Thursday, 3 March 2011

DIA/FDA conference discusses use of (Q)SAR to assess impurities for potential genotoxicity

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

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:

* Strategies for Classifying and Controlling Potentially Genotoxic Impurities in the Pharmaceutical Industry.
* Regulatory Perspectives: FDA, EU, and Japan.
* What Current (Q)SAR Computational Models Can Tell Us about Ames. Predictivity.
* Industry Use of (Q)SAR: Overview and Case Studies.
* Integration of (Q)SAR into Hazard Identification: Role of ICH.

Dr David Jacobson-Kram, Associate Director of Pharmacology and Toxicology, Office of New Drugs (OND), CDER, FDA, will deliver the keynote address titled: “Use of in Silico Analyses for Mutagenicity Predictions: State-of-the-Art and Regulatory Implications.”

Since 1976, Dr Jacobson-Kram has published more than 80 abstracts, 60 peer-reviewed articles, and 30 review articles or book chapters. The majority of these publications deal which methods and issues in genetic and molecular toxicology.

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