We're putting the finishing touches to what is shaping up to be one of the most technically rich and practically relevant E&L programmes we've ever assembled.
Here's a taste of just some of the ground we'll be covering:
AI and Machine Learning Are Coming to E&L — And It's More Useful Than You Think
Several sessions will explore how artificial intelligence and machine learning are beginning to reshape how E&L studies are designed and executed — from smarter solvent selection to predictive modelling that gets ahead of leachables before testing even begins.
We'll also be dedicating a full session to an honest, balanced debate on where AI genuinely adds value in E&L workflows right now, where it still falls short, and whether it will ever truly replace the experienced consultant. If you've been wondering how to navigate the AI noise in this space, this programme will give you some clear answers.
The Evolving Regulatory Landscape — ICH Q3E, ISO 10993 and Beyond
Regulation is moving fast, and several sessions are dedicated to helping delegates stay ahead of it. We'll be covering the implications of ICH Q3E for toxicological risk assessment, the impact of the updated ISO 10993-1:2025 on biological safety evaluation for medical devices, and the growing challenge that evolving global PFAS restrictions pose for pharmaceutical component supply chains.
Whether you work in drug products, biologics, or medical devices, these sessions will give you the regulatory clarity you need heading into the second half of 2026.
Single-Use Systems — Deeper Than You Might Expect
Single-use bioprocessing continues to generate some of the most complex and consequential E&L challenges in the industry. This programme addresses them head on, with sessions exploring leachable profiles across full commercial manufacturing lines, the variables that influence them, and the sources of leachables that are still too often overlooked. You may leave reconsidering some assumptions about where risk actually sits in your single-use workflow.
USP <665> — From Compliance to Competitive Advantage
USP <665> is no longer on the horizon — it's here, and its implications are being felt across biopharmaceutical development and commercial manufacturing alike. Two sessions will tackle it from complementary angles, bringing both industry and independent laboratory perspectives. Expect practical guidance on interpretation, testing strategy, supplier collaboration, and how to turn a demanding regulatory framework into a genuine programme asset rather than just a compliance burden.
The Leachable Sources Nobody Is Talking About
Some of the most compelling sessions in this programme shine a light on leachable sources that have historically flown under the radar. From components that most manufacturers wouldn't think to include in an E&L risk assessment, to real-world studies that challenge assumptions about material safety in everyday medical devices — these sessions are likely to prompt some uncomfortable but important conversations.
Making Sense of the Unknowns in Your NTA Data
Non-targeted analysis is generating more data than ever — but unidentified compounds remain one of the most challenging aspects of any extractables programme. A dedicated session will present a structured, science-based approach to de-risking those unknowns and building more defensible NTA workflows, with particular focus on compounds that may belong to high-potency toxicological classes.
Early Bird tickets available until 7 August 2026 - save €250!
