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FDA/PhUSE Annual Computational Science Symposium

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Update on Standards, Tools and Process Initiatives Across Regulatory Review and Collaboration with Key Working Groups to Improve the Product Lifecycle.

The foundation of the product development process is the ability to efficiently acquire, store, and analyze the data and documents to make informed and timely decisions. The focus of the 3rd 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 and establish collaborative working groups to address current challenges related to the access and review of data to support product development. These groups will work on possible solutions and practical implementations with the goal of helping the broader community align and share experiences to advance computational science.

Information about working groups can be found here.



Are you interested in sitting down with industry colleagues and FDA representatives to solve the challenges we face within our industry? Do you want to share ideas and brainstorm about how to implement data standards, using tools, or defining standards analyses?

Come join a working group and participate. The only requirement is that you must participate and contribute. The working groups have set up a number of tools they are using for collaboration.

Learn about a working group:

The working groups will be using an online Wiki at www.phusewiki.org to post minutes, agenda and ongoing notes from the various topics identified within the groups. Just click on the links below to browse through the topics being discussed within the working groups.

Create a user account to add comments and participate in the discussion. The Wiki is an evolving platform for collaboration so please send any feedback or suggestions along to wikiadmin@phusewiki.org.

• WG1: Data Validation and Quality Assessment
  

• WG2: Standardizing Data within the Inspection Site Selection Process

• WG3: Challenges of Integrating and Converting Data across Studies

• WG4: Standards Implementation Issues with the CDISC Data Models

• WG5: Development of Standard Scripts for Analysis and Programming

• WG6: Non-Clinical Road-map and Impacts on Implementation 

Sign up for a working group:

Each working group uses an automated mailing list service to help co-leads communicate with volunteers. If you are interested in joining a working group, follow the instructions below.

• Navigate to https://www.listbox.com/subscribe/
• Enter in one of the six working groups below:

• CSS-WG1-Data-Validation
• CSS-WG2-Site-Selection
• CSS-WG3-Integration
• CSS-WG4-CDISC-Implementation
• CSS-WG5-Standard-Scripts
• CSS-WG6-Non-Clinical

• Enter your e-mail and click submit. You will then be prompted to enter your First and Last name which is required to participate in the working group
• You will then receive an e-mail that will provide a link for you to confirm your e-mail (Check those spam folders just in case)
• You are now subscribed and should receive information about upcoming meetings from working group co-leaders!