FDA Forum to Promote Progress in Computational Science from Regulatory and Product Development Perspectives

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 in pharmaceutical companies, contract research organizations, and international regulatory agencies. This meeting will review progress on topics such as data standards, best practices-driven analytical tool development, business processes driving information systems development, and user experience/evaluation of current tools.

Highlights
• Software Showcase and Demonstrations
• Poster Presentations
• Interactive Exhibit Hall
• Breakout Sessions:
  – Nonclinical preapproval
  – Clinical preapproval
  – Postmarket safety
  – Product quality
  – Data quality
• Formation of ongoing Working Groups to address computational science issues and solutions from the Breakout Sessions

Featured Topics
• Quality metrics and cases regarding data submission quality
• Processes and tools designed to assure adequate data quality supporting a successful review
• Specifications for new tools
• Effectiveness of current tools
• Need-driven levels of tool training
• Impact of processes and tools on problem-solving quality, efficiency, and cost
• Regulatory data submissions that are efficiently loaded into the JANUS warehouse
• FDA and sponsor needs and plans
• Development of a bioinformatics FDA platform enabling electronic regulatory review of routine submissions and emerging safety and product quality concerns

At the conclusion of this meeting, participants should be able to:

·         Assess progress in data standards development and implementation between regulators and regulated industries;

·         Describe best practices for developing data submissions to facilitate effective and efficient regulatory review;

·         Outline the needs and proposed specification for new tools and solutions; and

·         Explain best practice (process, tools) implementation experiences and the subsequent impact on organizational performance.

·         Physicians

·         Biostatisticians

·         Epidemiologists

·         Clinical pharmacologists

·         Data management professionals

·         Information Technology professionals

·         Pharmaceutical industry (preclinical, pre-market, post-market development, regulatory, IT) professionals

·         Contract research organizations

·         Government organizations

·         Information management and bioinformatics professionals

MEETING INFORMATION

For further information contact Benjamin Zaitz, Program Manager, Phone +1.215.293.5803, Fax +1.215.293.5937 email Benjamin.Zaitz@diahome.org

EXHIBIT OPPORTUNITY

Limited space is available for exhibits which attendees are free to visit during the meeting and receptions. For further information, contact Shannon Lewis, Exhibits Associate, Phone +1 215 442 6149, Fax +1 215 442 6199, email Shannon.Lewis@diahome.org

The most convenient airport is Ronald Reagan Washington National Airport and attendees should make airline reservations as early as possible to ensure availability. The Bethesda North Marriott Hotel and Conference Center is holding a block of rooms at the reduced rate below until February 28, 2010, for the DIA event attendees. Room availability at this rate is guaranteed only until this date or until the block is filled.

Single $226          Double $226

Please contact the Bethesda North Marriott Hotel and Conference Center by telephone at 1-800-859-8003 or (301) 822-9200 and mention the DIA event. The hotel is located at 5701 Marinelli Road, Bethesda, MD, 20852, USA.