Smithers E&L conference is the premier gathering of expertise in this field, I plan on attending every year - DABT Chemistry & Materials Scientist, Nelson Labs
Extractables and Leachables China is the first conference of its kind. Following on from the hugely successful E&L Europe and USA conferences, Smithers launched a brand new event focusing on extractables and leachables in China. The first event took place in September 2018 in Beijing and the second event took place in September 2019 in Shanghai.
This year Extractables & Leachables China will return to Shanghai, China on 8-10 December 2020 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 board-certified toxicologist who recently retired from the US FDA Center for Devices and Radiological Health. At FDA, his research efforts focused on the developing new methods to assess the risk posed by patient exposure to extractable and leachable compounds released from medical device materials. He is active in both domestic and international standards committees related to the biocompatibility of medical devices. Until recently, he served as the co-chair of the US TAG for TC194 (Biological Evaluation of Medical Devices) and as convener of ISO/TC194/WG11 (Allowable Limits for Leachable Substances). Ron is a founding member and former president of the Medical Device Specialty Section of the Society of Toxicology. He previously held leadership roles in the Society for Risk Analysis and the Association of Government Toxicologists. Prior to joining FDA, he was a Senior Associate at the ILSI Risk Science Institute in Washington, DC.
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".
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.
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.
Dr Guangming Wu graduated from department of Polymer Chemistry and Physicals in Zhejiang University in 2009, with extensive research area of rare-metal catalyst synthesis, characterization and application in polymerization. In 2009, he joined Shanghai Institute of Organic Chemistry as post-doc researcher to focus on the scale up and industrialization of first patented alpha-olefin catalysis with higher purity. After that in 2011, He joined SABIC as Scientist to develop high transparency Lexan product, PP and PE product, from lab formulation, compounding to application in customer side, several grades are developed and applied in LED application, medical packaging etc.; in 2014, he worked as Technical Leader to lead the peritoneal dialysis product development in China and Malaysia, pharma packaging is the major focus; In 2019, he joined SCHOTT P as Technical Customer Manager, responsible for glass packaging technology training to internal and external customers, customer service etc. 14 publications and 2 patents are published.
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.
Gyorgy Vas has over 20 years of experience in scientific research, product development, and laboratory management. Much of that time has been spent in a cGMP environment, where he has provided his expertise to solve problems related to finished pharmaceutical products and medical devices.
In his current position, he advises on regulatory filing strategies for multiple clients, and his group provides solutions for mitigating deficiency letters. Gyorgy led the implementation of state-of-the-art solventless sample preparation techniques into the cGMP laboratory processes, and is one of the few in this field with expertise in method development and validation for ultratrace (parts-per-trillion) level impurities in finished pharmaceutical products and medical devices.
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.
