Drug Evaluation Committee Materials for "Workshop for Practitioners on Electronic Data Submission at the Time of Application" in FY2022
Mar 02, 2023
- 00_Program (170KB)
- 01_Examination of the relationship between explanatory materials (Form A) and data guides for electronic data at the time of application (1.84MB)
- 02. Proposal of Best Practice for electronic data submission using data prepared by other companies (3.94MB)
- 03_Electronic Data Submission for PPK Analysis: What You Need to Know (3.84MB)
- 04_Questionnaire results on the impact of eCTD v4.0 on the electronic data submission process (886KB)
- 05. Points that CDISC staff of CROs should pay attention to when complying with eCTD V4.0 (862KB)
- 06_Current Status and Points to Consider Concerning Electronic Data Submission of Applications (840KB)
- 07_Update on eCTD v4 and Gateway (1.96MB)
- 08_Introduction of internal process study for electronic data submission of applications with eCTD Ver. 4.0 (1.31MB)
- 09_Best Practices for Early Transition to Online Submission as Communicated by Regulatory Affairs Operations Involved in Gateway Submission from the Early Days (1.38MB)