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 8-10 September 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.
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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.
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.
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.
Baiba Cabovska currently is a Senior Manager in Chemical Materials Business Operations for Waters Technologies based in Milford, MA. She is responsible for customer collaborations and addressing customer needs in materials characterization with a special focus on extractables and migration testing.
Prior to joining Waters, Baiba worked at Mannkind Corporation doing analytical development for insulin based products as well as extractables testing for a dry powder inhalation device.
Kathy joined BD as R&D manager of Analytical Chemistry Lab. She is responsible for Extractable& Leachable research for pre-filled syringe products and medical device; YBB test and materials identification to support internal partner and external customer.
Prior to joining BD, Kathy worked at Baxter R&D centre. She worked for new packaging material development and doing extractable and leachable research for them. Kathy received Ph.D. in Physical Chemistry from Institute of Chemistry, Chinese Academy of Sciences, Beijing.
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".
He is the Director of Chemistry department at Shandong Quality Inspection Center For Medical Devices . He has 12 years research experience in medical device and drug packaging evaluation. He is Committee member of National Standardization Technical Committee on Infusion equipmen. He also sits in ISO/TC194 (Medical Device Biological Evaluation) and ISO/TC76 (Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use) working group.
Weichun Yang, is currently the Director of ADQC department at STA Pharmaceutical Co., and led a group of scientists to provide analytical service support. Prior to STA, Weichun was Sr. Manager at Baxter Suzhou R&D Center and held various positions for several organizations. Weichun has over 20 years of analytical chemistry experience in the pharmaceutical, environmental, food/feed, and chemical industries. Authored over 30 publications in related areas and participated in several books preparation. Weichun received his Ph. D. from Brigham Young University.
Mr. Hovery Yin got his master degree from East China University of Science and Technology with major in Analytical Chemistry, had 8 years of analytical R&D experiences in biopharma industry. He is currently the Extractables/Leachables Project Specialist in Sartorius Validation Services department. 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 Convention as Analytical Scientist to develop analytical methods for Pharmacopoeia monograph and then had role as Technical Manager of Extractables & Leachables in NSF International.
Coming soon...
Queenie Gai received her M.S. in Analytical Chemistry from East China University of Science and Technology. With more than 7 years E&L experience, she now serves as global E&L Senior Consultant of Merck BioReliance Validation Services (BVS) Laboratory. BioReliance Validation Services supports Merck’s overall strategy and execution of E&L studies for the development and application of Single Use System. Her experiences include method validation, designing of custom testing and interpreting industry and regulatory guidance.
Andrew Teasdale PhD has over 25 years’ experience in the pharmaceutical industry as an analytical chemist and within quality assurance and regulatory roles. In his current role he chairs AstraZeneca’s Impurity Advisory Group. Dr Teasdale has published a number of papers relating to extractables and leachables, mutagenic impurities and other impurity related matters. He is currently the chair of the Extractables and Leachables safety Information exchange (ELSIE) and also led a number of industry expert groups; these include both safety and quality groups within Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), Product Quality Research Institute (PQRI) . Andrew has also represented EFPIA in both ICH Q3C and Q3D Expert working groups and the newly established ICH Q3E EWG relating to Extractables and Leachables. He has also advanced a number of key scientific advancements in the control of impurities as the inventor of the purge factor concept and the instigator of the development of Elemental Impurities database for excipients. With over 50 scientific papers, he has also written 2 books:
Genotoxic Impurities – Strategies for Identification and control. Editor A Teasdale. Publisher Wiley. ISBN 978-0-470-49919-1
ICH Quality Guidelines – An Implementation Guide. Editors A Teasdale, D Elder, R W Nims. Publisher Wiley. ISBN 978-1-118-97111-6.
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.
