This is the most important E&L conference in Europe, which is great - Senior Consultant, Intertek
Extractables & Leachables Europe is the world's leading conference dedicated solely to extractables and leachables.
The conference covers the regulatory landscape, advances in science and testing methods, the latest technological developments, biocompability, biomanufacturing, BPOG vs. USP, as well as featuring case studies from leading experts in the field.
How attending this conference will benefit you:
Ron Brown is a board-certified toxicologist who recently retired from the US FDA Center for Devices and Radiological Health. At FDA, his research efforts focused on the developing new methods to assess the risk posed by patient exposure to extractable and leachable compounds released from medical device materials. He is active in both domestic and international standards committees related to the biocompatibility of medical devices. Until recently, he served as the co-chair of the US TAG for TC194 (Biological Evaluation of Medical Devices) and as convener of ISO/TC194/WG11 (Allowable Limits for Leachable Substances). Ron is a founding member and former president of the Medical Device Specialty Section of the Society of Toxicology. He previously held leadership roles in the Society for Risk Analysis and the Association of Government Toxicologists. Prior to joining FDA, he was a Senior Associate at the ILSI Risk Science Institute in Washington, DC.
Thomas Egert is a research scientist at Boehringer Ingelheim, Germany. Dedicated to analytical chemistry for 20+ years, his current role includes responsibility for materials selection and E&L qualification as well as analytical troubleshooting during packaging development.
Thomas is an active member of the Extractables and Leachables Safety Information Exchange Consortium (ELSIE) and the PQRI Parenteral and Ophthalmic Drug Product (PODP) – E&L Working Group. While contributing to several industry seminars in the field of pharmaceutical packaging, his special interest is devoted to predictive physico-chemical models for mass transfer from primary contact materials into pharmaceuticals.
Prior to joining Boehringer Ingelheim, Thomas held various positions in the field of organic trace analysis at an analytical service provider. Thomas holds a diploma in chemical engineering and a master’s degree in bio- and pharmaceutical analysis.
I graduated a Ph. D. in analytical chemistry in 2008 at Ecole Nationale de Chimie de Paris (Chimie ParisTech nowaday).
After a short experience in the petrochemical industry, I worked for 7 years for Aptar Pharma, Injectables division (formerly Stelmi) and started to be involved in the field of Extractables and Leachables studies. I acquired there a good experience on rubber extractables.
I then joined Sanofi at the beginning of 2017 as Analytical Senior Scientist. I am in charge of the analytical chemistry activities within a group that is dedicated to the evaluation of primary container for parenteral drug products. Today my main activity is the E&L field, mainly for Prefilled syringes. I am also involved in other activities, like Container Closure Integrity testing.
Chemist by training, she was working for the past 10 years in the GSK Vaccines incoming material qualification related domains, her main responsibility included the creation the SUS and Primary Container validation standard approach to be applied directly to all the company manufacturing sites while following several qualification and implementation project for single use bags and connectors and vaccine primary packaging and delivery system. Main objectives was robustness of the qualification package supporting the use of incoming material along-side harmonization and standardization. She is now in charge of the E&L expertise since beginning of 2018, her current role includes responsibility to set the E&L testing requirement at the right level into the company and management of the expertise across the organisation.
Margot Reth is responsible for the E&L laboratory at F. Hoffmann-La Roche in Basel (Switzerland).
Dedicated to analytical chemistry for 15+ years, her current role includes responsibility for the E&L investigation of primary packaging and single-use process equipment as well as for material related analytical trouble shooting. As E&L subject matter expert Margot is involved in risk assessments and in the implementation of global strategies for E&L testing for development and commercial projects.
Prior to joining F. Hoffmann-La Roche, Margot held various positions in the field of organic trace analysis and E&L testing at Ciba Speciality Chemicals, BASF, and at the analytical service provider Intertek.
Margot holds a state exam in food chemistry and has a PhD in mass spectrometry.
Alicja is currently employed at the Octapharma Pharmazeutika Produktionsges.m.b.H. where she is responsible for material qualification at corporate level. She performs extractables and leachables assessments including the planning and supervision of extractables and leachables studies.
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. As a family-owned company, Octapharma believes in investing to make a difference in people’s lives and has been doing so since 1983; because it’s in our blood. Octapharma employs more than 6,200 people worldwide to support the treatment of patients in 105 countries with products across three therapeutic areas: critical care, haematology (coagulation disorders), immunotherapy (immune disorders). Octapharma owns five state-of-the-art production facilities in Austria, France, Germany, Mexico and Sweden. For more information visit www.octapharma.com.
Smithers helps medical device and pharmaceutical product manufacturers bring innovative, safe and highly effective products to market with world-class expertise and extensive, independent testing capabilities at accredited facilities in the UK and USA.
Our experienced team will provide advice, guidance and recommendations as well as delivering test data to help you demonstrate compliance to regulatory guidance or specifications set out by the FDA, EMA, MHRA, USP, ASTM and ISO.
We can assist throughout your medical device product development.
Services include:
E&L Europe continues to grow and is clearly the premier event of its type - Executive Partner, SCIO Analytical
