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Computerized Systems for Nonclinical Safety Assessment

The 2006 Follow Up to the Red Apple Conference
DIA Headquarters

In 1987 the Office of Regulatory Affairs of the Food and Drug Administration, the National Center for Toxicological Research (NCTR) and the NCTR Associated Universities, Inc. conducted a conference at the Red Apple Conference Center in Heber Springs, Arkansas on quality assurance of computerized systems used in nonclinical safety assessment. The “Red Apple Conference” as it became known, was a milestone event in establishing best practices in the design and validation of computerized systems in nonclinical laboratories. The outcome of the conference was a reference published by the DIA, “Computerized Data Systems for Nonclinical Safety Assessment: Current Concepts and Quality Assurance”.  Although this publication has served the agency and the regulated industry well, nonclinical laboratory science and technology have changed significantly since the conference. The purpose of this conference is to review the original reference and update the material to address the current environment and new challenges confronting nonclinical laboratories.

Mr. Grunbaum will be part of a select group of international participants from industry, government and academia to participate in this effort.