13:00 - Workshop One - More Than An Introduction to Extractables and Leachables
Sponsored by Safebridge
This workshop offers more than just introductions to the topics, but practical case studies and examples on how to put together all aspects to develop a compelling submittal to regulatory agencies for acceptance.
Extractables and Leachables are a complex subject that requires a “team” of analytical chemists, toxicologists and regulatory experts to understand the nature of the drug product, test appropriately, conduct a toxicological risk assessment and interpret the data.
Workshop Speakers:
14:30 - Networking Break
15:00 - E&Ls Risk Assessment Under ICH Q3E ensuring quality method design and incorporating in silico approaches alongside existing safety data
Sponsored by Lhasa Limited
Are you navigating the complexities of Extractables and Leachables (E&L) risk assessment under ICH Q3E? In this workshop, we will discuss the complexities of E&L risk assessment, particularly in light of the new ICH Q3E guideline. We will talk through how to efficiently design target methods based on a complete understanding of leachable risk within drug formulation and how to then effectively link leachable studies to extractable results. Another key focus will be working through practical workflows and optimisation techniques, highlighting how advanced in silico tools can overcome common challenges in E&L safety assessments, leading to faster, more cost-effective, and defensible outcomes for both the pharmaceutical and medical device industries.
Workshop Speakers:
17:30 - Networking Drinks Reception
