February 3-5, 2026 / In-person workshop / By invitation only

Released over 20 years ago, the ICH S7A guideline established an important framework to protect clinical trial participants and patients; however, persistent safety-related attrition and post-approval withdrawals underscore the need to revisit and evolve the guidance in light of scientific, technological, and regulatory advances.

This workshop aims to establish a shared vision and build consensus among regulatory and industry stakeholders on revising ICH S7A to inform and support a formal decision to reopen the guidance. Over three days, discussions will focus on identifying priorities, exploring practical and technical considerations, and outlining a coordinated path forward that will help shape the future of safety pharmacology and form the foundation for a revised ICH S7A guideline.