FDA/PhUSE Annual Computational Science Symposium (CSS 2012)
Update on Standards, Tools, and Process Initiatives Across Regulatory Review and Collaboration with Key Working Groups to Improve the Product Lifecycle.
March 19-20, 2012
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.
Pages in category "CSS2012"
The following 16 pages are in this category, out of 16 total.
- SEND Implementation
- SEND Implementation Intercompany Exchange of Data
- SEND Implementation Minutes
- SEND Implementation Minutes 2012-04-20
- SEND Implementation Minutes 2012-05-04
- SEND Implementation Minutes 2012-06-01
- Should SEND be listed in the Protocol or treaded only as a contract deliverable?
- Should SEND be listed in the Protocol or treated only as a contract deliverable?
- Should SEND output be reviewed by the GLP Quality Assurance Unit?
- Standardizing data within the Inspection Site Selection Process