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  PhUSE Boston SDE - 28th September 2010

"Implementation of Standards in the Life Science Industry"

Microsoft New England R&D Center

AGENDA

FDA Keynote

Mat Soukup, FDA

Conducting Statistical Reviews at FDA: Present State and Hopes of a Collaborative Future State

Steve Wilson, FDA

Realizing the Vision ... It's All About Standards  

Implementation of Statistical Computing Environments (SCE) Track

Sue Dubman, Genzyme

Metadata Driven SCE

Wayne Woo, Novartis Vaccines

Evolution or Revolution: Transitioning from a long history of internal standards and SAS computing environment to CDISC and an off-the-shelf SCE  

Global Data Standards Implementation

Dimitri Kutsenko, Entimo and

Priya Gopal, Parexel  

Implementation of CDSIC standards supported by a globally distributed mapping process  

Data Integration & Tool Development

David Schwab, Schwabtech

Integration of data from multiple studies with divergent structures and protocols to a coherent CDISC like data base

Matt Becker, PharmaNet Insights into ADaM

Greg Silva, Biogen Idec

From CDISC to CSR - Building tools around standards  

Panel Discussion

Future of Standards and New Trends in their Implementation


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We are excited to host the first US based PhUSE Single Day Event (SDE).  Click here to register today. The 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?
- Statistical Programmers
- Statistical Programming Management
- Biostatisticians
- eClinical Professionals

At the end of this conference 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.

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This event has been sponsored by:


Lunch sponsor:

 

                                                                               

If you need any further information or assistance, please contact office@phuse.eu.

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