Smithers has accumulated more than four decades of expertise in organising global events and curating enlightening and informative conferences that offer valuable networking prospects. With speakers from distinguished companies like Element, GSK Vaccines, Aptar Pharma, Octapharma, Sartorius Stedim Biotech and numerous others, the agenda is bursting with insights, helping the 2023 E&L Europe conference be the most exceptional one to date.
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.
Sessions include:
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Supported by:
Ramarao Gollapalli is a highly accomplished professional in the pharmaceutical industry, specializing in research and development with expertise in analytical sciences and extractables and leachables. With a strong educational background and extensive experience in the field, Ramarao has made significant contributions to advancing pharmaceutical sciences and ensuring product safety and quality. He holds a master’s degree in chemistry, which has provided a solid foundation for their career in the pharmaceutical industry. His expertise in extractables and leachables, a critical aspect of drug development and regulatory compliance, has been instrumental in evaluating and characterizing the potential interactions between pharmaceutical products and their packaging materials. Over the course of his career, Ramarao has successfully designed and executed numerous analytical studies to identify and quantify extractable and leachable substances, ensuring the safety and efficacy of pharmaceutical products.
He remains committed to professional growth and development, actively participating in industry conferences, seminars, and workshops. He also contributes to the advancement of the pharmaceutical sciences through publications and presentations, sharing their knowledge and insights with peers and the wider scientific community.
Nick is a Principal Scientist at Element Materials Technology responsible for providing technical support to new and existing pharma, med device and consumer products customers in the field of extractables and leachables. He has over 15 years of experience in the field of extractables and leachables, both in large pharma and at a CRO. Nick’s area of expertise includes E&L study design, defining E&L strategies, performing leachable risk assessments and authoring E&L regulatory sections. Nick is the Extractables and Leachable expert on the British Standards Institute (BSI) and European Standards Committee (CEN) for electronic cigarettes & E-liquids. Nick has presented on a number of different E&L related topics internationally and has developed and run pre-conference workshops on E&L assessment at a number of international conferences.
Prior to joining Element Materials Technology, Nick spent over 10 years at GSK in the field of extractables and leachables. During this time, he worked on a range of therapeutic areas including inhalation, topical and parenteral. Where he had responsibility for the E&L assessment of devices, closure systems and manufacturing processes to ensure patient safety, product quality and regulatory approval.
Dr. Ehman is the Director of Regulatory Toxicology at WuXi AppTec Medical Device Testing, with a focus on medical device and combination products. Dr. Ehman has over 20 years of toxicology and medical device experience, with expertise in toxicological risk assessments for medical devices, food and beverage products, and electronic nicotine delivery systems. Prior to joining WuXi AppTec Medical Device Testing, she worked as a toxicologist for RTI International, Toxicology Regulatory Services, and Altria Client Services. She holds a B.Sc. degree in Biology from Seton Hill University and a Ph.D. in Parasitology from McGill University.
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.
Alfred works in Cytiva’s extractables and leachables lab focused on testing polymeric materials and components used in the manufacturing of biopharmaceutical drug substances and products. He has a special interest in LC-MS and identification of unknowns, using high resolving mass spetrometry. Alfred is a Pharmacist and holds a PhD in Pharmaceutical Science, Analytical Pharmaceutical Chemistry from Uppsala University.
Noemí is Senior Research Scientist in the National Institute for Bioprocessing Research and Training (NIBRT) and is currently leading the ‘Process Insights’ Research Area in the Characterisation and Comparability Laboratory. She is an Analytical chemist with a wide background in the determination of pharmaceuticals, endocrine disruptors and emerging contaminants in environmental and biological matrices.
Currently, she leads E&L projects, related to the generation and monitoring of E&L during upstream stages, but also investigation of removal mechanisms during downstream steps, as well as she has already begun investigation to assess effects of leachables and the evaluation of the quality of single-use systems in cell and gene therapy manufacturing. Noemí is also involved in the investigation of Process Analytical Technologies for the monitoring of critical quality attributes of recombinant proteins, being dedicated to projects related to the development of on-line automated process control monitoring systems for multiple critical quality attributes continuous product characterisation, using high resolution LC-MS techniques for increased process understanding, optimisation, intensification and control.
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.
