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E&L Asia has well gathered E&L experts from home and abroad to discuss E&L regulations and technical issues, which can effectively improve the knowledge of domestic biopharma company on E&L and improve the technical level of relevant research institutions. - Sartorius
Extractables & Leachables Asia 2024 will be located in Shanghai, China on 19-20 November 2024 and explore the latest technological advancements, regulatory updates, progress in analysis of new materials for pharmaceutical packaging, new developments in medical & drug device combination products and much more! This event will deliver high level insight into the market and global regulatory landscape, while allowing extensive time for debate and networking.
Dr. Dennis Jenke is a Baxter Distinguished Scientist in the Technology Resources Division of the Baxter Healthcare Corporation. In this role, he works with a team of analytical chemistry professionals whose primary responsibility includes the development, validation and application of diverse analytical strategies and methods for the discovery, identification and quantification of trace constituents in pharmaceutically relevant solutions and samples.
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.
Mr. Hovery Yin holds master’s degree of analytical chemistry from East China University of Science and Technology, has nearly 10 years of analytical R&D experience in biopharma industry. Familiar with the global regulations and technical guidance of E&L study, has rich practical experience in E&L study which has completed hundreds of drug packaging, process plastic components and medical device E&L projects. He has participated in several times of NMPA on-site audit, familiar with the quality requirements of the laboratory management system.
He is currently the E&L Project Manager in Sartorius Confidence® Validation Services. He is responsible for technical support of validation and project management for Single-Use System (SUS). Prior to Sartorius, he worked for United States Pharmacopeia as Scientist to develop analytical methods for pharmacopoeia standards and then had role as Technical Manager of Extractables & Leachables in NSF International.
Wenjing Zhao is a biological technical manager in Fresenius Medical Care and has the responsibility for biocompatibility and chemical characterization of medical device, as well as the compatibility of drug-packaging materials. She worked in Medtronic as senior scientist in charge of medical devices of Chemical Characterization and Materials of Concern for 7 years. Wenjing graduated from Soochow University and had been engaged in the research and development of Pharmaceutical Chemistry and Medical Device for over 12 years. She is good at Medical Device Chemical Characterization, Materials of Concern, and Polymer science.
Yang Chao, the Biological Evaluation Senior Engineer at the Product Safety Department in Mindray, is responsible for the biocompatibility evaluation of the company's Endoscope Instruments and the verification research of reusable instruments' reprocessing. He is also responsible for the test and verification of the ISO18562 series(PM、VOCs and E&L) for the gas monitoring module of the monitor. With 15 years of experience in testing and verification in the medical device industry, Yang is a Reviewer in the biomedical field of Shenzhen Science and Technology Innovation Comm as well. Prior to Mindray, he worked at the Beijing Institute of Medical Device Testing, with the title of senior engineer.
Dongdi Sun is the director of chemistry lab which mainly provides customized chemistry testing services, including chemical characterization of medical devices materials, drug packaging materials compatibility study, target compounds method development & validation and testing. Dongdi Sun obtained Ph.D. in chemistry from Mississippi State University in the United States. He has 11 years’ research experience in analytical chemistry including 5 years of research experience in chemical characterization of medical devices and drug packaging material compatibility study. In 2019, he won the honorary titles of "doctor of entrepreneurship and innovation of Jiangsu Province" and "high level talents of science and technology innovation and entrepreneurship of Soochow".
Dr. Dennis Jenke is a Baxter Distinguished Scientist in the Technology Resources Division of the Baxter Healthcare Corporation. In this role, he works with a team of analytical chemistry professionals whose primary responsibility includes the development, validation and application of diverse analytical strategies and methods for the discovery, identification and quantification of trace constituents in pharmaceutically relevant solutions and samples.
Berk Oktem is a Chemist and Toxicologist at US FDA’s Center for Devices and Radiological Health, Office of Orthopedic Devices. He serves as a lead or technical expert for pre-market reviews and conducted research focused on extractables, leachables analysis, small molecule identification and analysis, polymer degradation and proteomics for more than 20 years. He received his Ph.D. in Analytical Chemistry from the University of Delaware, performed post-doctoral research at Johns Hopkins School of Medicine and also spent 10 years in private sector as research and applications scientist in product development of chemical analysis systems prior to joining FDA.
Xiaoxia Ye is the manager of trace impurity investigation lab at Huadong Medicine. She is responsible for E/L and trace-impurity-related studies for pharmaceutical products. Xiaoxia Ye obtained Ph.D. degree from University of Alberta and has more than 15 years’ experience in chemical characterization using mass spectrometry.
Wenjing Zhao is a biological technical manager in Fresenius Medical Care and has the responsibility for biocompatibility and chemical characterization of medical device, as well as the compatibility of drug-packaging materials. She worked in Medtronic as senior scientist in charge of medical devices of Chemical Characterization and Materials of Concern for 7 years. Wenjing graduated from Soochow University and had been engaged in the research and development of Pharmaceutical Chemistry and Medical Device for over 12 years. She is good at Medical Device Chemical Characterization, Materials of Concern, and Polymer science.
Armin has held the role of Principal Scientist at Sartorius Stedim Biotech GmbH in R&D and PD since 2016. After his PhD, he started his career in the R&D department of Ciba-Geigy in 1995. During his time at Ciba, Novartis, and Ciba Specialty Chemicals, he was head of laboratories for organic trace-analysis, GLP & GMP analytics, where he was responsible for impurity profiling, migration studies, E&L investigations, development of GMP quality control methods, and stability testing. After 2010 he worked as a consultant and Qualified Person (QP) for Intertek in Switzerland.
Armin is a lecturer and trainer in E&L at conferences and seminars and is a member of various industry consortia (BPSA, BPOG, DECHEMA, MIT BioMan). Since this year, he has been the nominated Chairperson of the Pharmacopeia expert group 16 in the European Directorate for Quality of Medicine (EDQM).
Fu Peilin, R&D center director, Shenyang Sinqi Pharmaceutical Co.,Ltd., Ph.D of pharmaceutical analysis, Shenyang Pharmaceutical University; Master’s supervisor, China Medical University; Pharmaceutical analysis expert, China Medicine Education Association; China youth May 4th Medal; Person in charge of public platform for science and technology services of "compatibility of pharmaceutical products and packaging research", Shenyang Bureau of Science and Technology; Specializing in the compatibility of pharmaceutical products and packaging materials; Co-edited the first book in China — “Theory and Practice of Compatibility of Pharmaceutical Products and Packaging”.
