Section

Description

Chair

Co-chair

Applications and Software Development

AD

Applications and Software Development papers focus on the use of software in the development of applications, including those utilising SAS or S-Plus but also Java, Perl and .NET. Presentations in this section cover the application's code and development process - development, implementation and integration in the company's environment and processes. Papers can include any "lessons learned" or "suggestions for future development".

Jean-Marc Ferran

Pierre Mayeur 

Coder’s Corner

CC

The Coder's Corner section is dedicated to brief presentations of real-life code, programming tips, efficiency techniques, undocumented features, useful algorithms and macros and other creative uses of software.

Jules van der Zalm

Berber Snoeijer

Coding Standards

CS

Coding Solutions papers concentrate on validated and documented single scripts or macros; not coding language specific.  Solutions presented will cover different programming needs; complex algorithms, standardization and/or solving recurrent issues.

Alain Vasseur

Anne Mounier-Langlo

DH

The Data Handling stream is dedicated to many aspects of data handling and database management done by programmers in the pharmaceutical industry, e.g. management of data and data flow, metadata, extracting raw data from various sources, data validation, data acceptance, data transformation and the interfaces to clinical data management systems.

Professional Development & Training

PD

Development & Training session cover training and certification, hiring and managing Programmers as well as career development.  This year we will focus specifically on Project management and Skills Training that help us produce our deliverables faster.

Jennie McGuirk

Tangi  Sanseau

Posters

PO

Posters cover a wide variety of topics in a poster board form rather than a formal lecture. Posters are ideal for presentations that include graphics, source code, statistical concepts or thought-provoking concepts that invite conference participants to review at their own pace. Posters are on display throughout the conference and authors are available for questions during a designated time.

Kathryn Wright

Alison McDonald

CDISC & Industry Standards

CD

The CDISC organisation has established standards to support the acquisition, exchange, submission and archival of clinical data and metadata.  This stream focuses on the
a) Development of these tools
b) Processes to implement these data standards
c) e-Submissions and interactions with the health authorities.

Frans Wald

Michael Knoessl

Regulatory

RG

This stream focuses on all aspects of interactions between statisticians/programmers and health authorities (not just the FDA). Topics covered may include, but are not limited to: Validation of programs, Inspections and audits, Regulations: 21 CFR part 11, GCP, ICH, etc.

Stephen Harrison

Beate Hientzsch

University Day

UD

The objective of the PhUSE University day is to allow industry professionals and representatives from academia (staff and students) to share their different views and perspectives on the use of software within analysis and reporting of clinical data. We hope that there will be a good mix of useful information via formal presentations and lively discussion and that the experience will inspire students to potentially consider a programming career within the area of Health and Life Sciences in the future.

Dave Barrett

James Bidwell

Statistics & Pharmacokinetics

SP

The Statistics and Pharmacokinetics section is designed to allow users to share how they have used any statistical or computing package to resolve statistical issues within the clinical trial field.

Fritz Schindel

Martin Gregory

Technical Solutions

TS

Technical Solutions papers concentrate on innovative solutions that enable us to problem solve, analyse and present data and develop systems.  These papers are not limited to SAS and can cover a wide range of technologies and interfaces.

Ian Amaranayake

Mike Needham

Tutorials

TU

In the Tutorials section experienced users will provide in-depth explanations of a wide range of topics. All presentations are denoted as Beginning, Intermediate and Advanced for users at all levels of expertise.

Dominique Pinet

Antoine Brisacier

Management

MA

The Management Stream is designed to provoke discussions surrounding contemporary challenges met by the Programming Managerial community. The format of the stream will be an invited presenter presenting a topic and then the audience is invited to openly discuss this topic. The audience is open to all PhUSE participants.

Louise Webber

Roy Ward