| PHUSE US |
2026 |
Scaling for the Future: Transitioning from In-House to Commercial Statistical Computing Environments |
Hemu Shere |
source
presentation source |
8 |
| PharmaSUG |
2023 |
Consistency Checks Automation across Regulatory Submission Documents in the eCTD M5 folder |
Loganathan Ramasamy,
Hemu Shere |
source |
8 |
| PharmaSUG |
2022 |
Including Population Information in ADaM define.xml for Better Understanding of Datasets |
Hong Qi,
Guowei Wu |
source |
6 |
| PharmaSUG |
2022 |
Lessons Learned from Using P21 to Create ADaM define.xml with Examples |
Yizhuo Zhong,
Christine S Teng |
source |
8 |
| PHUSE US |
2021 |
China Center for Drug Evaluation, NMPA Electronic Study Data Submission Requirements [presentation] |
Yanhong Li |
source
video |
16 |
| PharmaSUG |
2020 |
Analysis Package e-Submission - Planning and Execution |
Abhilash Chimbirithy,
Saigovind Chenna |
source |
8 |
| PharmaSUG |
2020 |
Supplementary Steps to Create a More Precise ADaM define.xml in Pinnacle 21 Enterprise |
Hong Qi |
source |
10 |
| PharmaSUG |
2019 |
Sponsor Considerations for Building a Reviewer's Guide to Facilitate BIMO (Bioresearch Monitoring) Review |
Kiran Kumar Kundarapu,
Janet Low |
source |
5 |
| PHUSE US |
2019 |
High-quality Study Data Standards for Submission |
Ellen L. Asam |
source
presentation source |
9 |
| PharmaSUG |
2018 |
eSubmission - Are you really Compliant? |
Suhas R. Sanjee |
source |
5 |
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