Drug Evaluation Committee Workshop for Practitioners on Electronic Data Submission at the Time of Application
Feb 21, 2022
- 00_Program (277KB)
- 01_CJUG ADaM Team sharing survey results (4.9MB)
- 02_Case Studies on Validation Issues (544KB)
- 03_Discussion of questionnaire results on Legacy data conversion (421KB)
- 04_Where to start? How to use the FDA Package of In-licensed Products for PMDA Application (2.3MB)
- 05_Case study report on electronic data submission of physiologically-based drug kinetics (PBPK) and exposure-response (E-R) model analysis results (1.1MB)
- 06. Current status and points to note regarding electronic data submission (1.3MB)
- 07_What will change in the era of eCTDv4 (976KB)
- 08_Examples of application work and points to note after the change in the operation of consultation on confirmation of electronic data submission of applications (509KB)
- 09_How much of Gateway can be outsourced? Approval "at the time of review" (2.0MB)