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regulatory reporting

9 papers and 7 presentations; 16 titles.

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Conference × Year × Title × Authors Extras Pages
PharmaSUG 2026 Operationalizing Generative AI in Regulated Analytics: Applied Implementation Patterns for Enterprise Deployment Lida Gharibvand source 16
PharmaSUG 2026 Python for Survival Analysis: Kaplan-Meier and Reverse KM Plots Made Easy Girish Kankipati,
Bala Rajesh Jakka
source 20
PharmaSUG 2026 R-Based Translation of Japanese Characters in Clinical Datasets for Regulatory Reporting Hardik Sheth,
Roshan Stanly
source 7
PHUSE US 2023 An Open-Sourced R Package for Streamlining Generation of Standard TLFs in Both Static and Interactive Formats [presentation] Lena Wang,
Heng Wang
source
video
25
PHUSE US 2023 Visual Guidance: Monitoring Data Fitness and Study Progress in an SCE [presentation] Jörn Bilow source
video
12
PHUSE US 2021 Is it ART? An Application of TransCelerate's MoA Framework for Assessing Accuracy, Reproducibility and Traceability in Novel Software Implementations [presentation] Michael S Rimler,
Tim Kuhn
source 20
PHUSE US 2021 Open-Source Development for Traditional Clinical Reporting [presentation] Michael Stackhouse,
Nathan Kosiba
source
video
12
PHUSE EU 2020 Use Cases of Google Sheets in Programming Applications [presentation] Carina Hillenbach source
video
16
PharmaSUG 2020 Moving A Hybrid Organization Towards CDISC Standardization Kobie O'Brian,
Sara Shoemaker,
Robert Kleemann,
Kate Ostbye
source 8
WUSS 2019 Python applications in SAS programming for medical device clinical trial studies Jianlin Li source 7
PharmaSUG 2018 When a Clinical Trial Lasts Forever: A Reporting Solution for Post-Market Surveillance of Cardiac Rhythm Devices Becky DeBus source 8
PHUSE EU 2015 Exploratory Analysis vs Regulatory Reporting Mijanur Rahman source
presentation source
3
PHUSE EU 2014 Programming and Statistics in the Academics Environment [presentation] Arne Ring source 21
PharmaSUG 2004 %Cox_PH - An enhancement of SAS PROC PHREG Hong (Lily) Zhang,
Robin Mogg
8
SEUGI 2000 Dot-com Your CRM [presentation] Karen Richards source 45
SEUGI 1997 Managing financial reporting requirements Peter Bull source 15

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