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"In a clear presentation it gave a perfect insight into our struggle with SDTM and legacy data"



PhUSE Computational Science Symposium
March 13th – 15th 2016

Download the Flyer Here

The 5th annual Computational Sciences Symposium (CSS) in March of 2016 bringing together FDA, PhUSE and Industry in a collaborative event. The annual CSS 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 on-going 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 study data standardisation plan referenced in the recent guidance and the forming of a Statistical Computing Environment project to align industry requirements.

Working Groups

Since the 2015 CSS the projects within the working groups have been meeting, collaborating and delivering valuable outputs as part of their objectives. Click here to view the Computational Science Dashboard describing all the projects with links to information about each one.
  • Non-Clinical Study Data Reviewer’s Guide: Extension of the SDRG, a standardized template providing best practices and recommendations for non-clinical information needed within a submissions

  • 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

  • GitHub Google Code Repository: Central and open repository for sharing any kind of code for common clinical data transformations and analyses

  • Study Data Standardization Plan (SDSP): Development of a recommended study data standardization plan early in the development cycle to optimize implementation of data standards is the focus of this new project.

2016 Conference Highlights

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

Sunday night Kick-off
In 2016 the conference will begin on Sunday evening at 5 pm. The opening session will include a welcome by Steve Wilson from the FDA, an overview of each Working Group and their plans for the meeting, and break-out sessions for the working groups to gather and catch up.

Semantics 101 for Clinical Data Workshop
Semantic technology is poised to have significant impact oin the pharmaceutical industry. Historically, the entry barrier has been high for new users who are quickly overwhelmed by text-book discussions on ontologies and reasoning. Uptake has been further hampered by an absence of user-friendly interfaces and a lack of industry-relevant examples. This two-hour session will provide a pragmatic introduction to Linked Data concepts by exploring the foundations of Linked Data and the Resource Description Framework (RDF) using practical examples based on CDISC standards and sample analysis results from clinical trials. The SPARQL language will be used to query and link data from local and remote sources. Through this session you will obtain a working knowledge using tools common in our industry, that you may then apply to your own Linked Data projects. No previous experience assumed.

Hands-on with GitHub and the PhUSE Standard Script Repository Workshop
The Standard Scripts Working Group has developed a Script Repository for sorting shared code which utilises the GitHub platform. This session will explore the philosophy of Git and the GutHub environment. Participants will focus on the GitHub structure for PhUSE's Standard Scripts, the placement of content for the central tendency package and the creation of an Index page for the Standard Scripts. Attendees should bring a device with a web browser (laptop, chrome book or a decent-sized tablet) and be ready to learn what real code management is all about. 

  The Symposium is limited to only 300 attendees, so register early to avoid disappointment.