Join us for a free 2-day live event on June 16 & 17 in Leuven, Belgium. This Open House offers a deep exploration of today’s most important impurity‑related challenges in pharmaceutical development and manufacturing. Over these two days, attendees will dive into a broad range of scientific and regulatory topics that continue to shape product safety, quality and compliance.
This event covers the evolving landscape of nitrosamines, including their origins, formation pathways, risk factors, and the analytical strategies used to detect and quantify them. Broader impurity classes, such as genotoxic and mutagenic impurities, are also explored from both scientific and regulatory perspectives, highlighting emerging trends, risk assessment strategies, and practical considerations for impurity control. We will also explore the impact that a potential PFAS ban could have on the pharmaceutical industry and how the industry is preparing for it.
In addition, a large portion of the program is dedicated to extractables and leachables, including current global regulatory expectations for E/L, developing new standards in the E/L landscape (ICH Q3E) , how to assess the cumulative effect of leachable compounds in drug products, the importance of high quality leachable data in risk assessments, PERL evaluations, and the identification of reactive or product‑related impurities. Additional sessions focus on the adjacency of pharma impurities and leachable studies in Non-Targeted Analytical (NTA) methodologies, structure elucidation, and approaches for de-risking unknown compounds.
Throughout the event, participants will gain up‑to‑date insights, practical tools, and a clearer understanding of how impurity science is evolving. This will help participants to anticipate challenges, refine control strategies, and strengthen regulatory readiness.
Key learning perspectives of this event
- Understand current challenges and trends in pharmaceutical impurity control.
- Learn how nitrosamines form and how to evaluate their risk factors.
- Gain insights into analytical strategies for detecting and quantifying nitrosamines.
- Explore scientific and regulatory perspectives on genotoxic, mutagenic, elemental, and PFAS impurities.
- Learn how to apply extractables and leachables data in risk assessments.
- Discover approaches for identifying reactive or product-related impurities.
- Get practical guidance on screening techniques and structure elucidation.
- Learn strategies to de-risk unknown or unidentified compounds.
- Strengthen overall readiness for evolving impurity regulations and assessments.
There’s more…
The first day of the event concludes with a guided tour of the Nelson Labs laboratory facility, followed by a delightful networking event.
Don’t miss out on this unique learning experience!
