| PharmaSUG |
2023 |
Study Data Technical Rejection Criteria (TRC) Considerations for Multiple Data Packages in a Single Submission |
Christine S Teng,
Si Ru Tang |
source |
10 |
| PHUSE US |
2020 |
Industry Experiences Submitting Standardized Study Data to Regulatory Authorities |
Vincent Guo |
source
presentation source |
12 |
| PHUSE US |
2020 |
What You Need to Know About Submitting Data to the FDA |
Pritesh Solanki |
source
presentation source |
7 |
| PharmaSUG |
2019 |
Sponsor Considerations for Building a Reviewer's Guide to Facilitate BIMO (Bioresearch Monitoring) Review |
Kiran Kumar Kundarapu,
Majdoub Haloui |
source |
5 |
| PHUSE US |
2019 |
Striking a Balance: Adoption of Analysis Results Metadata (ARM) in Early Development Studies |
Pranab K. Mitra |
source
presentation source |
6 |
| PHUSE US |
2019 |
What Does Good Look Like in the Study Data Standardization Plan (SDSP)? |
Pritesh Solanki |
source
presentation source |
5 |
| PHUSE US |
2018 |
Comparing and Contrasting Differences between the PHUSE SDSP and CBER Checklist |
Pritesh Solanki |
source
presentation source |
5 |
| PharmaSUG |
2011 |
Using Six Sigma Methodologies to Find a Solution for Increasing Training Completions |
Eunice Ndungu,
Shazia Khawaja,
Steve Miola |
source |
22 |
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