News: Registration, FDA News, CS Working Group Activities

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Silver Spring (MD), 06January2015

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Registration is Open

The 2015 PhUSE CSS event will be held from Sunday 15th March to Tuesday 17th March. Exhibition and sponsorship opportunities are available. Full details can be found on the website.

Key Dates: Early Bird Registration Closes-16th January

Poster Submission Closes-16th January Book the Conference Hotel-Now

FDA News

Final FDA guidance for Industry published on Providing Regulatory Submissions in Electronic Format On 17th December the FDA published the final version of the guidance for industry on Providing Regulatory Submissions in Electronic Format. The FDA guidance instructs sponsors of pharmaceutical products on how to submit new product and trial applications using the electronic Common Technical Document (eCTD) format. At least 24 months after the issuance of this final guidance document certain submission types must be submitted electronically and in the format specified by the FDA. The FDA guidance can be found on the FDA website:

CS Working Group Activities

CDISC has opened a public review of the CDISC Foundational Standards in RDF, prepared by the Semantic Technology Working Group. This package includes a Reference Guide, a Reviewer's Guide and the RDF files published on GitHub. These guides can be retrieved from the CDISC announcement here. This is a significant milestone for the Semantic Technology Working Group as these materials are expected to provide the groundwork for the future RDF export from CDISC SHARE. Please review and comment on the materials using the CDISC Public Comment Tracker. The Emerging Trends and Technology Working Group hosted a series of virtual round tables to gather ideas for new PhUSE Collaboration projects. The final round table occurred on 6th January 2015 and new projects will be announced shortly. If you missed the round tables but have an idea for a new PhUSE Collaboration project please submit your idea here.

The Standards Script Working Group has dozens of R and SAS scripts that have been contributed to our repository. We want these scripts to be of high quality and to inspire confidence from their first use. For this we need your help to exercise and refine our qualification process and invite you to join our teleconference in January to kick off these efforts. Please contact Dante Di Tommaso for details. Additional information about the project can be found here

Check [[1]] for more details.

About the CSS

The Annual Computational Science Symposium (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 CSS 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.

For more details on the CSS see here

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About PhUSE

PhUSE, Share – Contribute – Advance, provides the industry with the premier platform for creating and sharing ideas, tools and standards around data, statistical and reporting technologies; PhUSE is a non-profit, volunteer-supported, community of professionals who are passionate about advancement of clinical information. Since its inception, PhUSE has expanded from its roots as a conference for European Statistical Programmers, to a global platform for the discussion of topics encompassing the work of Data Managers, Biostatisticians, Statistical Programmers and eClinical IT professionals.