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We are excited by the opportunities our new event platform provides to deliver you the same high-quality content, expert speakers and unique networking opportunities you have come to expect; all of which will now be available to access remotely from your home or office.
How attending this conference will benefit you:
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.
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.
Dr. Stults is Principal at C & M Technical Consulting, LLC, working with various local and global companies to advance the development of parenteral and inhalation products. Her primary area of focus is on device and packaging materials analysis and characterization for purposes of selection, qualification and control. She holds a Ph.D. in Analytical Chemistry from Michigan State University and a Masters in Management from Aquinas College. Prior positions include: Senior Fellow at Novartis Pharmaceuticals Corporation, Assistant Research Professor at San Francisco State University and Quality Associate at a Johnson & Johnson owned company. She was co-editor of the Leachables and Extractables Handbook (Wiley 2012) and has been a member of the Board of Directors for two consortia: Extractables and Leachables Safety Information Exchange (ELSIE) and International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS). She has been actively involved in the ELSIE Pilot Protocol Study and database development. She previously led IPAC-RS working groups to develop Materials Baseline Requirements for OINDP, a Leachables and Extractables Development Paradigm and a Chemical Risk Evaluation tool and has continued involvement as an IPAC-RS Science Advisor participating in global outreach and materials related initiatives. Dr. Stults is currently a USP Packaging and Distribution Expert Committee member contributing to development and revision of materials-related chapters.
Michael manages Smithers' Extractables and Leachables (E&L) and Chemical Analysis team in the UK. He has been working with E&L for over 15 years both for Biopharmaceuticals and Pharmaceuticals, and joined Smithers in 2009.
Michael has uses his expertise to solve the challenges of the assessment of E&Ls for Single Use System suppliers and users (bags, tubing, filters, connectors etc.) and final Container Closure Systems (pMDIs, stoppers, vials, pre-filled syringes, cartridges etc.). Michael’s team supports a diverse range of clients and industries requiring the support of analytical experts working within a cGMP and ISO17025:2017 environment.
Prior to joining Smithers, Michael worked in the validation department for one of the largest Single Use System suppliers and previous to that at a petrochemical organisation.
Michael has a BSc in Chemistry, and is a Member of the Royal society of Chemistry (MRSC).
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.
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.
E&L Europe continues to grow and is clearly the premier event of its type - Executive Partner, SCIO Analytical