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.
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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Supported by:
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.
Carsten Worsøe is a research scientist in an analytical development department at Novo Nordisk. In over 18 years at Novo Nordisk, his main responsibility has been to develop analytical methods for L&E test procedures of new packaging/container closure systems under development. Within Novo Nordisk Carsten has been one of the main actors to bring relevant people in packaging materials, toxicology, formulation, regulatory and analytical together to perform risk assessments and strategies for L&E testing in development projects.
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.
Markus Obkircher is Director R&D heading Merck’s Reference Materials and Proficiency Testing division with teams in the US and Switzerland. He is responsible for the in-house development of new analytical standards and certified reference materials under ISO/IEC 17025 and ISO 17034 double accreditation with a strong focus on quantitative NMR. Prior to this position he was R&D Manager in Buchs, Switzerland, with a strong focus on synthesis, characterization and certification of reference materials. He joined Merck / Sigma-Aldrich eight years ago after heading the development unit for a custom API manufacturer. He completed his post-doctoral studies at Harvard in Boston and his PhD thesis in Basel, and further holds an executive MBA degree from the University of Zurich.
TBA
As an engineer from the Ecole Centrale Paris and having a PhD in Mechanics Thomas has broad technical skills related to chemistry and material science but also a good understanding of operational project management. Thomas joined FILAB in 2017 and is now in charge of FILAB's scientific and technical development, as well as managing the entire laboratory.