FDA/PhUSE Annual Computational Science Symposium Silver Spring Civic Center, Silver Spring Maryland, USA

February 2, 2012

Company News Release

PhUSE is delighted to announce that the forthcoming Computational Science Symposium with the Food and Drug Administration is open for registration.

This meeting is a unique opportunity to be informed of the latest updates and current initiatives from the FDA, industry, and academia. This is the 3rd Annual Meeting and will build on the progress made at previous events. There will be opportunities to establish collaborative working groups that address current challenges relating to the access and review of data. The ability to enhance current models to efficiently acquire, store, and analyze the data will be at the heart of the meeting agenda.

PhUSE is delighted to confirm that Charles Cooper, MD, and Steve Wilson, DrPH, of the FDA will be welcoming delegates to the Symposium alongside other representatives of CDER & CBER. In addition, a representative from CDISC will be presenting the latest updates to the data standards models. The program will then be organised into six working groups which will allow delegates to work together to discuss real world issues and how to solve them. . The working groups’ steering committee has been meeting regularly to develop an overall process and structure for the groups. Each group has co‐leads that have produced a high level list of potential topics for discussion. Unlike other forums, this event is a ‘hands‐on’ meeting that will enable those who work most closely with clinical data to debate, comment on and develop new innovative working solutions to some of theindustry’s challenges.

Ben Szilagyi , PhUSE Industry Links Director stated, “This is a great opportunity for our industry to share our expertise, know‐how, and energy to come up with novel solutions for improving the product development process. We are excited to partner with the FDA on these working groups and are looking forward to a great event.”

For registration, please follow the link: http://www.phuse.eu/ssreg.aspx

PhUSE is an independent, not‐for‐profit organization run by volunteers. 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.

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