Smithers has accumulated more than four decades of expertise in organising global events and curating enlightening and informative conferences that offer valuable networking prospects.
Attended by CEO's, senior principal scientists, researchers, presidents, chemistry directors, lecturers, R&D managers and pharmacologists to name a few.
The event spans over two days and includes a series of presentations on industry insights and collaborative discussions, making it an indispensable gathering for professionals working within the industry.
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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.
Dr. Alina Martirosyan is experienced in non-clinical evaluation of medical devices and pharmaceuticals, and is a Biocompatibility subject matter expert at B. Braun Melsungen AG (Germany). As part of the biological risk assessment of medical devices she is planning, coordinating and managing the biocompatibility studies, performs toxicological evaluation and risk assessment of chemical constituents, dealing with notified bodies and national agencies. She holds a PhD degree in Biochemistry, is a European Registered Toxicologist (ERT), Delegate of American Board of Toxicology (DABT), and is acting as an expert in ISO/TC 194 for the ‘Biological and clinical evaluation of medical devices’.
Graduated in 2010 in Veterinary Medicine at the University of Padua, Margherita Monico has also obtained a Master’s degree in Biotechnology for Business at CUOA Business School.
In Mérieux NutriSciences since 2019, Margherita is one of the Science Center Project Managers dedicated to designing and supervising Extractables & Leachables studies, and also provides customized courses and webinars on the subject.
Dr. Roberto Menzel graduated from FSU University Jena and holds a Ph.D. in Chemistry. He started his career as an assistant editor in the natural science book section at Wiley followed by a position as group leader for the organic trace analysis in the environmental analytical division at Eurofins Scientific. In 2015, he joined Sartorius Stedim Biotech where he is heading the internal analytical laboratory and Extractables group. The main working areas are material and product qualification studies for single-use (SU) systems and components for the biopharmaceutical industry. He authored several articles on the characterization of plastics and SU devices regarding extractable compounds.
Mohinish Sahai, PhD, MBA, is a Group Leader for Extractable and Leachables within PPD (Part of Thermo Fisher scienfic) at Athlone, Ireland. He has about 16 years of experience in the pharmaceucal industry from various roles within Analycal method development, validaons , Extractable and Leachables. In the following years he had developed his experse parcularly in Extractables and Leachables(E&L), Nitrosamine tesng and genotoxic impuries evaluaons. At PPD, Athlone Ireland site , he leads the E&L group and work extensively on E&L studies for Parenteral products, Manufacturing process components assessment, OINDP’s and other inhalaon and different formulaons CCS.
He holds a Doctorate in chemistry and a master’s degree in management. He is a Black belt in Lean Six Sigma.
Candice Johnson, Ph.D. is a Senior Research Scientist at Instem. Dr. Johnson has co-authored several peer-reviewed publications and book chapters describing the implementation of in silico approaches and methodologies for gaining confidence in in silico predictions. Her work expands into novel application of in silico approaches and supporting the advancement of alternative methods. She is particularly interested in the application of computational tools to support toxicological evaluations; for example, in the assessment of extractables and leachables.
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.
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.
Ron Brown is a toxicologist with 35 years of experience in regulatory toxicology and risk assessment. He recently retired from the US FDA after 25 years of service and currently directs a small company, Risk Science Consortium, LLC, that provides consultation and training in toxicological risk assessment and computational toxicology. At the FDA, Ron was the senior toxicologist responsible for developing and reviewing toxicological risk assessments of extractable and leachable (E&L) compounds from medical devices. Prior to his position at the US FDA, Ron served as a Senior Associate at the ILSI Risk Science Institute. He is founding member and former President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology and former President of the Dose-Response Specialty Section of the Society for Risk Analysis.
Born: 10.09.1981 in Piekary Śląskie, Poland
Alicja is currently employed at the Octapharma where she is responsible for material qualification at corporate level including chemical safety assessment of polymerc processing, packaging, and administration materials and the planning and supervision of extractables and leachables studies.
Prior to joining Octapharma, Alicja had a tenured position as a researcher at the French National Institute for Agricultural Research (INRA) where she investigated various possibilities to increase sustainability in the food processing industry. Alicja has compelled broad experience in material and polymer science and technology at the Institute for Composite Materials (IVW) in Kaiserslautern as well as at the Centre for Neutron Science (JCNS) and at the Institute for Nuclear Waste Disposal and Nuclear Safety (IEK-6) at the Research Centre in Jülich, Germany.
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 owns five state-of-the-art production facilities in Austria, France, Germany, Mexico and Sweden. For more information visit www.octapharma.com.
