https://ntp.niehs.nih.gov/go/developers-forums

Method Developers Forums

New Approaches for Carcinogenicity Testing

August 21-22, 2024 – 9:00 a.m.-12 noon EDT each day – Online

Registration will not be required to view the webinar. A link to join the webinar will be available on this page before the meeting. Use the links below to add the webinar to your calendar.

As a follow-up to the publication of the report on Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies, ICCVAM and NICEATM will organize a series of Method Developers Forums (MDFs), each focused on a specific endpoint/toxicity, that provide an opportunity for NAMs developers to present their methods and regulatory issues with relevant stakeholders.

The first MDF will be held virtually on Wednesday, August 21 and Thursday, August 22 at 9:00 a.m.-12:00 noon EDT and will focus on NAMs for carcinogenicity testing. The webinar will feature presentations by selected method developers describing their methods and proposing how they may be useful for regulatory and/or industry stakeholders. Also participating in the webinar will be a panel of stakeholders representing potential government and industry users of the NAMs or the data they generate.

How to Submit a Method Proposal: Instructions for Developers

The video presentations below summarize regulatory and industry stakeholders’ information requirements and/or decision frameworks relevant to carcinogenicity. Method developers that are interested in presenting their methods in the MDF should view these videos. After viewing the videos, use these questions that correspond to the key considerations in the ICCVAM report as a guide to prepare a proposal submission on your method.

Proposals must be submitted as a PDF attached to an email message to [email protected]. The file size must not exceed 100 MB. Proposals must be received by 11:59 p.m. on Friday, July 26. We recommend creating a presentation using a slideshow presentation program, such as Microsoft PowerPoint, then saving the presentation as a PDF. Brief explanatory comments may be entered in the Notes pane and included on the final PDF file.

Download proposal template (Microsoft PowerPoint file)

Your proposal should address the key concepts that are applicable towards validating NAMs for regulatory purposes, as outlined in the ICCVAM Validation Workgroup’s report on Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies.

The MDF Steering Committee will review all entries. Submitters will be notified of the Steering Committee’s decision by Friday, August 9. If accepted, you must be available between 9:00 a.m.-12:00 noon EDT on August 21-22 to present your method at the MDF (virtual webinar).

Video Presentations of Information Requirements and Decision Frameworks

U.S. Consumer Product Safety Commission
U.S. Environmental Protection Agency - Office of Pesticide Programs
U.S. Environmental Protection Agency - Office of Pollution Prevention and Toxics
U.S. Food and Drug Administration - Center for Drug Evaluation and Research
U.S. Food and Drug Administration - Center for Food Safety and Applied Nutrition
National Cancer Institute
National Institute for Occupational Safety and Health
Occupational Safety and Health Administration
Agrochemicals Sector: Syngenta Crop Protection
Example Presentation: University of Ottawa