| PHUSE APAC |
2026 |
Accelerating Regulatory Submissions with R: A Scalable and Compliant Approach |
Priyanka Sawant |
source
presentation source |
6 |
| PHUSE EU |
2025 |
Validated Statistical Computing: A Kubernetes Framework for Regulatory-Compliant R, Python and SAS Deployments |
T. Randall Betancourt,
Tim Fantuzzo |
source
presentation source |
53 |
| PHUSE US |
2025 |
Can AI Help Overcome the Validation Burden for Open Source? |
Marc Jantke |
source
presentation source |
8 |
| PharmaSUG |
2022 |
Vendor Audit: What it is and What to Expect from it |
Parag Shiralkar,
Nagadip Rao |
source |
6 |
| PHUSE US |
2022 |
Applications of the R Package Validation Framework and {valtools} [presentation] |
Ellis Hughes |
source
video |
34 |
| PHUSE US |
2021 |
Data Visualizations for Publication, Decision-making and Submission [presentation] |
Maria Dalton |
source
video |
18 |
| PHUSE US |
2021 |
Statistical Computing Environment White Paper |
Jorine Putter,
Mark Bynens |
source
pdf
video |
45 |
| PHUSE EU |
2020 |
Successful and Optimised Project Delivery by Embracing Agile in a Validated Environment [presentation] |
Andy Ratcliffe,
Chris Cowling |
source
video |
34 |
| PHUSE EU |
2018 |
The Importance of Being Ernest - Risk-based Approach (RBA) |
William Andrew Lawton |
source
presentation source |
4 |
| PharmaSUG |
2018 |
Validating R - Part of the Uphill Battle in the Pharmaceutical Industry |
Peter Schaefer,
Debra Fontana |
source |
10 |
| PharmaSUG CN |
2012 |
Rising to Excellence - How a China CRO Achieves International Standards [presentation] |
Helen Yin,
Minzhi Liu |
|
27 |
| PHUSE EU |
2010 |
Vendor Selection & Management in GxP critical IT projects - a validation perspective (based on actual case) [presentation] |
Claus le Fevre |
source |
19 |
| PHUSE EU |
2009 |
Database/Biostatistics Audits - from the Auditor's Perspective |
Barry Ryan |
source
presentation source |
7 |
| SESUG |
2008 |
Architecting a Regulatory Compliant Macro Library Using SAS Drug Development |
Virginia Redner,
Margaret M. Coughlin |
source |
5 |
| PHUSE EU |
2008 |
An approach to Version Control with SAS |
John Woods,
Paul Crean |
source |
12 |
| PHUSE EU |
2008 |
Automating Production of Validation Documentation |
Tangi Sanséau |
source |
10 |
| PharmaSUG |
2007 |
Architecting a Regulatory Compliant Macro Library Using SAS Drug Development |
Virginia Redner,
Margaret M. Coughlin |
|
6 |
| PHUSE EU |
2005 |
QualityView - a SAS program database and validation documentation tool |
Peter Gerber,
Michael Ludwig |
source |
12 |
| PharmaSUG |
2005 |
A Simple Solution for Managing the Validation of SAS Programs That Support Regulatory Submissions |
Tony Chang,
Dana Soloff |
|
6 |
| PharmaSUG |
2005 |
Managing a SAS Programming Environment Using Data Access Pages and the Microsoft Office Data Source Control |
Brian P. Fairfield-Carter |
|
12 |
| SUGI |
2005 |
Managing a SAS Programming Environment Using Data Access Pages and the Microsoft Office Data Source Control |
Brian P. Fairfield-Carter |
source |
10 |
| SUGI |
2003 |
A Programming Development Environment for SAS Programs |
Tim P. Williams,
Lee Walke |
source |
6 |
| SESUG |
2002 |
A Programming Development Environment for SAS Programs |
Tim P. Williams |
source |
10 |
| SEUGI |
2002 |
SAS and the CRO [presentation] |
Peter Stagg |
source |
14 |
| SEUGI |
2001 |
Software Validation in Clinical Trial Reporting: Experiences from the Biostatistical & Data Sciences Department [presentation] |
Andrea Baker |
source |
25 |
| PharmaSUG |
1997 |
System Development Life Cycle for SAS Applications Development Incorporating a Procedure for As-Built Validation of In-Use Products |
Wayne Lanier |
|
7 |
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