The 6th Extractables & Leachables Summit 2026 is a premier two day event bringing together global experts from pharma, biotech, medical devices and regulatory agencies to discuss the latest trends, challenges and innovations in E&L science.
Day 1 focuses on regulatory frameworks, advanced analytics and digital transformation, featuring updates on ICH Q3E, USP, FDA and EMA guidelines, breakthroughs in high resolution analytical techniques and the integration of computational toxicology and predictive modelling. Attendees will also explore methodologies for assessing cumulative E&L effects, aligning strategies across the product lifecycle and implementing sustainable, green testing practices.
Day 2 delves into biologics, single use systems and medical devices, covering sterility and standardization, analytical strategies for device-associated leachables, real world case studies and management of secondary leachables in complex biologics. Additional sessions address PFAS risk assessments, route specific packaging safety and immunotoxicology for safer, compliant products.
