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.
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.
Senior Technical Directorat
WEIPU Medical Devices Division
Member of the expert database of the Medical Device Branch of China Association for the Promotion of Quality and Safety of Food and Drug Enterprises
Member of the expert database of Suzhou Medical Device Industry Association
Mr. Wang Heng is currently the senior technical director of WEIPU Medical Devices Division, a member of the first batch of expert databases of the Medical Devices Branch of the China Food and Drug Enterprise Quality and Safety Promotion Association, and a member of the expert database of the Suzhou Medical Device Industry Association. He led the establishment of the million-level spectral database. He has extensive practical project experience in chemical characterization of medical devices, drug compatibility studies, in vitro degradation tests, and various physical and chemical property testing.
The laboratory team he leads has served more than 1,000 medical device manufacturers, the vast majority of which are high-risk medical device manufacturers. Assisted in the successful completion of NMPA , FDA and CE registration applications for a variety of high-risk medical devices such as orthopedic implants, cardiovascular implants, neurosurgery interventional devices, ophthalmic implants, blood purification consumables, and infusion equipment.
Biocompatibility Technical Managerat
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.
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".
Cheney has over 10 years of CRO business experience and over 8 years of Extractables and Leachables study expertise.
Cheney has Master's degree in biopharmaceuticals, and he is one of the drafters of the technical part of the China CDE’s Extractables and Leachables study gudiance "Technical Guidelines for the Study of the Compatibility of Chemical drugs and Elastomer Seals (Trial)" and has promoted the process of domestic research on the extractables and leachables study of in-process components. He has over 10 years of experience in third-party testing services and 8 years of packaging material E&L regulations and testing experience. He’s familiar with domestic and foreign drug-related laws, regulations and technical standards, master a variety of analytical technical equipment and testing methods; familiar with cGMP good practices, and help domestic companies submit files to regulatory authorities. In terms of E&L study of pharmaceutical packaging materials, he has handled over 1,500 projects, and has accumulated a wealth of extract and extract research skills.