FDA-HESI Research Roadmap Planning on Hazard and Risk Assessment of Nitrosamine Impurities in Drugs

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:

• Provide a high-level synthesis of key areas/objectives of current research on NA detection and evaluation;
• Identify short-term (1-2 years) research needs that can address data gaps required to improve nitrosamine (NA) risk assessments;
• Identify mid-term (3-5 years) and long-term (5+ years) research needs to improve nitrosamine (NA) risk assessments;
• Discuss potential opportunities and forums to realize the identified research gaps (e.g., FDA-initiated Public Private Partnership , existing or new consortial efforts, grants, private sector research efforts, etc.)
• Develop a NA-research roadmap in support of an uninterrupted drug supply that is also protective of public health.

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.

To View the Agenda and Register for the Webcast: Click here for the Event Page

For questions, please contact hesi@hesiglobal.org

Funding Statement
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