data for Applications and Effective Utilization of CDISC-compliant Data" in June 2025 for member companies of the Data Science Subcommittee as a place for those involved in electronic data submission to think about "how to implement the work smoothly" and exchange information on problems they encounter in their daily work. The workshop was held in June 2025 for member companies of the Data Science Subcommittee. We are pleased to present the following two presentations as a result of the task force at this meeting. We hope that these materials will be helpful for your information gathering and operations.