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"In a clear presentation it gave a perfect insight into our struggle with SDTM and legacy data"


  PhUSE Boston SDE - September 28th 2010

"Implementation of Standards in the Life Science Industry"

Microsoft New England R&D Center

***** SOLD OUT *****


Introduction and Welcome
Dan Boisvert/
Chris Decker
FDA Perspective: The Future of Standards
Mat Soukup/
Steve Wilson
Morning Break

10.50-12.00 noon
Implementation of CDISC Standards Supported by a Global Process
Dimitri Kutsenko/
Priya Gopal
Future of Standards and New Trends in Implementation
Sally Cassells/
Max Kanevsky/
Dave Handelsman/
Steve Wilson/
Rohit Dhanjal
Lunch - sponsored by SAS

The Potential of Statistics Computing Environments within Standards Implementation
Sue Dubman/
Wayne Woo
Afternoon Break

Experiences in Data Integration, Tool Development and Analysis Data
Greg Silva/
David Schwab/
Matt Becker
Wrap Up
Dan Boisvert/
Michael Whitworth

This event is now sold out. PhUSE has had a record number of registrations.
Look out for our 2011 USA Single Day Events.

We are excited to host the first US based PhUSE Single Day Event (SDE). Cost for membership for US members is $30 and comes with a free 2010 membership.  A Single Day Event allows attendees a chance to intimately interact with the leaders of industry and network with colleagues.  While most conferences concentrate on the speakers, at PhUSE the concentration is on the conversation the presentation evokes.  Ample time is given for questions and discussion.  The event is free to society members.

The PhUSE SDE Boston will concentrate on the "Implementation of Standards in the Life Science Industry".  We have gathered an array of excellent speakers to guide us through the tangled web that is standard implementation.  Our interpretation of standards implementation reaches beyond data standards (CDISC) to include clinical data analysis standards.  This includes both the use of new technologies and processes used to help accelerate and ameliorate clinical data analysis.  Talks will be given by regulators, Biotech, Pharma, CRO and Technology company representatives.  The day will kick off with two presentations by FDA Statistical Reviewers.

Dr Stephen Wilson, Director of the Division of Biometrics III at CDER and Dr Mat Soukup, Acting Team Lead for the Safety Division with the Office of Biostatistics at CDER - both have been exemplary advocates of industry wide standards implementation adoption and collaboration.  The day will continue with talks on Statistical Computing Environments, Data Integration and Company side Data Standards' Adoption

Who should attend this event?

Professionals involved in the handling of Clinical Data, information and knowledge including:


  • Managers within the life science industry dealing with standardization of data.
  • Programmers
  • Data Managers
  • Statisticians

attendees will:
- Understand the view point of statistical reviewers on standards and their implementation
- Understand practical strategies for standards implementation
- Be introduced to new technologies and how they apply to statistical programmers
- Learn from other companies experiences

Directions to the Microsoft New England R&D Center can be found here.  Recommended hotels nearby can be found here.

This event has been sponsored by:

Lunch sponsor:



If you need any further information or assistance, please contact

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