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"interesting to hear views on the subject"


2015 PhUSE CSS
March 15th - 17th

The Annual Computational Science Symposium brings together Academia, Regulators, Industry and technology providers to address computational science needs in support of regulatory review and ultimately bring safe and effective products to those who need them.

The focus of the Annual Computational Science Symposium is to continue the work initiated at the previous annual meetings by bringing FDA, industry and academia together to provide an update on current initiatives ongoing within the FDA, explore emerging technologies and establish collaborative working groups to address current challenges related to the access and review of data to support product development. Previous work has included the creation of a Study Data Reviewer's Guide Template for submission, development of a non-clinical road map and the application of semantics technology to standards.

Working Groups

Since the 2013 CSS, the projects within the working groups have been meeting, collaborating and delivering valuable outputs as part of their objectives. Click here to see the summary of the working groups and their overall objectives moving into 2014.

Over the past year, the Working Groups have successfully delivered on a number of their goals to better support industry and FDA. Below are some of those successful projects.

•    Study Data Reviewer’s Guide (SDRG) – A standardized template providing best practices and recommendations for information needed within a submission

•    Gap Analysis of Site Select Data Elements – A summary of the gaps between data elements needed for reviewing site selection and the CDISC standards provided to CDISC for incorporation in standards development

•    PhUSE Google Code Repository – Central and open repository for sharing any kind of code for common clinical data transformation and analysis

•    Release of First Standard Analysis White Paper – Released a white paper on Standard Analyses and Displays Associated with Measures of Central Tendency

•    Delivery of CDISC Standards in RDF – Implementation of the CDISC standards within RDF, a robust model for standards development and system interoperability.

NEW In 2014!

In addition to the regularly scheduled activities including an opening session by the FDA, working group collaboration, poster session and networking, new and exciting activities are being planned.

CSS Scriptathon

The 2014 CSS will feature the first ever "Scriptathon" - a hands-on opportunity to jump-start the Standard Scripts Working Group code repository! Participants will collaborate to create standard scripts for predefined targeted analyses using various code languages. The group will meet during the conference and on Monday evening to bang through some code. Join us for food, beverages and a hands-on opportunity to jump-start our code repository! Note that participation will be limited, so sign up early.

Sunday Networking Event

With so many attendees arriving on Sunday evening, we will host an informal networking session with drinks, snacks and the opportunity to browse the posters. Join us on Sunday evening and network with your colleagues from across industry and FDA.

More Presentations!

Responding to feedback over the last two years, this year’s conference will include more presentations focused around the topics and projects within each of the Working Groups.

New Projects

As part of the CSS, the Working Group Steering Committee is accepting proposals for new projects. A proposal will address problems of significant relevance to computational science related to drug, biologic and device development and must meet all of the guidelines for projects within the CSS collaboration. Click here for more information and to download the New Project Request Form. New projects can be submitted at any time but there is a deadline of December 31 to be included in the 2014 March meeting.

Conference Dates

The conference will commence at 5pm on Sunday, March 16th with the opening networking session and end at 5pm on Tuesday, March 18th.

Online registration will open the first week of November and the Symposium is limited to only 300 attendees so register early before the event is sold out. Advanced onsite registration will open on Sunday, March 16th between 4pm - 5pm.

Click here for details on the working and project groups.