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"interesting to hear views on the subject"

AstraZeneca

Conference 2005

The inaugural PhUSE conference was held in October 2005 in the beautiful city of Heidelberg, Germany. It was a great success, with over 270 delegates able to attend a full program of 60 presentations across 11 streams, with 25 posters also on display.

Following the opening speeches from Stephen Bamford (PhUSE Chairman) and Allan Russell (SAS) on Monday morning, 3 parallel sessions were run in the historical Stadthalle building throughout the rest of the conference. In addition to this delegates could visit the exhibition and demonstrations areas, and view the posters.

Highlights of the first day were the "Applications and Software Development" stream which ran throughout the day in the Grand Hall, the ever popular "Coder's Corner" stream and the "Regulatory Compliance, Electronic Submission and Validation" stream.

The Monday evening saw the main mixer session that consisted of a cocktail reception and "Cuban style" buffet. This was very well attended and gave everyone the opportunity to mingle and discuss the events of the day, long into the night.

The CDISC panel discussion

The second day started bright and early with the beginning of the "CDISC and XML" stream. Over the next day and half all aspects of CDISC implementation were covered in 13 presentations, including 2 from Dr. Rebecca Kush, founder and president of CDISC. The "Technical Solutions" stream also ran throughout the second day, primarily focussing on the use of ODS within the reporting process. Last but not least the "Statistics and PK" and "Professional Development" streams offered alternative viewing. Tuesday ended with an opportunity to discuss poster contents with the authors in the manned session.

Wednesday morning saw the conclusion of the "CDISC and XML" and "Application and Software Development" streams. Following this was a CDISC panel discussion, which ended with a lively and interesting debate on the future of Health Authority submissions in a CDISC world.

2005 Papers

Best paper winners are highlighted in bold text.

Applications and Software Development

AS01: Rich, Handsome & Successful: The Power of SAS to the Scientists and Statisticians in Research
David Shannon, Amadeus (Size: 458 Kb)

AS02: The HAWK has a good (SAS) view
Olivier Leconte, Servier (Size: 285 Kb)

AS03: Visions of a drug development data warehouse
Paul Vervuren, Organon (Size: 403 Kb)

AS04: Macro MDU: a flowchart of used programs, datasets and TLF's based upon the Final Run
Herman Ament, Organon (Size: 207 Kb)

AS05: Design Principles & Implementation of a Reporting System
Anup Patel, GlaxoSmithKline & Lee Seymour, GlaxoSmithKline (Size: 123 Kb)

AS07: Analysis of Pharmacokinetic data : using SAS to create an autonomous environment for the Phamacokineticist
Steve Prust, Covance CRU (Size: 53 Kb)

AS08: SAS/AF and Software Prototyping - Having your PIE and eating it!
Edward Foster, Oxford Pharmaceutical Sciences (Size: 293 Kb)

AS09: Implementing CFR 21 part 11 for SAS without tears or joins
Dave Garbutt, BSI Business Systems Integration AG (Size: 788 Kb)

AS11: Using VBA and BASE SAS to Get Data from SAS to Excel Without Data Integrity Issues
Timothy Adlington, AstraZeneca (Size: 65 Kb)

AS12: Migration of a flexible reporting system from SAS 6.12 to SAS 9.1.3 - A project experience
Raymond Ebben, OCS Consulting (Size: 951 Kb)

AS13: Designing a Global SAS9 Architecture for Clinical Trials Analysis and Reporting
Greg Nelson, ThotWave Technologies & Andrew York, Covance (Size: 67 Kb) 

AS14: A Sample Web-Based Reporting Container for ODS XML Reports
Chris Olinger, d-Wise Technologies, Raleigh, NC (Size: 76 Kb)

AS15: Integrating SAS With Open Software in a Validated Drug Safety Environment
Jeremy Fletcher, Roche (Size: 671 Kb)

Coder's Corner

CC01: Sort your SAS Graphs and Create a Bookmarked PDF Document Using ODS PDF
Dirk Spruck, Accovion GmbH & Monika Kawohl, Accovion GmbH (Size: 133 Kb)

CC03: SAS to R to SAS
Philip R Holland, Holland Numerics Ltd (Size: 256 Kb)

CC04: Implementing shared column variables
Shan Lee, GlaxoSmithKline (Size: 175 Kb)

CC05: Automatically Right-Size Every Character Column after Importing Your Data to SAS: From the 255-byte Default to the Real Requirements
LeRoy Bessler, Assurant Health (Size: 18 Kb)

CC06: Empty lines in SAS tables (list output and ODS RTF) produced by Proc Tabulate
Twan van Berkel, NV Organon (Size: 229 kb)

CC07: PROC REPORT with the flexibility of an unspecified number of treatment or reporting columns
Magnus Mengelbier, Independent Consultant (Size: TBA Kb)

CC09: Signal Detection in EudraVigilance
Jim Slattery, European Medicines Agency EMEA (Size: 42 Kb)

CDISC and XML

CD01: An Introduction to CDISC - What is CDISC and Why Standards?
Laurie Rose, SAS Institute & Becky Kush, CDISC (Size: 1223)

CD02: An Introduction to CDISC - Available CDISC Standards and Models
Laurie Rose, SAS Institute (Size: 1612 Kb)

CD03: An Introduction to CDISC - CDISC Collaborations and Standards in Progress
Becky Kush, CDISC (Size: 1531 Kb)

CD04: Best Practices for Managing Clinical Research Information
Dave Handlesman, SAS Institute (Size: 1490 Kb)

CD05: Pharmacovigilance Using SAS Technology , Analytics and CDISC Data Standards, including the SDTM-ADaM Submission Relationship
Ed Helton, SAS Institute (Size: 1498 Kb)

CD06: What SAS is doing for the FDA's Critical Path Initiative?
Andrew Fagen, SAS Institute (Size: 557 Kb)

CD07: ODM & define.xml
Dave Iberson-Hurst, Assero Limited (Size: 924 Kb)

CD08: SAS Dataset Content Conversion to CDISC Data Standards
Tony Friebel, SAS Institute (Size: 270 Kb)

CD09: Software Tools for working with CDISC ODM, SDTM, LAB and define.xml
Jozef Aerts, XML4Pharma (Size: 33 Kb)

CD10: Customer oriented CDISC implementation
Edelbert Arnold, Accovion GmbH & Ulrike Plank, Accovion GmbH (Size: 233 Kb)

CD11: Mapping Corporate Data Standards to the CDISC Model
David Parker, Astra Zeneca (Size: 296 Kb)

CD13: The Future of CDISC
Becky Kush, CDISC (Size: 1046 Kb)

CD14: CDISC Activities in Europe
Udo Siegmann, Parexel International (Size: 310 Kb)

Data Management

DM01: Consistent Variables + Consistent Checks = Cleaner Data
Greg Silva, Biogen Idec Ltd (Size: 156 Kb)

DM03: Managing Clinical Trials Data using SAS
Martin Rosenberg, MAJARO InfoSystems (Size: 1530 Kb)

DM04:  Data Mining in a pharmaceutical environment
Franky De Cooman, Business & Decision (Size: 19 Kb)

DM05: Complex Laboratory Data, Strategies and Tools for a Way out of the Maze
Benjamin Szilagyi, Novartis & Christof Binder, BIOP AG (Size: 167 Kb)

DM06: You don't need second sight to use the LIBNAME ORACLE
Olivier Leconte, Servier (Size: 137 Kb)

Professional Development & Management

PD02: Tactical Recruitment of SAS Programmers: Wisdom or Foley?
Katherine Hutchinson, Oxford Pharmaceutical Sciences (Size: 121 Kb)

PD03:  Effective Presentations: Remembering Your Audience
Greg Nelson, Thotwave Technologies & Neil Howard, Independent Consultant (Size: N/A)

PD05: Kisses, Nakedness and Love - What makes a good Clinical Trials Programmer??
Josephine Duvoid, Independent consultant (Size: 130 Kb)

Statistics & Pharmacokinetics

PK01: Power calculation of non-inferiority trials assuming poison distributions
Corinna Miede, Accovion & Jochen Muller-Cohrs, Accovion (Size: 228 Kb)

PK02: A Practical Introduction to the Bootstrap Using the SAS System
Nancy Barker, Oxford Pharmaceutical Sciences (Size: 97 Kb)

PK03: Splendida fugilente oculi, e.g. dummy randomization lists to more than designed patient profiles
Magnus Mengelbier, Amgen (Size: 170 Kb)

PK06: A case study to demonstrate the recommended approach from NICE to assess uncertainty in cost effectiveness models
Karen Ooms, Statwood (Size: 9 Kb)

Posters

PS01: Harmonised PK Analysis & Reporting
Ian Barretto, GlaxoSmithKline (Size: 749 Kb)

PS02:  SAS Certification: is it for you?
Sarbjit Rai, Genentech (Size: 214 Kb)

PS03: An Introduction to ODS
Neville Cope, Amgen (Size: 311 Kb)

PS04: Automatic Parameter Checking
Greg Silva, Biogen Idec Ltd (Size: 872 Kb)

PS05: Easy, Elegant, and Effective SAS Graphs: Inform and Influence with Your Data
LeRoy Bessler, Assurant Health (Size: 656 Kb)

PS06: How can you make the entire clinical trial process easy and fun for the users and also reduce your costs?
Carl-Olow Magnusson, SAS Institute & Ann-Sofie Bergstrom, SAS Institute (Size: 99 Kb)

PS07: Sort your SAS Graphs and Create a Bookmarked PDF Document Using ODS PDF
Dirk Spruck, Accovion GmbH & Monika Kawohl, Accovion (Size: 142 Kb)

PS08: Implementing shared column variables
Shan Lee, GlaxoSmithKline (Size: 77 Kb)

PS10: Empty lines in SAS tables (list output and ODS RTF) produced by Proc Tabulate
Twan van Berkel, NV Organon (Size: 390 Kb)

PS14: The Dataset Diet - How to transform short and fat into long and thin
Kathryn Wright, Oxford Pharmaceutical Sciences (Size: 328 Kb)

PS16: Customer oriented CDISC implementation
Edelbert Arnold, Accovion & Ulrike Plank, Accovion (Size: 453 Kb)

PS18: Effective communication with colour
LeRoy Bessler, Assurant Health (Size: 688 Kb)

PS21: CLIREV - A friendly and flexible Clinical Data Review Tool
Angelo Tinazzi, SENDO Tech S.r.l. (Size: 615 Kb)

PS22: New functions in SAS9
Ian Amaranayaka, Amadeus (Size: 157 Kb)

PS23: Analysis of Pharmacokinetic data: using SAS to create an autonomous environment for the Phamacokineticist
Steve Prust, Covance CRU (Size: 121 Kb)

PS24: Visions of a drug development data warehouse
Paul Vervuren, Organon (Size: 2859 Kb)

PS25: SAS/AF and Software Prototyping - Having your PIE and eating it!
Edward Foster, Oxford Pharmaceutical Sciences (Size: 330 Kb)

PS26: Using VBA and BASE SAS to Get Data from SAS to Excel Without Data Integrity Issues
Timothy Adlington, AstraZeneca (Size: 395 Kb)

PS27: Understanding what 'make' can do for you
Dave Garbutt, BSI Business Systems Integration AG (Size: 532 Kb)

Regulatory Compliance, Electronic Submission & Validation

RC01: Regulatory Compliant Validation and Deployment of SAS Programs with the Colibri Server
Andreas Mangold, HMS Analytical Software GmbH (Size: 417 Kb)

RC02: Welcome to Dullsville!! The System Testing of SAS Macros
James McGiffen, GlaxoSmithKline (Size: 100 Kb)

RC03: QualityView - a SAS program database and validation documentation tool
Peter Gerber, Accovion & Michael Ludwig, Accovion (Size: 825 Kb)

RC04: Understanding the Japanese culture and approval process
Richard Harvey, AstraZeneca (Size: 375 Kb)

RC05: Implementing CFR 21 part 11 for SAS without tears or joins
Dave Garbutt, BSI Business Systems Integration AG (Size: 788 Kb)

RC07: The European System for Monitoring Drug Safety, EudraVigilance
Hans-Georg Wagner, European Medicines Agency EMEA & Olivier Simoen, European Medicines Agency EMEA (Size: 678 Kb)

SAS Starters

SS02: It's Proc Tabulate Jim, but not as we know it!
Rob Walls, PPD (Size: 281 Kb)

SS03: Using ODS RTF with Style
Rob Walls, PPD (Size: 386 Kb)

Technical Solutions

TS01: To ODS RTF & Beyond, Third Edition
David Shannon, Amadeus Software (Size: 331 Kb)

TS02: A SAS-based solution to perform a documented selective copy of files on Microsoft Windows platform
Frederic Coppin, Merck Sharp & Dhome & Carl Herremans, Merck Sharp & Dhome (Size: 283 Kb)

TS03: Pagination in the ODS
John Kirkpatrick, Insight Statistical Consulting Ltd (Size: 118 Kb)

TS04: Only interactive graphics will do
Nelson Kinnersley, Roche Products Ltd (Size: 188 Kb)

TS05: Getting Started with, and Getting the Most out of, SAS ODS PDF: No Mastery of PROC TEMPLATE Required
LeRoy Bessler, Assurant Health (Size: 1874 Kb)

TS06: Experiences of using ODS : moving from ASCII to RTF output
Steve Prust, Covance CRU (Size: 249 Kb)

TS07: Opportunities for efficiency created by the ODS
John Kirkpatrick, Insight Statistical Consulting Ltd (Size: 165 Kb)

TS08: Automatic Parameter Checking
Greg Silva, Biogen Idec Ltd (Size: 158 Kb)

TS09: The SAS Data step/Macro Interface
Lawrence Heaton-Wright (Size: 65 Kb)

TS10: Technical application of ETL Studio in the clinical reporting process
Dave Smith, SAS Institute (Size: 248 Kb)

Tutorials

TU03: Using tagsets to provide customised output: A tutorial
John Kirkpatrick, Insight Statistical Consulting Ltd (Size: 225 Kb)

TU04: SAS-with-Excel Application Development: Tools and Techniques
LeRoy Bessler, Assurant Health (Size: 1373 Kb)

TU05: The FORMAT procedure - more than just a VALUE statement
Lawrence Heaton-Wright, Quintiles (Size: 67 Kb)

TU06: The Dataset Diet - How to transform short and fat into long and thin
Kathryn Wright, Oxford Pharmaceutical Sciences (Size: 151 Kb)

TU07: Easy, Elegant, and Effective SAS Graphs: Inform and Influence with Your Data
LeRoy Bessler, Assurant Health (Size: 655 Kb)

TU08: Macro Design & Development by Example
Dante diTommaso, Novartis (Size: 223 Kb)

TU09: The Developing Role of XML
David Shannon, Amadeus (Size: 252 Kb)