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FDA/PhUSE 2013: A Working Group Overview


d-Wise Technologies will be participating at this year's FDA/PhUSE event in Silver Springs, MD. March 18-19.

PhUSE logo CSS

The event will provide updates on collaborations with project groups to improve standards, software tools and processes across regulatory review and computational science. The FDA/PhUSE collaboration was created to provide high-quality quantitative analysis of information on product safety, effectiveness and quality. The core infrastructure for FDA's scientific community will help support ongoing efforts in pre-market development, modernization of drug review, post-market safety and drug quality. Key projects within the FDA's Computational Science Center are in areas of developing data standards and expanding the use of electronic review tools.

The collaboration between the FDA and PhUSE was previously organized into 6 Working Groups:

  • Working Group 1 - Data Validation and Quality Assessment
  • Working Group 2 - Reducing Risk within the Inspection Site Selection Process
  • Working Group 3 - Challenges of Integrating and Converting Data across Studies
  • Working Group 4 - Standards Implementation Issues with the CDISC Data Models
  • Working Group 5 - Development of Standard Scripts for Analysis and Programming
  • Working Group 6 - Non-Clinical Road-map and Impacts on Implementation

This year the working groups will be re-organized from 6 to 5 in order to maximize efficiency. These new groups will have a broader focus but will include specific well-defined projects on their agenda. The new groups, listed below, will have project lists and open discussions about any issues or gaps that should be addressed.

1) Emerging Technologies: This working group provides a forum for determining interest in specific computational science topics and sharing new tools, technologies and approaches for addressing scientific and regulatory challenges. Possible projects include: Prioritization, development and piloting of these potential solutions for feasibility and value.  

2) 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.

3) 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. Projects include:

  • Study Data Reviewer’s Guide (SDRG)
  • NEW) CDRH Pilot for the ElectronicSubmission of Medical Device Data in an SDTM-Based Format
  • NEW) Analysis Data Reviewer’s Guide (ADRG)
  • (NEW) SDTM Exceptions

4) 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. Projects include:

  • Standard Script Repository
  • Standard Scripts Development

5) 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 non-clinical informatics efforts and to develop specific implementation solutions and SEND. Projects include:

  • Nonclinical Data Interconnectivity 
  • Nonclinical Historical Control
  • Interorganizational SEND
  • SEND Implementation User Group
  • Nonclinical Standardization Roadmap

To Register for this Event, please click below:


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