PhUSE Boston SDE - 28th September 2010
"Implementation of Standards in the Life Science Industry"
Microsoft New England R&D Center
AGENDA
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FDA Keynote
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Mat Soukup, FDA
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Conducting Statistical Reviews at FDA: Present State and Hopes of a Collaborative Future State
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Steve Wilson, FDA
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Realizing the Vision ... It's All About Standards
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Implementation of Statistical Computing Environments (SCE) Track
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Sue Dubman, Genzyme
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Metadata Driven SCE
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Wayne Woo, Novartis Vaccines
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Evolution or Revolution: Transitioning from a long history of internal standards and SAS computing environment to CDISC and an off-the-shelf SCE
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Global Data Standards Implementation
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Dimitri Kutsenko, Entimo
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Priya Gopal, Parexel
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Implementation of CDSIC standards supported by a globally distributed mapping process
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Data Integration & Tool Development
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David Schwab, Schwabtech
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Integration of data from multiple studies with divergent structures and protocols to a coherent CDISC like data base
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Matt Becker, PharmaNet
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Insights into ADaM
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Greg Silva, Biogen Idec
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From CDISC to CSR - Building tools around standards
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Panel Discussion
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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.
Click below to pay by PayPal:
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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