DIA/FDA Conference to Discuss Genotoxic Impurities Assessment

Industry scientists and regulators will address what constitutes an acceptable in silico evaluation and how to incorporate public and proprietary sources of data into an integrated assessment.

DIA and FDA will host the DIA/FDA Quantitative Structure-activity Relationship (Q)SAR Approaches to Assessing Genotoxic Impurities in Pharmaceuticals Conference on 7 April, 2011 in Rockville, Maryland, US.

Industry scientists and regulators will address what constitutes an acceptable in silico evaluation and how to incorporate public and proprietary sources of data into an integrated assessment. The timing of this particular workshop will provide critical input on the discussions for the June 2011 meeting for ICH M7 (Mutagenic Impurities). Session topics include:

1.Strategies for classifying and controlling potentially genotoxic impurities in the pharmaceutical industry

2.Regulatory perspectives: FDA, EU, and Japan