Join Nelson Labs in Seoul for an Extractable & Leachables Training Course!
Course Overview
This training delves into the critical field of Extractables & Leachables (E/L) in relation to parenteral drug products, exploring the intersection of safety, quality, and regulatory compliance. Given the sensitive nature of parenteral administration, understanding the interaction between drug products and the materials they come in contact with—from manufacturing through administration—is vital.
The course spans:
- Regulatory expectations (FDA, EMA, USP, PQRI, ISO, BPOG)
- Material science and polymer chemistry
- Analytical methodologies for E/L testing
- Designing and interpreting E/L studies
- Safety and toxicological risk assessments
Who Should Attend
This course is ideal for professionals working in:
- Pharmaceutical Packaging & Device Engineering
- Production Engineering (especially using Single-Use (SU) systems)
- Regulatory Affairs
- R&D for Biopharmaceuticals
- Analytical Chemistry focused on E/L
- Quality Assurance and Compliance
Learning Objectives
Upon completion, participants will be equipped to:
- Regulatory Insight
- Understand and explain current regulatory requirements for container/closure (C/C) qualification from an E/L perspective.
- Anticipate and prepare for upcoming regulatory changes (PQRI, USP, BPOG, ISO 10993) and their implications.
- Material and Polymer Science
- Understand composition and materials of construction of C/C systems and their relevance to product quality and patient safety.
- Study Design & Evaluation
- Design and execute robust E/L evaluation programs tailored to specific parenteral packaging systems (vials, syringes, cartridges, IV bags, etc.).
- Use analytical test data effectively to support regulatory submissions and internal quality evaluations.
- Safety and Risk Assessment
- Perform toxicological and risk assessments based on E/L data to ensure compliance with health authority expectations.
DOWNLOAD THE AGENDA HERE: Agenda
Don’t miss this opportunity to enhance your expertise and connect with professionals in the Extractables & Leachables Field. Register now!
Registration Details:
Registration is $175.
Deadline for all registrations is March 11, 2026.
Koen Smets
Senior Expert Extractables and Leachables
Koen Smets received his Ph.D. in chemistry from the University of Hasselt (Belgium) in 2013. After working as a post-doctoral researcher at the University of Hasselt, he joined Nelson Labs in 2014 as study director Extractables & Leachables. Currently, Koen is working as senior expert E&L with main specialization in testing of single-use process materials.
Sona Kovackova
Senior Expert Extractables and Leachables
Sona Kovackova earned her PhD in Organic Chemistry from the University of Chemistry and Technology in Prague, Czech Republic. She began her career as a Scientist at the Rega Institute for Medical Research, KU Leuven, Belgium, and later transitioned to Quality Control of medicines at the Belgian Institute of Public Health. In 2017, Sona joined Nelson Labs Europe where she specializes in Extractables & Leachables studies, leveraging her extensive background in both analytical and organic chemistry. Sona’s primary focus lies in injectable applications, where understanding the interaction between drug products and their primary packaging is critical.
Annick Gillet
Director, Consulting Pharma Services
Annick is an accomplished quality assurance professional. In her role as Director, Consulting Pharma Services, Annick leads the Ethylene Oxide (EO) sterilization projects at numerous Sterigenics facilities and supports the facilities as the technical expert with pharmaceutical project responsibility. A seasoned speaker, Annick presents at industry conferences—such as CPhI and the A3P International Congress Biarritz—and hosts webinars. Annick has also been published in Medical Design & Outsourcing. Annick often presents on innovative and customized solutions for terminal sterilization of pharmaceuticals.
Pieter Van Wouwe
Scientific expert
Pieter Van Wouwe received his Master’s degree and PhD in Bioscience Engineering at the University of Leuven in 2011. In March 2016, he started working at Nelson Labs as a project manager, initially mainly involved in scientific interpretations and the reporting of analytical results. Over the years, he has expanded his role and became responsible for designing pharma-related extractable and leachable studies for both packaging materials and process materials. More recently, he has broadened his expertise to include medical devices and combination devices. Providing support for extractables and leachables studies to both biopharmaceutical and medical device companies is one of his current focus points, while knowledge sharing - internally and externally - is also part of his current role at Nelson Labs.
