How attending this conference will benefit you:
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.
Martin Wåhlander is Senior Specialist of Materials and Coatings at Alfa Laval in Sweden. Since 2018, he has been working as the Subject Matter Expert in the Department of Single-Use Separators. Martin has a Ph.D. in Fibre and Polymer Science from the Royal Institute of Technology, Stockholm. Since 2008, he has been working and has collaborated globally with focus on polymeric materials, coatings and composites at Alfa Laval, ABB Corporate Research (Sweden), the University of Tokyo (Japan), the University of Manchester (UK), and Universität Duisburg-Essen (Germany). Martin has more than 10 peer-reviewed publications and is a member of the Royal Society of Chemistry (RSC).
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.
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.
Ms. Schaible is responsible for oversight and direction of WuXi AppTec’s Analytical Chemistry and Regulatory Toxicology departments based in St Paul, Minnesota supporting manufacturers of pharmaceuticals, medical devices and combination products. With over 30 years’ analytical experience and over 10 years specializing in international support for extractable and leachable studies, including Toxicological Risk Assessments and Safety Assessments, Sandi and her team have supported thousands of products. Ms. Schaible is also an international and U.S. delegate for TC 194, the technical committee for ISO 10993.
Armin is Principal Scientist at Sartorius BPS, supporting the E&L activities in R&D and PD. Before that he had various positions at Ciba, Ciba Speciality Chemicals and Intertek C&P, as lab head, consultant and qualified person (QP). Armin is lecturer and trainer in E&L conferences and seminars. He is member of the ELSIE- and BPOG-supplier group and delegate in the Pharmacopeia expert group 16 of the EDQM.
Smithers helps medical device and pharmaceutical product manufacturers bring innovative and highly effective products to market with world-class expertise and extensive, independent testing capabilities at accredited facilities in the UK and USA.
Our experienced team will provide advice, guidance and recommendations as well as delivering test data to help you demonstrate compliance to regulatory guidance or specifications set out by the FDA, EMA, MHRA, USP, ASTM and ISO.
We can assist throughout your medical device product development.
Services include:
E&L Europe continues to grow and is clearly the premier event of its type - Executive Partner, SCIO Analytical
