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.
Principal Scientist Extractables and Leachablesat
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.
Technical Expert of Compatibility Researchat
Weipu biomedical R&D and laboratory services Technical expert of compatibility research
Ms. Chang graduated from Tongji University, focus on analysis and detection, with 8 years of experience in compatibility research of drug packaging materials, components and appliances, and elemental impurities. Ms. Chang is familiar with the guiding principles and regulatory requirements related to compatibility research at home and abroad, such as USP1663/1664、665/1665、PQRI、BPOG、ICHM7、ICHQ3、Four domestic compatibility guidelines and so on.
Ms. Chang participated in and was responsible for more than 2000 compatibility research projects, participated in and took charge of nearly 200 projects successfully declared at home and abroad, familiar with the technical requirements for review and approval at home and abroad, combining rich research strategy experience with advanced LCMSMS, GCMS, ICPMS and other technical platforms, service customers include Beisheng Research, Qilu Pharmaceutical, Yangzijiang Pharmaceutical, Changchun Biotech, Yichang Humanwell, Guilin Nanyao, etc
Manager of Project Management,Filtration/SUS, Confidence® Validation Servicesat
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.
Master of Analytical Chemistry, He has worked for a long time in the Provincial Institute of drug control and authoritative international third-party testing institutions; and deeply engaged in the field of pharmacy, materials and consumer goods testing for over 20 years, with experienced chromatography, mass spectrometry and spectral detection technologies. he is familiar with pharmaceuticals R&D, registration regulations and application requirements. At present, he is responsible for the compatibility research of drugs, packaging materials, production components, SUS and medical devices.
Medtronic Technology Center – Greater China
Wenjing Zhao is a senior scientist of Medtronic Technology Center in Greater China. She works in MTC as the chemistry SME and the MOC SME. She is responsible for Chemical Characterization and material safe work for the whole MTC projects. Wenjing graduated from Soochow University and had been engaged in the research and development of Pharmaceutical Chemistry and Medical Device for over 10 years. She is good at chemical synthesis and analysis, Polymer chemistry, and material chemical characterization.
Risk Science Consortium, LLC & US FDA(Retired)
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.
Director of Chemistry Laboratory, Medical Device Testing Centerat
WuXi AppTec (Suzhou) Co., Ltd
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".