Workshop Objective: This workshop will engage invited stakeholders and key opinion leaders with expertise in the assessment of nitrosamines (NA), including Nitrosamine Drug Substance-related Impurities (NDSRI) detection and evaluation in order to achieve the following:
Note: In-depth technical discussions of data sets or methodologies are out of scope for this workshop. Similarly, regulatory policy discussions are also out of scope.
The Webcast is open all interested participants. Online viewers may submit comments via the chat feature. A moderator in the meeting room will review these comments and may introduce them into active discussion when/if feasible. Direct/live participation in the workshop is not available – the in-person event is by invitation only and is at capacity.
All of the meeting sessions (with exception of the breakout group meetings) will be broadcast live for viewing online via GoToWebinar. Online viewers may submit comments via the chat feature. A moderator in the meeting room will review these comments and may introduce them into active discussion when/if feasible.
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This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] to the nonprofit Health and Environmental Sciences Institute totaling $347,618 (U01FD006676-03S2). Approximately 80% of the workshop expenses ($39,000) are covered by U01FD006676-03S2. The remaining 20% of the workshop expenses ($10,000) are contributed by the nonprofit Health and Environmental Sciences Institute’s Genetic Toxicology Technical Committee (HESI GTTC). The HESI GTTC budget includes direct funding from multiple industry partners (www.hesiglobal.org) to support a range of genetic toxicology related research projects as well as substantial in-kind support from the GTTC’s academic, government, NGO, and industry partners.
The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.
About HESI: The Health and Environmental Sciences Institute is a 501c3 nonprofit organization that operates internationally to generate science for a safer, more sustainable world. For more than 30 years, HESI’s operating model has successfully engaged scientists from academia, government, nonprofit, and industrial sectors via active scientific collaboration. www.hesiglobal.org