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PhUSE proceedings: Regulatory, 79 papers

Pharmaceutical Users Software Exchange 2017   October 8-11, 2017 - Edinburgh, Scotland

tweet!  Implementing JumpStart at Novo Nordisk A/S
  Kina Ulkaer Jørgensen, Novo Nordisk
Pages: 4 Size: 141 Kb    Download the presentationdownload (.pdf, 2975 Kb)
tweet!  Evaluation of Re-identification Risk for Anonymized Clinical Documents
  Parvee Kumar, GCE Solutions; Rajan Sareen, GCE Solutions
Keywords: De-identification Anonymization data sharing Policy 0070 re-identification risk clinical documents
Pages: 7 Size: 340 Kb    Download the presentationdownload (.pdf, 3992 Kb)
tweet!  The Impact of Regulations on Immuno-Oncology Submissions
  Geoffrey Mann, SAS Institute, JMP Division
Pages: 8 Size: 285 Kb    Download the presentationdownload (.pdf, 288 Kb)
tweet!  An FDA Submission Experience Using the CDISC Standards
  Angelo Tinazzi, Cytel; Cedric Marchand, Cytel
Keywords: data submissiong FDA CDISC SDTM ADAM define.xml SDRG ADRG pooling ISS ISE
Pages: 15 Size: 1925 Kb    Download the presentationdownload (.pdf, 4587 Kb)
Best Presentation
tweet!  Extension Studies - CDISC Submission Challenges and Scenarios
  Arvind Sri Krishna Mani, Zifo RnD Solutions; Deepak Anathan, Zifo RnD Solutions; Sachin Bharadia, Zifo RnD Solutions
Keywords: CDISC Extension studies
Pages: 3 Size: 245 Kb    Download the presentationdownload (.pdf, 1042 Kb)
tweet!  Assessing New CFDA Requirements on Data Integrity Using Risk-Based Monitoring and Enrolment Pattern
  Wenjun Bao, SAS Institute; Richard Zink, SAS Institute
Keywords: *$%NAB
Pages: 13 Size: 1090 Kb    Download the presentationdownload (.pdf, 6203 Kb)

Pharmaceutical Users Software Exchange 2016   October 9-12, 2016 - Barcelona, Spain

tweet!  What is high quality study metadata?
  Sergiy Sirichenko, Pinnacle 21, Plymouth Meeting, PA, USA; Max Kanevsky, Pinnacle 21, Plymouth Meeting, PA, USA
Pages: 9 Size: 384 Kb    Download the presentationdownload (.pdf, 728 Kb)
Best Presentation
tweet!  Planning for Data Reporting Processes for Submission: Key Considerations
  Parag Shiralkar, MBA, M.S., Director, Biometrics Operations and Strategy
Pages: 2 Size: 39 Kb    Download the presentationdownload (.pdf, 567 Kb)
tweet!  Japanese Electronic Study Data Submission in CDISC Formats
  Yuichi Nakajima, Novartis Pharma K.K, Tokyo, Japan; Takashi Kitahara, Novartis Pharma K.K, Tokyo, Japan; Ryan Hara, Novartis Pharma AG, Basel, Switzerland
Keywords: PMDA FDA CDISC electronic study data submission Pinncale 21 legacy data consultation
Pages: 8 Size: 294 Kb    Download the presentationdownload (.pdf, 1232 Kb)
tweet!  What auditors want
  Cedric Marchand, Cytel Inc., Geneva, Switzerland; Angelo Tinazzi, Cytel Inc., Geneva, Switzerland
Pages: 8 Size: 396 Kb    Download the presentationdownload (.pdf, 1072 Kb)
tweet!  Case Study in Support of German Payer Evidence
  Frank Senk, GCE Solutions, Bloomington, IL, USA
Pages: 5 Size: 212 Kb    Download the presentationdownload (.pdf, 270 Kb)

Pharmaceutical Users Software Exchange 2014   October 12-15, 2014 - London, United Kingdom

tweet!  Signal Detection of Misconduct in Clinical Trials
  Geoffrey Mann, SAS Institute JMP Division
Keywords: clinical
Pages: 7 Size: 632 Kb    Download the presentationdownload (.pdf, 766 Kb)
tweet!  Transparency in the Time of Constant Change
  Todd Case, Biogen Idec
Pages: 4 Size: 156 Kb    Download the presentationdownload (.pdf, 804 Kb)
Best Presentation
tweet!  Japanese Submission/Approval from Programming Perspective
  Ryan Hara, Novartis
Pages: 5 Size: 283 Kb    Download the presentationdownload (.pdf, 598 Kb)
tweet!  Submitting Summary Level Site Data: Overview, Implementation and Case Studies
  Robert Woolson, Rho; Jeff Abolafia, Rho
Pages: 9 Size: 265 Kb    Download the presentationdownload (.pdf, 1113 Kb)
tweet!  FDA Guidance on Standardised Study Data for Electronics Submissions
  Lauren Shinaberry, Business & Decision Life Sciences; Éanna Kiely, Business & Decision Life Sciences
Pages: 7 Size: 449 Kb    Download the presentationdownload (.pdf, 4608 Kb)
tweet!  Traceability: Plan Ahead for Future Needs
  Sandra Minjoe, Accenture
Pages: 8 Size: 338 Kb    Download the presentationdownload (.pdf, 1219 Kb)
tweet!  The Quality System in Good Pharmacovigilance Practice (GVP)
  Veronique Chapalain, Keyrus
Pages: 9 Size: 376 Kb    Download the presentationdownload (.pdf, 2745 Kb)
tweet!  Update on Regulatory Guidance: Data Standardisation Planning for Clinical Development Programs
  James Johnson, Summit Analytical
Keywords: clinical
Pages: 10 Size: 494 Kb    Download the presentationdownload (.pdf, 1545 Kb)

Pharmaceutical Users Software Exchange 2013   October 13-16, 2013 - Brussels, Belgium

Orphan Indication Therapies: Programming for a Patient Population without Options
  Todd Case, Biogen Idec
  Download the presentationdownload (.pdf, 724 Kb)
CDISC Journey on Solid Tumor Studies using RECIST 1.1
  Kevin Lee, Cytel
Keywords: CDISC
  Download the presentationdownload (.pdf, 745 Kb)
Best Presentation
Evolving Regulatory Guidance on the Submission of Standardised Data
  James Johnson, Summit Analytical LLC
  Download the presentationdownload (.pdf, 1481 Kb)
On the Submission's Road with CDISC ADaM
  Romain Jegou, Business & Decision Life Sciences
Keywords: CDISC
  Download the presentationdownload (.pdf, 819 Kb)

Pharmaceutical Users Software Exchange 2012   October 14-17, 2012 - Budapest, Hungary

Regulations in the Healthcare Industry
tweet!  New Approaches to Validation for SaaS-based Clinical Computing Solutions in the Cloud
  Tony Hewer, Medidata Solutions Inc
Keywords: clinical
Pages: 7 Size: 473 Kb    Download the presentationdownload (.pdf, 1944 Kb)
tweet!  To EC or Not EC...that is the Question!
  Hiren Naygandhi, Roche
Pages: 8 Size: 128 Kb    Download the presentationdownload (.pdf, 461 Kb)
tweet!  Cost Effective Standards Implementation: A New Paradigm for the Drug Development Life Cycle
  Jeff Abolafia, Rho; Frank DiIorio, CodeCrafters Inc
Keywords: CDISC Data Standards
Pages: 9 Size: 135 Kb    Download the presentationdownload (.pdf, 3120 Kb)
tweet!  Centralised Risk-based Source Data Verification
  Shafi Chowdhury, Shafi Consultancy; Mokhfur Chowdhury, Shafi Consultancy
Pages: 4 Size: 44 Kb    Download the presentationdownload (.pdf, 926 Kb)
Best Presentation
tweet!  "Bertha.sas" - User Friendly Ways to get Traceability
  Elena Glathe, Bayer Pharma AG
Keywords: Traceability statistical Programming SAS Metadata Rtrace
Pages: 28 Size: 3600 Kb    Download the presentationdownload (.pdf, 10165 Kb)
tweet!  Spotting DILI for FDA Submission
  Nicola Tambascia, Accovion; Sven Greiner, Accovion; Software Development
Pages: 7 Size: 215 Kb    Download the presentationdownload (.pdf, 257 Kb)
tweet!  East6: Software for Desigining, Simulating and Monitoring Group Sequential Trials
  Hrishikesh Kulkarni, Cytel Software & Services Pvt. Ltd; Sheetal Solanki, Cytel Software & Services Pvt. Ltd
Keywords: Study Design Interim Monitoring Simulations Compare Design Canvas
Pages: 12 Size: 1380 Kb    Download the presentationdownload (.pdf, 372 Kb)
tweet!  Reveal: Web-Based Software for the Unique Challenges of Enterprise Clinical Data Search
  Jon Davidson, d-Wise Technologies UK Ltd
Keywords: internet clinical
Pages: 1 Size: 58 Kb    Download the presentationdownload (.pdf, 1383 Kb)
Define.xml for ADaM: From Results to SDTM
  Dimitri Kutsenko, Entimo AG
Keywords: CDISC xml
  Download the presentationdownload (.pdf, 108 Kb)
tweet!  SAS Drug Development 4.1 - Clinical Programming and Workflow
  Mark Weadon, SAS Institute; Mark Lambrecht, SAS Institute
Keywords: clinical
Pages: 8 Size: 554 Kb    Download the presentationdownload (.pdf, 530 Kb)
Clinical Reference Library: Metadata and Standards Management in a Single Tool
  Jonathan Peachey, IBM; Colin Sprink, IBM; Bryan Munday, IBM
Keywords: clinical
tweet!  Master Data Management and Possible Applications for Clinical Trial Data
  Bill Gibson, SAS
Keywords: clinical
Pages: 2 Size: 80 Kb    Download the presentationdownload (.pdf, 439 Kb)

Pharmaceutical Users Software Exchange 2011   October 9-12, 2011 - Brighton, United Kingdom

tweet!  Modular Programming - Some Lessons Learned and Benefits Gained
  Ross Farrugia, Roche Products Limited
Keywords: Modular Programming Unit Testing
Pages: 6 Size: 228 Kb    Download the presentationdownload (.ppt, 1078 Kb)
tweet!  Preparing an eSubmission based on multiple trials, some of which are ongoing -challenges for statistical programmers
  Asa Carlsheimer, Ferring Pharmaceuticals A/S
Pages: 7 Size: 469 Kb    Download the presentationdownload (.ppt, 1633 Kb)
tweet!  FDA CDER Common Data Standards Issues: Evolution of SDTM Submission Standards
  Peter Van Reusel, Business & Decision Life Sciences; Tina Apers, Business & Decision Life Sciences
Keywords: FDA CDISC SDTM submission
Pages: 3 Size: 120 Kb    Download the presentationdownload (.ppt, 2839 Kb)
Understanding NDA/BLA Clinical Data Submission
  Dirk Spruck, Accovion
Keywords: clinical
  Download the presentationdownload (.pdf, 1020 Kb)

Pharmaceutical Users Software Exchange 2010   October 14-17, 2010 - Berlin, Germany

tweet!  A Case Study in Using Unit Testing as a Method of Primary Validation
  Ross Farrugia, Roche Products Limited
Keywords: Unit Testing Validation
Pages: 12 Size: 122 Kb    Download the presentationdownload (.ppt, 660 Kb)
Vendor Selection & Management in GxP critical IT projects - a validation perspective (based on actual case)
  Claus le Fevre, NNIT
  Download the presentationdownload (.pdf, 1828 Kb)
tweet!  How much is it? Validation of Open-Source Software using the example of R
  Peter Bewerunge, HMS Analytical Software
Pages: 7 Size: 359 Kb    Download the presentationdownload (.ppt, 990 Kb)
tweet!  Validation Strategies for Report Objects and Programs - Challenges and Obstacles in a Risk Based World
  Christoph Ziegler, Roche; Beate Hientzsch, Accovion
Pages: 12 Size: 86 Kb    Download the presentationdownload (.ppt, 7298 Kb)
tweet!  Risk Radar for the Outsourcing of Clinical Trials: The Best Guide for Success
  Randy Ramin-Wright, ii4sm; Raffael Jovine, ii4sm
Keywords: QRM Quality Risk Radar Outsourcing Clinical Trials
Pages: 12 Size: 169 Kb    Download the presentationdownload (.pdf, 554 Kb)
tweet!  Good Clinical Practices or "Why we do What we do the Way we do it"
  Elaine Dempsey, Paraxel
Keywords: clinical
Pages: 5 Size: 69 Kb    Download the presentationdownload (.ppt, 213 Kb)

Pharmaceutical Users Software Exchange 2009   October 19-21, 2009 - Basel, Switzerland

tweet!  24 Hour Challenge
  Michael Whitworth, AstraZeneca
Pages: 6 Size: 134 Kb    Download the presentationdownload (.pdf, 258 Kb)
Best Presentation
tweet!  Acceleration through Collaboration
  Carrie Eason, Quintiles
Keywords: Resourcing effective relationships new initiatives at Quintiles
Pages: 7 Size: 86 Kb    Download the presentationdownload (.pdf, 2728 Kb)
tweet!  CRT for eCTD submission
  Aurelien Guillouche, Novartis
Pages: 8 Size: 338 Kb    Download the presentationdownload (.pdf, 251 Kb)
tweet!  Data review: To see or not to see..
  Estelle Tiemtore, Quintiles
Pages: 6 Size: 152 Kb    Download the presentationdownload (.pdf, 946 Kb)
tweet!  Health Authority questions: how to deal with the diversity
  Annabelle Millischer-Foulon, Novartis
Keywords: healthcare
Pages: 5 Size: 45 Kb    Download the presentationdownload (.pdf, 234 Kb)
tweet!  ClinicalTrials.gov- a programmers perspective
  Ralf Minkenberg, Boehringer-Ingelheim
Keywords: Clinical Trials Results Disclosure ClinicalTrials.gov FDAAA
Pages: 6 Size: 271 Kb    Download the presentationdownload (.pdf, 787 Kb)
tweet!  Industry Standard Good Programming Practice for Clinical Trials (using SAS)
  Mark Foxwell, AstraZeneca
Keywords: Good programming practice Wiki collaboration SAS programming standards clinical
Pages: 4 Size: 40 Kb    Download the presentationdownload (.pdf, 322 Kb)

Pharmaceutical Users Software Exchange 2008   October 12-15, 2008 - Manchester, United Kingdom

tweet!  RECIST Temptation
  Paul Jenkins, Quintiles
Keywords: RECIST programming guidelines lesions
Pages: 8 Size: 106 Kb 
Best Presentation
tweet!  Risk Based Approach Applied to the Validation of Report Objects
  Christoph Ziegler, F. Hoffmann-La Roche Ltd
Pages: 8 Size: 210 Kb 
tweet!  Automating Production of Validation Documentation
  Tangi Sanséau, ICON Clinical Research
Keywords: Validation Documentation - Authorities Requirements - Automating
Pages: 10 Size: 565 Kb 
tweet!  Developing a clinical reporting system collaboratively under an Open Source software license.
  Ann M. Martin, UCB Pharma
Keywords: clinical
Pages: 7 Size: 29 Kb 
tweet!  Validation of Clinical Output: More Quality with Less Effort
  Jules van der Zalm, van der, OCS Biometric Support
Keywords: clinical
Pages: 7 Size: 352 Kb 
tweet!  Automatic Unit Testing of SAS programs with SASUnit
  Andreas Mangold, HMS Analytical Software GmbH; Patrick René Warnat, HMS Analytical Software GmbH
Keywords: Testing Unit Test Quality Software Engineering SAS/BASE SAS/Macro GxP Compliance
Pages: 11 Size: 399 Kb 
tweet!  Drug Safety Reporting - now and then
  David Garbutt, Business & Decision
Pages: 22 Size: 1456 Kb 

Pharmaceutical Users Software Exchange 2007   October 8-10, 2007 - Lisbon, Portugal

CDISC and Regulatory
tweet!  Standardizing FDA Data to Improve Success in Pediatric Drug Development
  Julie Maddox, SAS Institute, Cary, NC, USA; Chris Decker, SAS Institute, Cary, NC, USA
Pages: 12 Size: 209 Kb 
Best Presentation
tweet!  A SAS based solution for define.xml
  Monika Kawohl, Accovion GmbH, Marburg, Germany
Keywords: define.xml CDISC electronic submissions
Pages: 18 Size: 481 Kb 
tweet!  Relationships Among CDISC Variables Concerning Day and Date (CDISC Variable Relationships Part 2 of 3)
  Susan Fehrer, BioClin, Inc.; Russ Lavery
Keywords: CDISC
Pages: 10 Size: 216 Kb 
tweet!  Relationships Between CDISC Variables Linking Domains (RELREC) (Part 3 of 3)
  Susan Fehrer, BioClin, Inc.; Russ Lavery
Keywords: CDISC
Pages: 12 Size: 213 Kb 
tweet!  Creation of Submission and Analysis Data Sets by following the SDTM and ADAM requirements
  Yvane Boudraa, sanofi-aventis pharma, Antony, France
Keywords: CDISC
Pages: 4 Size: 118 Kb 
tweet!  MDMAP (Meta Data Management and Publishing) An application utilized in the management of clinical trial metadata
  Herve Guimard, Sanofi-Aventis, France; Eric Sorel, Sanofi-Aventis, France
Keywords: clinical
Pages: 5 Size: 257 Kb 
tweet!  A validated tool to create the Submission and Analysis Data Sets
  Claude Guyot, sanofi-aventis pharma, Chilly-Mazarin, France
Pages: 5 Size: 152 Kb 
tweet!  All roads lead to SDTM - which one shall we take?
  Ian Fisher, AstraZeneca, Alderley Park, UK; Meena Rahman, AstraZeneca, Alderley Park, UK; Donna Thompson, AstraZeneca, Alderley Park, UK
Keywords: CDISC
Pages: 9 Size: 58 Kb 
tweet!  Considerations for CDISC implementation
  Robert T. Stemplinger, ICON Clinical Research, Redwood City, CA; Jackie Lane, ICON Clinical Research, Redwood City, CA
Keywords: CDISC
Pages: 4 Size: 36 Kb 
tweet!  Electronic submissions - the role of the programmer
  Simon Dundas, Pfizer Global Research & Development
Pages: 8 Size: 561 Kb 

Pharmaceutical Users Software Exchange 2006   October 9-11, 2006 - Dublin, Ireland

Regulatory Affairs
Best Presentation
tweet!  Converting Data to the SDTM Standard Using SAS Data Integration Studio
  Barry Cohen, Octagon Research Solutions, Inc.
Keywords: CDISC Standards SDTM Data Integration Studio data conversion data integration
Pages: 8 Size: 332 Kb 
tweet!  Using CDISC Models for the Analysis of Safety Data
  Susan Kenny, Inspire Pharmaceuticals, Inc.; Ed Helton, SAS Institute
Keywords: CDISC SDTM ADaM safety analysis analysis datasets
Pages: 10 Size: 321 Kb 
tweet!  SAS macro validation criteria
  Jim Groeneveld, OCS Consulting
Keywords: SAS macro validation
Pages: 18 Size: 281 Kb 
tweet!  The use of CDISC Standards in SAS from Data Capture to Reporting
  Andrew Fagan, SAS; John Leveille, d-wise
Keywords: CDISC
Pages: 21 Size: 2056 Kb 

Pharmaceutical Users Software Exchange 2005   October 10-12, 2005 - Heidelberg, Germany

Regulatory Compliance, Electronic Submission & Validation
tweet!  Regulatory Compliant Validation and Deployment of SAS Programs with the Colibri Server
  Andreas Mangold, HMS Analytical Software GmbH
Pages: 7 Size: 417 Kb 
tweet!  Welcome to Dullsville!! The System Testing of SAS Macros
  James McGiffen, GlaxoSmithKline
Keywords: SAS Testing macro
Pages: 4 Size: 100 Kb 
tweet!  QualityView - a SAS program database and validation documentation tool
  Peter Gerber, Accovion; Michael Ludwig, Accovion
Keywords: validation SAS programs database
Pages: 12 Size: 825 Kb 
Best Presentation
tweet!  Understanding the Japanese culture and approval process
  Richard Harvey, AstraZeneca
Keywords: JNDA Japanese culture approval
Pages: 10 Size: 375 Kb 
tweet!  Implementing CFR 21 part 11 for SAS without tears or joins
  Dave Garbutt, BSI Business Systems Integration AG
Pages: 14 Size: 788 Kb 
tweet!  The European System for Monitoring Drug Safety, EudraVigilance
  Hans-Georg Wagner, European Medicines Agency EMEA; Olivier Simoen, European Medicines Agency EMEA
Keywords: pharmacovigilance eudravigilance EMEA
Pages: 13 Size: 678 Kb 
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