http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?pr...
Date(s) And Time(s):
Mar 14 2011 8:00AM - Mar 15 2011 5:00PM
Location:
Sheraton National Hotel Arlington
900 South Orme Street
Arlington, VA 22204
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
Learning Objectives:
At the conclusion of this meeting, participants should be able to:
• Describe progress on data standards development and implementation between regulators and regulated industries
• Discuss best practices for developing data submissions to facilitate effective and efficient regulatory review
• Discuss the needs and proposed specification for new tools and solutions
Target Audience:
• Physicians, biostatisticians, epidemiologists, clinical pharmacologists, and other drug development and review scientists
• Professionals involved in data management, programming, information management, and software tool design who work in environments where drugs and biological products are studied, developed, and regulated
• Pharmaceutical industry professionals (nonclinical, pre-market, post-market development, IT)
• Contract research organizations
• Government organizations (FDA, NIH)
• Information management and bioinformatics companies
• Academics
• Toxicologists
Event Code:
11014
Contact Information:
Event Information:
Rachel Minnick, Program Developer
Telephone +1.215.442.6131
Fax +1.215.442.6199
Email Rachel.Minnick@diahome.org
Exhibit Information:
Jeff Korn, Worldwide Exhibits Associate
Telephone +1.215.442.6184
Fax +1.215.442.6199
Email Jeff.Korn@diahome.org