Boston, MA, USA

Optimizing the Use of Data Standards for eSubmission




On April 27, 2017 we continued our year of celebration for our 100th PHUSE Single Day Event (SDE) at Shire, in Lexington, MA. Our theme for this SDEs was “Optimizing the Use of Data Standards for eSubmission”, which attracted over 100 registrants from various Biopharmaceutical and CRO companies in the greater Boston area. The venue was a very nice conference center with plenty of room for the event.  The presentations were excellent, the food was great, and we were a bit flexible with the schedule which provided for plenty of networking opportunities.  With thanks to our volunteers, sponsors and attendees, we can chalk this one up as another great event in the Boston area! 



PHUSE Updates – Chris Hurley, PHUSE US Director

Standards Governance and Implementation in a Time of Rapid Change – Diane Piper & Karin LaPann, Shire Pharamaceuticals

A Moratorium on the Standards Madness – Scott Bahlavooni, d-Wise

A Need for Good Data-validation Practice – Max Kanevsky, Pinnacle 21

Protocol Representation: The Forgotten CDISC Model – Frank Dilorio, CodeCraters

Optimizing the Use of Data Standards for eSubmission – Jennifer Feldmann, Instem

eCTD Technical Validation of SDTM and SEND Data – Crystal Allard, FDA

Roadmap for Managing Multiple CRO Vendors – Veena Nataraj, Shire Pharmaceuticals

Think Data! Think CDISC! Think Submission! – Bhavin Busa & Kishore Pothuri, Vita Data Sciences

Challenges and Best Practices for New FDA Nonclinical Trial Submissions – Jacquice Davis, PointCross Life Sciences

Common Misconceptions when Implementing SDTM – Jerry Salyers, Accenture

A Data-driven Approach for Generating Define-XML v2.0 Using ADaM Specifications and ADaM Datasets – Hima Bhatia, ICON


Download the event brochure.


SDE Chairs:

Gary Chen, Pfizer.

Nand Kishore Rawat, Cytel.

If you have any questions, or require any information, please contact the SDE Co-Chair.









Photos of the Day:


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