The 7th Annual Extractables & Leachables Summit 2027 is a premier two day global virtual forum bringing together biopharma leaders, medical device specialists, analytical scientists and regulatory experts to address the next wave of compliance, analytical precision and safety evaluation in E&L science.
Day 1 focuses on global regulatory alignment, cutting edge analytical workflows and digital innovation, offering practical insights into post implementation compliance for USP <665>/<1665>, final adoption pathways for ICH Q3E and evolving FDA/EMA expectations. Attendees will examine Non-Targeted Analysis (NTA) for identifying unknown peaks, in silico toxicology modeling, cumulative exposure methodologies across complex supply chains, food contact material crossover strategies and green chemistry initiatives in laboratory operations.
Day 2 concentrates on bioprocessing systems, combination products and advanced modalities, addressing single use technology qualification, revised ISO 10993-18 frameworks for medical devices and real world case studies in cell and gene therapies (CGT). Special sessions cover mitigating secondary leachable risks in sensitive biologics, PFAS regulatory risk profiling across packaging and process components, route specific safety evaluations and applying the Threshold of Toxicological Concern (TTC) for sensitization and immunotoxicology.
