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.
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.
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