9-11 November 2026
Vienna, Austria
Smithers has accumulated more than four decades of expertise in organising global events and curating enlightening and informative conferences that offer valuable networking prospects. E&L Europe is dedicated to the science, testing and regulatory landscape of extractables and leachables in pharmaceuticals and medical devices. The event is attended by CEO's, senior principal scientists, researchers, presidents, chemistry directors, lecturers, R&D managers and pharmacologists to name a few.
Next taking place on 9-11 November 2026 in Vienna, Austria, the event brings together global experts from across the E&L supply chain to share the latest scientific insights, regulatory developments, analytical methods and real-world case studies.
As extractables and leachables continue to play a critical role in drug safety, packaging compatibility and regulatory compliance, the conference provides a platform for professionals to explore best practices in E&L testing, risk assessment and materials characterisation.
Philippe Verlinde, Ph.D. Ir. Senior Scientist - Study Director Dr. Verlinde received his Ph.D. from the Faculty of Bioscience Engineering at the University of Leuven (Belgium) in 2009. He worked as a postdoctoral fellow at the University of Leuven (Bioscience Engineering), conducting research in the field of food technology and analytics.
From 2010 to 2013 he joined the Institute for Reference Materials and Measurements (IRMM) of the European Commission’s Joint Research Centre as a scientific support officer and was involved in several research projects in the field of method standardization (CEN, ISO), proficiency testing and regulatory aspects of environmental pollutants and food safety. Due to his background he has gained a strong expertise in analytical chemistry, especially in the field of structural elucidation techniques (NMR, MS), method development and validation, trace analysis by chromatography (GC & LC) hyphenated to mass spectrometry (small molecules). In 2013 he joined Toxikon Europe as an analytical expert and study director at the Pharma Department, focusing on impurity identification projects.
Since 2016 he is acting as a senior scientist in the R&D team at Nelson Labs Europe and is involved in automation projects and the development of state-of-the art analytical services related to extractables and leachables studies for the pharmaceutical and medical device industries.
Rita Beel is the Group Lead for Extractables & Leachables at Fresenius Medical Care. A chemist by training with a background as a certified lab technician, she brings over 20 years of experience in different mass spectrometry fields and 15 years in non-targeted analysis. For the past 12 years, she has specialized in E&L within highly regulated environments. Having held previous roles including E&L study director and laboratory manager for MS, her current focus is on establishing state-of-the-art, regulatory-compliant chemical characterization processes.
Berk Oktem is a Chemist and Toxicologist at US FDA’s Center for Devices and Radiological Health, Office of Orthopedic Devices. He serves as a lead or technical expert for pre-market reviews and conducted research focused on extractables, leachables analysis, small molecule identification and analysis, polymer degradation and proteomics for more than 20 years. He received his Ph.D. in Analytical Chemistry from the University of Delaware, performed post-doctoral research at Johns Hopkins School of Medicine and also spent 10 years in private sector as research and applications scientist in product development of chemical analysis systems prior to joining FDA.
Raphael (Raphy) Nudelman is a senior pharmaceutical R&D, regulatory-science, and toxicology leader with more than 25 years of multidisciplinary experience spanning impurity science, chemical and computational toxicology, medicinal chemistry, computational metabolism, drug discovery and development, and R&D operations.
Former Senior Director, Impurity Expert, R&D Operations, and Director of Chemical & Computational Toxicology at Teva Pharmaceutical Industries, where he established and led the Chemical & Computational Toxicology unit for more than a decade. Brings extensive experience in toxicological risk assessment and chemical-safety evaluation across pharmaceutical development and product lifecycle management, including mutagenic and non-mutagenic impurities, nitrosamines/NDSRIs, degradation products, solvents, elemental impurities, extractables/leachables, excipients, and occupational hazards.
Expert in ICH Q3A–Q3E and M7 implementation, QSAR assessment, and OHC/HBEL banding. Combines deep scientific expertise, practical regulatory insight, and strategic leadership to deliver robust, pragmatic, and evidence-based solutions for complex pharmaceutical safety challenges.
Dr Nazli Ozdemir is Founder and Director of Gulsine Ltd, a London-based computational materials and digital analytics company specialising in materials ageing, degradation prediction, and regulatory validation. She leads development of the A2P2-AI platform for predictive polymer degradation modelling and is a UK partner in the Innovate UK Eureka REFLOW project on polymer recycling and lifecycle assessment.
Nina Macho graduated in nutritional sciences at the University of Vienna, and in toxicology at the Medical University of Vienna. After investigating dietary factors which protect against DNA damage at the Cancer Research Institute of Vienna, she worked in the field of ecotoxicology at the Austrian Institute of Technology. In 2013 she joined the Department of Pharmacology and Toxicology at Octapharma, where she is responsible for toxicological risk assessment of impurities in biopharmaceutical products. Since 2023, Nina is board member of the ELSIE Consortium and participating in several toxicological working groups.
GBA Pharma operates from two GMP-certified, FDA-inspected labs in southern Germany, specializing in pharmaceutical, biotherapeutic, and medical device analysis. With 170+ experts and decades of experience, GBA provides quality control, method development, raw material testing, stability studies, microbiological analysis, and regulatory support—ensuring compliance and quality throughout the product lifecycle for global clients.
In our qualified laboratory the relevant expert knowledge is available and we guarantee that your E&L study is thoroughly planned, the appropriate methods are competently chosen and the experimental phase is carried out by experienced and well-trained staff. Our Customers outsource each step to GBA and our senior regulatory affairs experts along with our highly experienced and qualified E&L experts team support at each step:
i) Planning and Risk Assessment
ii) Extractables Study
iii) Toxicological Assessment
iv) Leachables Study
Make use of GBA’s services and experience in case of the complete qualification of a packaging material, the identification of leachables, the response to a letter of deficiency, and many more.
Intertek Pharmaceutical & Medical Device Testing Laboratory Services
Intertek’s Switzerland laboratory in Reinach, near Basel, is a leading analytical testing facility serving pharmaceutical, medical device, drug delivery, chemical, packaging, polymer, and consumer healthcare sectors across Europe and globally.
The lab operates to GLP-compliant standards, is WHO-prequalified (since 2014), ISO 17025 and ISO 9001 certified, GMP compliant, and FDA inspected.
With over 30 years of experience, services include: extractables and leachables, method development and validation, pharmaceutical analytical support, impurities/genotoxic impurities analysis, particles and foreign matter investigation, counterfeit medicine investigations, ICH stability services, polymer analysis, medical device chemical characterisation, and quality control testing.
Get in Touch
Partner with us to accelerate your product development and ensure regulatory confidence.
Tel: +41 (61) 686 48 56
Email: business.support@intertek.com
Online: www.intertek.com/analytical-laboratories/switzerland
