Computational Science Working Group Co-Leads Update

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All,

It’s been a while since we sent out an update from the Steering Committee (SC) and apologies for that. The SC has been working on updating a number of processes and will be communicating those to the working groups. In addition, we will be sending out a monthly email to the Working Group/Project leads to provide an update. Please communicate these updates to your project teams. We will also be create a SC page on the Wiki to bring together our updates, processes, etc. and will document the bullets below on that page.

Steering Committee Processes
• The Steering Committee has 12 member: 4 industry members, 4 FDA liaisons, and 4 working group liaisons
• The Steering Committee now has communication and process sub-teams responsible for handling specific activities
• Project Deliverable Review – moving forward every deliverable that is going to be distributed to the larger community needs to be submitted to the SC for review. This is a high level review identify any potential conflicts and should, in most cases, be completed within 2 weeks. In addition, we are asking that the disclaimer below be added to every deliverable as there has been some concerns/discussions over the ownership of the deliverables.

Updates: • The CSS 2015 dates have been set (March 15-17) and the planning committee has begun meeting. Registration will open the beginning of November and we will be reaching out to all projects to ask for information leading up to the meeting
• Working Group Leads: We are in need of additional co-leads for both the Optimizing Use of Data Standards Working Group and the Emerging Technologies. If you know anyone who would be interested in these opportunities please contact Chris Decker at Chris.Decker@phuse.com
• PhUSE has signed a formal MOU (Memorandum of understanding) with CDISC defining their role in standards development and our role in addressing implementation of the standards. As you lead projects or start new projects think about how CDISC can contribute to that effort.
• Between now and the 2015 meeting we will be holding 2-3 webinars to educate the public on the activities within the working group. We had one of these webinars two weeks ago. If your project would like to present on a topic please contact Scott Bahlavooni (scott.bahlavooni@biogenidec.com) for more informtion

Once again thank you for your effort and support within this collaboration

CSS Steering Committee

Disclaimer to be added to all deliverables “Disclaimer : The opinions expressed in this document are those of the authors and do not necessarily represent the opinions of PhUSE, members' respective companies or organizations, or regulatory authorities. The content in this document should not be interpreted as a data standard and/or information required by regulatory authorities.”