Foster City, CA
22nd February 2018
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Registrations per company are limited to 20% of maximum attendance.
Marching at the Double-quick to Successful Submissions with Innovative Automation within the Study Life Cycle
In the past ten years, new standards have affected the entire drug development lifecycle from data collection through to regulatory submission. Developed by CDISC, ICH, NCI, HL7, W3C, ISO and even the FDA, they have the potential to support more seamless interoperability and process automation. It’s up to us in the industry to make that potential a reality through the effective use of standards by the software and processes we develop and use.
Looking ahead, new standards and processes will integrate new sources of data, such as automated biometric data capture and next-generation genomics data, into the familiar world of clinical data collection and analysis. These new data types are key to developing the next generation of precision pharmaceuticals. The standards to support them will emerge from industry and ultimately find their way into the standards catalogues of regulatory agencies.
This event will focus on practical ways in which the industry can respond to the challenges of improving efficiency and integrating new data sources. We’ll hear about case studies in process improvement that accelerated time to successful submissions, and about software tools and techniques to integrate new data types and enable process efficiencies.
Foster City Community Center 1000 E. Hillsdale Boulevard - Wind Room
Foster City, CA
|8.30 - 9.15
|9.15 - 9.30
||Welcome & Introduction to Keynote
Iris Statistical Computing
|9.30 - 10.00
||Accelerating Consistent and Quality Nonclinical SEND Study Submissions with Automation and Machine Learning
||Suresh Madhavan &
|10.00 - 10.30
||Raising the Bar for Data Standardization: How to Ensure Your Submission Supports the Automated Review Process at FDA and PMDA?
|10.30 - 11.00
|| Morning Break
|11.00 - 11.45
||Have Data Standards – Now What? Next Steps Required to Put Them to Work to Fuel the Furnace of Data Innovation
|11.45 - 12.00
||Selecting a Method for Creation of First Define-XML
||Paul Hamilton &
|12.00 - 13.00
|13.00 - 13.15
||PhUSE Update and Working Group Introduction
PhUSE Americas Director
|13.15 - 13.45
||Automatically Generate Define-XML from Clinical Trials Data as RDF with SPARQL Query
|13.45 - 14.15
||Multimodal Drug Safety
|14.15 - 14.45
|14.45 - 15.30
||Building Quality and Efficiency into Biometrics Tools and Processes
||Linda Collins &
|15.30 - 16.00
||Panel Discussion and Closing Remarks
Catering and refreshments will be provided throughout the day.
Lisa Brooks, Iris Statistical Computing
Kunaal Madhavan, PointCross
If you have any questions, or require any information, please contact the SDE Co-Chair.
If you are interested in sponsoring this event, click here.
Courtyard by Marriott San Mateo Foster City
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