Smithers have been organising the European, USA and China edition of the Extractables & Leachables conferences for over 15 years and have a long history of providing regulatory conferences so you can be sure that this conference will not only provide you with the most up to date information but also a great conference experience.
E&L Europe 2022 will take place on 7-8 November in Frankfurt, Germany.Whatever your level or position, and whether you're from a CRO, pharmaceutical manufacturer, packaging specialist, instrument or equipment manufacturer, research or academic institution, chemical company or OEM - this conference has something for everyone!
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TBA
Trish joined Pfizer in February 2020 as a Global Risk Assessment Services Toxicologist in Drug Safety R&D. Trish has a background in Genetic Toxicology and over the last 12 years has built expertise in mutagenic impurity, extractable and leachable, and contamination risk assessments. In recent years, Trish participated in ICH M7 working group to develop Appendix 3 and co-authored hydrogen peroxide monograph. In addition, she authored the vinyl acetate monograph in the subsequent publication Bercu et al., (2018). Trish is also the co-chair of the Extractables and Leachables Safety Information Exchange (ELSIE) PDE and Sensitisation Sub-teams and is an active member of the EFPIA working group to support ICHQ3E.
Jamie is a Director in the law firm of Faegre Drinker Biddle and Reath, LLP providing scientific and strategic consulting services to individual clients and various Pharmaceutical and Biotechnology consortia. He is particularly adept at helping clients streamline the development of new technology and data-sharing processes. As a scientist whose work has touched on various fields of study, Jamie is passionate about helping his clients cultivate new scientific knowledge and drive public policy changes that enhance the drug-development process. Within ELSIE, Jamie is one of the members of the ELSIE Secretariat. He is primarily responsible for the Knowledge Base project and data sharing initiatives currently underway in the consortium. Jamie has a BSc in biochemistry with a minor in computer science from SUNY Geneseo and a PhD in molecular biophysics and biochemistry from Yale University.
Caroline Jaegger is a technically proficient Mass Spectrometry Expert with 12 years laboratory experience and excellent academic qualifications (B.Sc., M.Sc., Ph.D.). Substantial experience in MS instrumentation (LC-MS/MS, GC-MS, MALDI-MS, Orbitrap and IMS) within a range of complex matrices (peptides, lipids, protein) and small molecules. Expert knowledge in sample preparation for identification and quantification of small and large molecules such as LLE, SPE, SPME, DLLME, ultrasonic extraction and QuEChERS. Wide and deep expertise in analytical method development and method validation based on FDA and ICH guidelines, and in working understanding of quality systems such as GMP and/or GLP. Known for unique and creative solutions to analytical challenges, delivering game changing strategies. 20+ works presented at national and international conferences and 11 scientific papers published.
Asger W. Nørgaard has a long background in experimental analytical chemistry with mass spectrometry (MS) as his speciality. Upon completion of his master’s degree, he worked in public research for 10 years. His research was focused on MS characterisation of occupational exposures, including fragrances, cleaning and coating products, biocides, jet engine exhaust and nano materials. At Novo Nordisk, Asger has worked with Extractables and Leachables (E&L) and general analytical support since 2016. Main work areas are E&L with focus of production utensils, ad hoc identification of unknowns by MS in addition to analytical method development.
Tim Petermann graduated as Food Chemist in 2012 at the University of Würzburg and in 2013 graduated as a State Certified Food Chemist at the Landesamt für Gesundheit und Lebensmittelsicherheit Bayern (State Office for Health and Food Safety Bavaria). From 2013-2017 he was Study Director and HPLC Systems’ Owner for a Contract Laboratory in the field of food supplements, dietetic food, pharmaceuticals and water. In 2017 he joined NAMSA Obernburg as Study Director with responsibility for UPLC-MS in the field of chemical characterization and E&L Studies of Medical Devices, and in 2021 became Principal Chemist with responsibility for technical and scientific questions and projects.
