FDA Working Groups
This wiki is available to document the progress of the FDA/PhUSE Computational Science Symposium working groups and projects. The wiki enables quick,easy and transparent online collaboration. Working groups each have a main page which is the starting page for all Working Group activity.
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FDA/PhUSE Working Groups
Over the last few months the CSS Steering Committee has performed a formal review of each working group's mission, objectives and progress since the last meeting. Based on this review and to maximize efficiency and organization, the groups will be re-organized into fewer working groups with broader focus, with each working group having multiple well-defined projects.
Improving Data Quality This working group will focus on collaborating to develop a robust process to rapidly validate and assess data quality as data moves through product lift cycle across both industry and regulatory review. The group will discuss current pains and potential solutions regarding topics such as current data validation rules, therapeutic specific data issues and improving the quality of the data to support specific analytical needs.
Optimizing the Use of Data Standards The development and adoption of data standards over the last decade has shown significant promise in improving efficiencies in the product submission and review process. However, there have also been gaps, issues and challenges in the interpretation and use of the standards. This group will identify specific gaps preventing FDA and industry from optimizing the use of standards and collaborate to close those gaps.
Development of Standard Scripts for Analysis and Programming With the development and implementation of industry data standards, there is a great opportunity to develop standard reporting across industry and to support the needs of FDA medical and statistical reviewers. This working group will identify potential standard scripts for data transformations and analyses across an within therapeutic areas. The goal will be to begin the process of standardizing analyses across the industry, but also include examples of what can be done with a standardized data set.
Non-Clinical Road-map and Impacts on Implementation There is a need to improve nonclinical assessment and regulatory science by identifying key needs and challenges in the field and then establish an innovative framework for addressing them in a collaborative manner. The group created a framework for moving certain projects forward to support nonclinical informatics efforts and to develop specific implementation solutions and SEND.
Emerging Technologies This emerging technologies working group will be an open, transparent forum for sharing pre-competitive means of applying new technologies and is being challenged with creation of well-defined collaborative projects that will describe, prioritize, assess, and assist advancement of these opportunities. Possible topics include (but are not limited to) semantic web applications, analysis metadata, modeling, simulation, and “The Cloud”.
FDA/PhUSE 2012 Archived Working Groups
Working Group Oversight
Below is a list of Working Group and Project oversight information.
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FDA comments are an informal communication and represent the individual's best judgment. These comments do not bind or obligate FDA. The contents of this wiki are from the individual contributors and do not necessarily reflect the view and/or policies of the Food and Drug Administration, the employers of the individuals involved or any of their staff.Current user rating: 97/100 (2 votes)