| PHUSE US |
2026 |
Incorporating Digital Health Technology (DHT) Data in SDTM - Challenges and Examples |
Swarupa Sudini |
source
poster source |
7 |
| PHUSE US |
2025 |
Collaborating on Standards: An Approach to Harmonizing Vaccine Regulatory Submissions |
Fred Bermont,
Médéric Celle,
Estella Sani,
Erin Gnas,
Jennifer Mastri,
Leslie Morgan,
Naila Musani,
Ramana Setty,
Yun Zhang |
source
presentation source |
8 |
| PHUSE US |
2024 |
Incorporating Real-World Data in a Low-Interventional Study: Challenges and Considerations |
|
source
presentation source |
8 |
| PHUSE US |
2023 |
Challenges Addressing CBER Guidance on Reactogenicity, from Collection to Analysis |
Emily Bernstein-Hanlon |
source
presentation source |
12 |
| PharmaSUG |
2014 |
Reducing Variable Lengths for Submission Dataset Size Reduction |
|
source |
6 |
| SGF |
2012 |
SUPPQUALWhere's My Mommy? |
|
source |
8 |
| PharmaSUG |
2011 |
Validating define.xml: Tools, trials, and tribulations |
|
source |
5 |
| PharmaSUG |
2010 |
Quality in a World of "Standards" with Differences! |
|
|
9 |
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