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"getting FDA at conference was a great addition"

GSK

 

Conference 2012

PhUSE 2012 was the eighth annual conference held at the Marriott Hotel in Budapest on 14th to 17th October and was chaired by Jean-Marc Ferran (Qualiance).

2012 Papers / Presentations

Best paper winners are highlighted in bold text and will be featured in the next edition of Pharmaceutical Programming.

Applications and Software Development  

AD01: MACUMBA - A Modern SAS GUI - Debugging Made Easy
Michael Weiss, Bayer Pharma AG
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AD02: Testing in the Cloud.  Not Just for the Birds, but Monkeys Too
Geoff Low, Medidata Solutions Inc
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AD03: Viva Usability!
Ian Fleming, d-Wise Technologies & Kristin Nienhuis, DAH Labs
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AD04: SDD ++; Extending SDD Capabilities
Daniel Christen, SAS Institute Inc
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AD05: A Maestro for Our Clinical Data... (Sanofi Clinical Data Warehouse)
Alain Vasseur, Celine Tendero & Claude Guyot  Sanofi
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AD06: SAS 9.3 Migration - A Project Experience
Jules van der Zalm & Raymond Ebben, OCS Consulting
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AD07: Using Workflows to Standardize Business Processes and Best Practices in Pharmaceutical Programming
Mark Lambrecht & Julie Maddox, SAS
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Coders Corner

CC01: Generation and Maintenance of the Data Specification Document
Melodie Bobineau & Dimitri Peteratchenko, VALVOS
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CC02: Superior gRaphics in Statistical Reports
Sameer Bamnote, Cytel Statistical Software and Services Pvt. Ltd
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CC03: Dynamically Generating Macro Innovations using SAS® Keyboard Abbreviations
Tom Van Campen & Benny Haemhouts, SGS Life Science Services
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CC04: Be Wise, Plagiarise
Karma Tarap, Novartis
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CC05: Supercharging the Proc Contents
Alain Smits, Tibotec
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CC06: Making Macros More Generic
Alain Smits, Tibotec
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CDISC & Industry Standards

CD01: ADaM Or SDTM? A Comparision of Pooling Strategies for Integrated Analyses in the Age of CDISC
Joerg Guettner, Bayer Pharma AG & Alexandru Cuza, UCB BioSciencdes GmbH
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CD02: Mapping the Company's Legacy Data Model to SDTM
Anja Feuerbacher, Nicolas Dupuis & Bruce Rogers, F. Hoffman-La Roche
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CD03: SAS® Clinical Standards Toolkit: define.xml and Value Level Metadata
Gene Lightfoot, SAS Institute Inc
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CD04: Interpreting ADaM Standards with OpenCDISC
Trupti Bal & Madhura Paranjape, Cytel Statistical Software & Services Pvt. Ltd
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CD05: Considerations for CSR Output Production from ADaM Datasets
Andrew Noller, Quintiles
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CD06: Real-World Application of the Protocol Representations Model
Joshua Pines & Michelle Marlborough, Medidata Solutions
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CD07: SDTM and AdaM: Metadata Playing Together Nicely
Kenneth Stoltzfus, Octagon Research Solutions
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CD08: Approaches to Creating ADaM Subject-Level Analysis Datasets (ADSL) for Integrated Analyses
Thomas Clinch & Nate Friemark, Theorem Clinical Research
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CD09: CDISC Advisory Board Validation Project - Best Practices for CDISC Validation Rules
Lauren Shinaberry, Business & Decision Life Sciences
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Coding Solutions

CS01:GTL (Graphics Template Language) in SAS 9.2
Philip R Holland (Holland Numerics)
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CS02: Parsing ISO 8601 Standard Partial Dates using Perl Regular Expressions
Mark Crangle, ICON
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CS03: Grouped Jittered Boxplots in SAS 9.2 and SAS 9.3
Volker Harm & Catalina Mejia Herrera, Bayer Pharma AG
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CS04: JMP Clinical® 4.0
Valerie Nedbal, SAS Institute
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CS05: Reprogramming a Many-to-Many Merge with Hash Objects
David Garbutt, Freelance
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Data Handling

DH01:Pooling Clinical Data: Key Points and Pitfalls
Florence Buchheitt, Novartis
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DH02: Measure the Benefit of Standards Ltd - Provide Evidence to the Gut Feeling
Gary Fleming, Roche Products Ltd
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DH03: Optimizing Data Validation
Andrew Newbigging, Medidata Solutions
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DH04: Controlling Controlled Terminology
Ryan Burns, Rho Inc
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DH05: Improving Data Management with Systems Integration and Next Generation Data Flow
Richard Davies, Oracle
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DH06: The Italian Post-Marketing Registries
Entela Xoxi, Italian Medicines Agency
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DH07: Using Metadata to Integrate and Standardise Clinical Trial Data - the ICON Study Data Mapper
Paul Crean & Jennie McGuirk, ICON Clinical Research
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DH08: Legacy Data Conversion: A Journey of Discovery
Panteleo Nacci, Novartis Vaccines & Diagnostics Srl
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Health Outcomes Research and Epidemiology

HE01: Skills for SAS Programmers in Epidemiology
Philip Holland, Holland Numerics Ltd
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HE02: Programming Challenges of Sampling Controls to Cases from the Dynamic Risk Sets in Nested Case Control Studies
Victor Kiri, FV & JK Consulting Ltd
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HE03: The Logic and Logistics of Logistic Regression, Including New Features in SAS® 9.2
Lawrence Rasouliyan, ICON
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HE04: Designing Co-Medication Matrices Using a Burt Table Principal
Berber Snoejer, Pharmo Institute
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HE05: Validation in Epidemiological Studies
Raimund Storb, UCB BioSciences, GbmH
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HE06: Novel Programming Methods for Working with Large Claims Databases
Richard Allen, Peak Statistical Services
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HE07: Bootstrap Analysis Double-Independent Programming: Issues and Solutions
Nils Penard, UCB BioSciences, GmbH
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Industry Starters

IS01: The Logic of a Programmer - A Case Study
Julie Oates, Quanticate
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IS02: Changing SAS Discipline into the Life Science Sector
Chris Gibby, OCS Consulting
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IS03: The Power of PROC SQL
Amanda Reilly, ICON
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IS04: An Introduction to SDTM, 298 Pages in 20 Minutes?
Jennie McGuirk, ICON
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IS05: A Peak at PK - An Introduction to Pharmacokinetics
Hannah Twittchet & Paul Grimsey, Roche
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IS06: What Makes Oncology Special?
Johanna Mursic, Novartis
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IS07: iTeam: Having a Voice of Opinion
Mijanur Rahman, Roche
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Management (No Papers/Presentations available)

MA01: The Departmental Crossroads
Stephen Bamford, Cerafor

MA02: Getting the Right Sourcing Mix Prepares Statistical Programming for the Big Data Explosion
Ed Jones, Genentech Inc

MA03: How to Forge Successful Partnerships with Low Cost Regions
Elisa Fatziner, Cmed & Simon Wilcock, ICON

MA04: Recruitment Challenges in the Industry
Andy York, Shire Pharmaceuticals & Frances Wells, Pharmanet/i3

MA05: The Era of TLG is (almost) Over!!!
Olivier Leconte, Hoffman-La Roche

MA06: The Role of PhUSE

Professional Development & Training

PD01: Create Innovation Now!
Colin Brown, Roche
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PD02: Two Tins and a Piece of String
Diana Stuart, Cmed
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PD03: The 3 Year Obsession: Length of Experiences the Sole Determinant of Competence?
Meghana Bhagwat & Manjusha Gode, Cytel Statistical Software and Services Ltd
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PD04: New Era for Data Management - Redfine Collaboration
Michaela Jahn, Roche
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PD05: How Specifications Get Lost in Translation
Ralf Minkenberg, Boehringer Ingelheim Pharmaceuticals
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PD06: Process Simplification - The Simple Way!
Neeraj Malhotra, Roche
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PD07: Are We Really So Busy?
James Gallagher, Roche
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Poster Presentations

PP01: Validation CDISC Data with the SAS Clinical Standards Toolkit
Nicolai Hagg, HMS Analytical Software
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PP02: Simplifying SAS Clinical Standards Toolkit - Where's the Easy Button?
Gene Lightfoot, SAS Institute Inc
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PP03: Programming by Rules
Magnus Mengelbier, Limelogic Ltd
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PP04: Validation to define.xml
Sam Tomioka & Steven Huang, Sunovion
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PP05: Centralised Risk-Based Source Data Verification
Shafi Chowdhury, Shafi Consultancy
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PP06: ADaM in a Pool! A Concept on how to Create Integrated ADaM Datasets
Alexandru Cuza, UCB BioSciences GbmH
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PP07: Integrating Clinical Images into the Data Review Process - One Tool to Visualize Clinical Images and Associated Clinical Data
Kellie Riley, Roche Products Ltd
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PP08: Which Programs use that Dataset?
Helen Nicholson, Cmed
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PP09: Using a Free Synax - Coloured SAS Log Viewer to Bookmark Important Messages, Filter them and More!
Julien Vanswinsberghe & Francois Vandenhende, ClinBAY
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PP10: Medical Data Review and Exploratory Data Analysis using Data Visualization
Vinod Kerai, Roche Products Ltd
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PP11: A Tool to Catalogue Statistical Outputs Developed for Submission by Linking Two in-house systems
Katja Diezel, Novartis
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PP12: SAS Macro Package to Automate Coding Graphics
Philippe Remusat, ClinBAY
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PP14: Risk-Benefit Analysis for Oncology Clinical Trials
Lovemore Gakava, Waseem Jugon, Dominic Littish & Jayantha Ratnayake, Roche Products Ltd
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PP15: Metaprogramming in SAS
Arvind Chaudhari, Cytel Statistical Software & Services Pvt. Ltd
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PP16: Quartiles within SAS
Jorine Putter & Liz Faber, Quanticate
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PP17: Off Shored, 5 Years On
Bhupendra Mistry, Roche Products Ltd
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PP18: Tricks for Testing Standard Macro Components in SAS Software
Lina Ulkjaer Jorgensen, Novo Nordisk
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PP19: Macro to Replace Missing Values
Mokhfur Alam Chowdhury & Kamrunnisa Runu, Shafi Consultancy
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PP20: Using the Latest ODS Features in SAS 9.2
Chris Gibby, OCS Consulting & Kevin Scase, NOTOX
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PP21: One Approach to a Metadata and Data Standards Repository
Bill Gibson, SAS
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PP22: Understanding SAS...the SAS-sy Way!
Amar Nayak, Synergy
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PP23: Study Protocol Flexibility vs Programming Standard Rigidity
Samia Kabi, Novartis
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PP24: Controlling Controlled Terminology
Ryan Burns, Rho
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PP25: Enhancing Research Through Clinical Data Standardisation
Pankaj Bhardwaj, Tata Consultancy Services
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PP26: Stress, Tips and Tricks
Colin Brown, Roche Products Ltd
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Regulations in the Healthcare Industry

RG01: New Approaches to Validation for SaaS-based Clinical Computing Solutions in the Cloud
Tony Hewer, Medidata Solutions Inc
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RG02: To EC or Not EC...that is the Question!
Hiren Naygandhi, Roche
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RG03: Cost Effective Standards Implementation: A New Paradigm for the Drug Development Life Cycle
Jeff Abolafio, Rho & Frank Dilorio, CodeCrafters Inc
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RG04: Centralised Risk-based Source Data Verification
Shafi Chowdhury & Mokhfur Chowdhury, Shafi Consultancy
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RG05: "Bertha.sas" - User Friendly Ways to get Traceability
Elena Glathe. Bayer Pharma AG
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RG06: Spotting DILI for FDA Submission
Nicola Tambascia & Sven Greiner, Accovion
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Software Development

SD01: East6: Software for Designing, Simulating and Monitoring Group Sequential Trials
Hrishikesh Kulkarni & Sheetal Solanki, Cytel Software & Services Pvt. Ltd
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SD02: Reveal: Web-Based Software for the Unique Challenges of Enterprise Clinical Data Search
Jon Davidson, d-Wise Technologies UK Ltd
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SD03: Define.xml for ADaM: From Results to SDTM
Dimitri Kutsenko, Entimo AG
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SD04: SAS Drug Development 4.1 - Clinical Programming and Workflow
Mark Weadon & Mark Lambrecht, SAS Institute
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SD05: Clinical Reference Library: Metadata and Standards Management in a Single Tool
Jonathan Peachey, Colin Sprink & Bryan Munday, IBM
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SD06: Master Data Management and Possible Applications for Clinical Trial Data
Bill Gibson, SAS
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Statistics and Pharmacokinetics

SP01:A Supplement to the SAS Survival Guide- Nonparametric Regression
Karl-Ernst Siegler, CRS-Clinical Research Services
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SP02: Misinterpretation of Statistics - An Introduction
John Salter, Cerafor
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SPO3: Bootstrap Simulations to Estimate Overall Survival Based on the Distribution of a Historical Control
Antonio Nieto & Javier Gomez, PharMar
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SP04: Training Statistical Programmers on SAP Review Skills
Sascha Ahrweiler, UCB BioSciences GmbH
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SP05: Time Series Modeling of Vaccine Efficiency Using JMP Add-in
Robert Eric Huisden, OCS Biometric Support
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SP06: Quartiles within SAS Procedures
Jorine Putter & Liz Faber, Quanticate
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SP07: Multicollinearity Diagnostics in Statistical Modeling and Remedies to Deal with it Using SAS
Harshada Joshi & Swapna Deshpande, Cytel Statistical Software & Services Pvt. Ltd
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SP08: Estimating Terminal Half Life by Non-Compartmental Methods with Some Data Below the Limit of Quantification
Jochen Mueller-Cohrs, CSL Behring GmbH
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Technical Solutions

TS01: SAS Clinical Standards Toolkit 1.5 - How Do I Know My Metadata is Right?
Gene Lightfoot, SAS Institute Inc
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TS02: A Simple Interface for Meta-Data
Magnus Mengelbier, Limelogic Limited
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TS03: A Macro to Replace PROC PEPORT!?
Katja Glass, Bayer Pharma AG
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TS04: Let SAS Handle your CDISC Compliance Check: Automating OpenCDISC Validator in SAS
Edwin van Stein, Chiltern International BV
Best Wiki
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TS05: Controlling OpenCDISC Using R
Martin Gregory, Merck Serono
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TS06: Deep Dive into ODM Validation
Ronald Steinhau, Entimo AG
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TS07: A Long Way Down from an Output-Window to the Bottom of PDF - Some Shortcuts
Karl-Ernst Siegler, CRS-Clinical Research Services
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