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Computational Science Annual Meeting to Discuss FDA Developing Bioinformatics Platform

Horsham, PA, USA — Mar 08, 2010

The Drug Information Association (DIA) and the US FDA will host the first DIA/FDA CDER/CBER Computational Science Annual Meeting from March 22-23 in Bethesda, MD.

Experts from the US FDA Centers for Drug and Biologics Evaluation & Research (CDER, CBER) will deliver updates on:

  • Quality metrics and cases regarding data submission quality
  • Process 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 problems solving quality, efficiency, and cost
  • Regulatory data submission 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

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 breakouts will form the nuclei of working groups that can collaborate on an ongoing basis to discuss issues and create solutions in these five areas:

  • Preapproval – Nonclinical: Current state of practice and steps forward for review of pharmacology/toxicology information in support of premarket regulatory review of drugs and biologics.
  • Preapproval – Clinical: Future informatics review state and the use of standardized data to improve drug review.
  • Post-market Safety:  Needs, challenges, and solutions for three major aspects of handling postmarketing safety data: data efficiencies, analytic approaches, and oversight of postmarketing inspections and data verification.
  • Product Quality: Current use of computational tools and technologies to facilitate rapid, in-depth understanding of product quality data, and exploration of future opportunities.
  • Data Quality: Advances in computational methods for detecting risks to data quality and public health

“The ability to acquire, store, analyze, share, and report information is one of the most important and unrecognized issues that contribute to drug development and regulatory productivity and quality,” says Program Co-chair Stephen E. Wilson, DrPH, CAPT. USPHS, Director, Division of Biometrics III, CDER, FDA. “We invite you to participate in a forum where stakeholders will review progress in areas such as data standards, best practices-driven analytical tool development, business processes driving information systems development, and user experience/evaluation of current tools.”

 

 

 

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ABOUT DIA: DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. The dedicated efforts of DIA staff, members and speakers enable DIA to provide a comprehensive catalogue of conferences, workshops, training courses, scientific publications and educational materials. DIA is a global community representing thousands of stakeholders working together to bring safe and effective products to patients. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org.