Sheraton National Hotel Arlington , Arlington, VA, USA
Mar 14 2011 8:00AM - Mar 15 2011 5:00PM
Review Progress on Data Standards, Comparative Effectiveness Research, and Tools that Support Analysis and Collaboration. One of the most important and unrecognized issues contributing to drug development and regulatory productivity and quality is the ability to acquire, store, analyze, share, and report information needed to make the most informed and rapid decisions. This annual meeting will have an FDA-centric focus on the current needs and implementation plans to help the broader community both align and share knowledge/tools to advance Computational Science. FEATURED TOPICS Regulatory submissions
• Share quality metrics and case studies regarding data submission quality
• Discuss, recommend and evaluate process and tools designed to assure adequate data quality supporting a successful review Tool development and evaluation
• Discuss the need and propose specifications for new tools
• Provide a forum for new tools to be introduced Impact
• Promote regulatory data submissions using standardized data
• Promote development of a bioinformatics FDA platform enabling electronic regulatory review of routine submissions and emerging safety and product quality concerns
• Promote the ability to learn from prior knowledge and apply this learning to improving the quality and productivity of both product development and regulation SPECIAL BREAKOUT SESSIONS In addition to the featured meeting topics, breakout sessions will drill down and explore the requirements, standards, tools, and activities needed to support specific aspects of drug development. These breakout sessions will form the foundation for working groups that can collaborate to discuss issues on and find solutions to challenges in:
• Clinical Data
• Comparative Effectiveness Research
• Post-market Data
• Community Repository of Program Code
• Electronic Case Report Forms and Data Standards
• Nonclinical Data
Event Code:
11014
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