FDA/Health and Environmental Sciences Institute/Safety Pharmacology Society Hybrid Workshop: ICH S7A and New Approach Methodologies (NAMs) in Safety Pharmacology July 28, 2026

Workshop | Mixed

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• Date: July 28, 2026
• Time: 9:00 a.m. - 4:00 p.m. ET
• Location: Attend In Person or Online; Virtual: Teams; In Person: FDA White Oak Campus; The Great Room; Building 31; 10903 New Hampshire Avenue; Silver Spring, MD 20993-0002; United States

Register

About This Event

The US. Food and Drug Administration (FDA) in collaboration with the Health and Environmental Sciences Institute (HESI), and the Safety Pharmacology Society (SPS) will host a hybrid public workshop entitled “ICH S7A and New Approach Methodologies (NAMs) in Safety Pharmacology” on July 28, 2026. This one-day meeting aims to unite representatives from regulatory agencies and industry to develop a cohesive vision and scientific rationale for revising the International Council for Harmonisation (ICH) S7A guideline, with the goal of gathering key stakeholder perspectives and building consensus to reopen the guideline.

This workshop will facilitate the exchange of practical, real-world experiences regarding the integration and utilization of NAMs within safety pharmacology, with the objective of identifying areas of scientific consensus between FDA and industry. By fostering dialogue and sharing case studies, the meeting aims to enhance regulators' understanding of the intended applications, benefits, limitations, and implementation timelines of NAMs models while providing comprehensive insights that will inform and support the forthcoming revision of the ICH S7A guideline. With the regulatory landscape increasingly emphasizing the reduction of animal testing—especially in light of the recent FDA roadmap—this collaborative forum will enable a thorough evaluation of the predictive capabilities of NAMs relative to traditional animal models, ultimately advancing patient safety and ethical standards of pharmacological research.

While this event will not result in specific changes to ICH guidelines, the information exchanged will be pivotal in shaping future regulatory policies and ensuring that emerging methodologies are appropriately validated, accepted, and implemented across the field.

Workshop Objectives

• Establish a shared, cross-regional understanding of NAMs in safety pharmacology
• Clarify regulatory opportunities and constraints for NAM inclusion in S7A
• Define clear, discipline-specific NAM use cases relevant to S7A
• Develop actionable recommendations and next steps to support NAM integration into S7A

Meeting Information

The workshop is free to attend; however, registration is required for both in-person and virtual attendance. For those who wish to attend in person, the workshop will take place in the Great Room, Building 31, FDA White Oak Campus at 10903 New Hampshire Avenue, Silver Spring, MD. Click here to register.

For questions regarding this event, please contact OCPWorkshops@fda.hhs.gov.

Workshop Materials

Agenda is forthcoming