No.3555 Qixin Road, Minhang District, Shanghai 201101, P.R.China
E&L China 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
The Fourth Extractables & Leachables China 2021 will return to Shanghai, China on 23-24 November 2021 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.
Mr. Yang Xiaojun joined Shanghai WEIPU Chemical Technology Service Co., Ltd. in 2018 as the technical director of compatibility study, responsible for the operation of the compatibility study team. He has been in the field of compatibility research since the first guideline for compatibility of plastic packaging materials were issued in 2012. In the past ten years, he wasdedicated to the compatibility study of various in-process components, packaging materials and drug delivery devices in the whole life cycle of drugs, with more than 1000 compatibility project application experience. In addition, he has participated in the drafting of guiding principles for compatibility study of chemicals drugs and elastomers. He has unique experience and skills in the field of compatibility and can provide customized compatibility study solutions for customers.
Wenjing Zhao is the chemistry scientist of Medtronic Technology Center in Greater China. She is responsible for the Chemical Characterization work for the whole MTC medical devices. She graduated from Soochow University and had been engaged in the research and development of Pharmaceutical Chemistry and medical device for 10 years. She is good at chemical synthesis, chemical analysis and chemical characterization, and she is also familiar with Macromolecular chemistry.
Lin Chunxin has over 8 years of E&L project operation experience, handling more than 1000 varieties of E&L projects. He is familiar with domestic and overseas regulations, and has accumulated extractables and leachables research skills.
Lee M. Nagao, Ph.D., is a Senior Director of Science, Regulation and Policy at the law firm of Faegre, Drinker, Biddle and Reath, LLP, and is a member of the Firm’s Life Sciences Consortium Management and Regulatory Affairs Practice Group. The Group works extensively with pharmaceutical, biopharmaceutical and medical device companies on a range of scientific and regulatory collaborations and provides strategic and regulatory guidance to individual life sciences companies. Lee plays a lead role serving scientific and regulatory consortia including the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS), the Extractables and Leachables Safety Information Exchange (ELSIE), and the International Pharmaceutical Consortium on Innovation and Quality (IQ). Lee has extensively published and presented on many aspects of pharmaceutical development including supply chain, CMC, and translational sciences. She has represented various industry groups before regulatory and scientific agencies and organizations in the US, Europe and Asia, including the FDA, EMA, China NIFDC, Chinese Pharmacopoeia, ANVISA, Taiwan CDE, Japan PMDA, and USP.
Qian Kejun is a senior application chemist in Waters. With over 15 years of experience in LC and MS, she helped many customers set up standard methods. She has led teams members helping customers to build E&L library and develop E&L analysis workflow. Kejun has introduced UNIFI E&L workflow for many customers.
Wei holds a master degree in Cell Biology from Peking Union Medical School and a Ph.D degree in Toxicology from University of Kentucky.
She joined Medtronic in 2017 and currently is a Principal Scientist at Medtronic Technology Center in Shanghai, China. This role focuses on the biocompatibility evaluation for medical devices and materials across multiple Medtronic’s business units for purposes of product registration and safety assurance.
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”.
Carol manages the the team of E&L study and toxicological risk assessment in Shanghai Henlius Biotech. Obtained Ph.D. in Analytical Chemistry from Chinese Academic of Science, she has over 10 years’ experience on method development, small molecular identification, pharmaceuticals & polymer Characterization.
Coming soon...
Weipu is a large research-based testing agency in China dedicated to laboratory technology services.
Weipu is founded in 2008, and the headquarter is located in Shanghai. Weipu has established (subsidiary) branch companies and offices in Guangzhou, Suzhou, Hangzhou, Qingdao, Chengdu, Jiaxing, Shenzhen, Beijing, Nanjing, Ningbo, Wuhan, Jinan and Changsha, and has set up specialized laboratories of various fields including chemistry,mate rials, mechanical physic, reliability, food, environment, medicine, biochemistry, and cosmetic efficiacy evaluation.
Weipu have qualifications (CMA and CNAS) approved and authorized by the state, and is recognized as national exemplary public service platform for small and medium-sized enterprises, academician expert workstation and high-tech enterprise.
Bio-pharmaceutical area:
Compatibility research of medicine contact materials and drug with packaging, packaging and sealing integrity research;
Genetic toxicity, residual solvents and medicine impurities analysis and testing;
Chemical medicine characterization, structure confirmation, excipients inspection, microorganism testing;
Original drug reverse engineering research;
Biological macromolecular structure confirmation and analysis;
Medical devices: Research and development of material testing, chemical characterization, leachate research, toxicology risk assessment, in vitro degradation experiments, animal experiments.
No.3555 Qixin Road, Minhang District, Shanghai 201101, P.R.China