Edna I-Jen Hu
Founding Director of Quality Management System(QMS) Program, School of Life Science and Technology, Shanghaitech University, course teacher, senior consultant of LexaMed (GMP/ISO compliance). She graduated with an undergraduate degree in Food Science from Cornell University in 1986 and a master's degree in biology from Johns Hopkins University in 1994. Regulatory affairs consultant with expertise in microbiology. Over 25 years of quality assurance, regulatory affairs, R&D, personnel training, and manufacturing experience in the medical device, pharmaceutical, and food industries. Design and teach courses such as Quality 101 and Regulatory Requirements for Medical Devices (ISO 13485) .
Jin Dai
Executive Director of Quality Management System (QMS) Program, teaching associate professor, School of Life Science and Technology, ShanghaiTech University. Bachelor’s degree in Economics, Master and Doctor's degree in management from the School of Economics and Management of Tsinghua University. 2008-2009 visited the School of Economics, University of Magdeburg, Germany. Awarded German Chancellor's Scholar 2008-2009; In 2009, she was awarded the China Management Research Award jointly by Emerald Publishing Group and the International Association of Chinese Management Studies. Excellence Award in Shanghai University Teachers' Teaching Innovation Competition 2021. Co-authored with Luo Wei the textbook Lean Healthcare: How to Improve Patient Services, Medical Quality and Hospital Operation Efficiency. Design and teach courses such as Quality 101 and Leadership and Management Review.
Qi Wei
Associate Professor, Researcher, School of Life Science and Technology, ShanghaiTech University. She received Ph.D. from the University of Texas Southwestern Medical Center in 2006. Awarded the annual Alfred Gilman Award for Research Excellence (established by Nobel Laureate Dr. Alfred Gilman). Long-term commitment to the molecular biology and physiological pathology of chromatin modification, comprehensive use of chemical biology and gene editing methods, focusing on chromatin modification enzyme as the target of the pathological mechanism and innovative targeted drug development. The leading team has revealed the physiological and pathological mechanisms and functions of multiple chromatin modification machines in response to environmental changes in cells and in tumors and metabolic diseases. Design and teach courses such as Principles and Examples of Drug Research and Development and Laboratory Management and Practice.
Zhao Jian
Associate professor, researcher, Shanghai Institute for Advanced Immunochemical Studies (SIAIS), ShanghaiTech University. She graduated from the University of Heidelberg in 2004 with a Doctor of Science degree. Focus on the development of cell and gene therapy platforms and general technologies, research on new mechanisms of important signal transduction pathways in cell fate determination and the occurrence and development of neurodegenerative diseases, related new treatment strategies and new targets, and research and development of new drugs. She was selected as the top ten news of Basic research in China by the Ministry of Science and Technology, and won the first Prize of Shanghai Science and Technology Progress, the second prize of China Medical Award, and the second prize of China Medical Science and Technology Award. Design and teach courses such as Ethics of Biomedical Research and Laboratory Management and Experimental Design.
Robert Roy Reich
President of LexaMed USA. Microbiologist with over 40 years of experience in management, inspection, quality and regulatory matters in the healthcare industry. Extensive experience in pharmaceuticals and medical devices. He has served as co-chair of the HIMA Technical Committee for the review of packaging Validation and sterilization monographs and as a member of the working group that drafted guidelines for biological and chemical indicators, biometric load quantification, and microbial methods for assessing packaging integrity. He has served as co-Chair of the ANSI/AAMI Industrial EO Committee and as a member of the ISO/ANSI/AAMI Biological Indicators, Product EO Residues, Alternative Chemical Sterilizers, Packaging, Microbial Methods, and Aseptic Filling Technology Standards Committees. He served as a member of the PDA Working Group drafting guidelines on the validation of dry sterilization and depyrogen processes. Design and teach courses such as Regulatory Requirements for Medical Devices (ISO 13485) and Validation, Verification and Continual Improvements.
Gao Jian
Senior Learning Consultant, Siemens School of Management. Have perfect project management knowledge and rich practical experience, have a deep understanding of the logistics industry and many years of practical operation and management experience. He is Siemens Global Certified Project Manager, PMI American Project Management Institute Certified Project Manager PMP, NPMA/OPMA Organization Project Management Expert Certified OPME, ATD(American Talent Development Association) certified Instructor, TTI CPEQA Certified Emotional Intelligence Management Consultant. Training courses: Project management, advanced project management, project planning and sand table deduction, project management core management course, Leadership core management course, project management system construction, etc. He worked as project manager and logistics Manager of Siemens (China) Co., LTD. Design and teach the course Project Management.
Zhou Haotian
Assistant Professor, School of Entrepreneurship and Management, ShanghaiTech University. He received a bachelor's degree from the School of Life Sciences of Tsinghua University, a master's degree from the Institute of Psychology of the Chinese Academy of Sciences, a master's degree from the Department of Psychology of the University of Chicago, a doctorate degree from the Department of Psychology of the University of Chicago, and a postdoctoral degree from the University of Chicago Business School. He explores the underlying mechanisms of human cognition, emotion, and behavior, and their application to decision-making, marketing, and interpersonal relationships. Several papers have been published in international academic journals of psychology. Design and teach courses such as Risk, Improvement, and V&V (RIVV) and Innovation Science: Cognitive Principles and Market Applications.
Jiang Zhihao
Assistant Professor, researcher, School of Information Science and Technology, ShanghaiTech University. Bachelor's degree in measurement and control Technology and instrumentation from University of Electronic Science and Technology of China, Master's degree in robotics and Doctor's degree in Computer science from University of Pennsylvania. He joined the Toyota Information Technology Research Center in Silicon Valley as a researcher, engaged in model-based software development and verification in the field of intelligent medical instruments and connected vehicles. It is devoted to the theoretical and applied research of the human-machine-matter ternary fusion system. Design and teach courses such as Risk, Improvement, and V&V (RIVV) and Design and Verification of Intelligent Medical Instrument Software.
Xu Hao
Major projects manager, iHuman Institute, ShanghaiTech University. Doctor of Biomedical Engineering, Shanghai Jiao Tong University. Innovation in the Box, TRIZ Innovation expert, Lean Six Sigma Black Belt Master. He has 16 years of experience in multinational companies, including General Electric, Siemens, and Aerotek Investment. Design and teach the course Risk, Improvement, and V&V (RIVV).
Miao Weikai
Professor, Vice Dean, School of Software Engineering, East China Normal University. Bachelor of Engineering in Computer Science and Technology from Southeast University, Master of Engineering in Computer Software and Theory from Shanghai University, Doctor of Science from Software Engineering Laboratory of Hosei University, Japan. His research interests are software engineering, software formal methods, software testing. In 2014, he was selected into the Shanghai Science and Technology Commission Young Science and Technology Talents Sailing Program; In recent years, he has presided over 2 projects of the National Natural Science Foundation and many projects of important ministries and commissions. He has been teaching software engineering courses such as Software Requirements for a long time, and has won important teaching and research awards such as the first prize of the Third Shanghai University Young Teachers Teaching Competition in 2018, the Special Prize of Shanghai Science and Technology Progress in 2019, and the first Prize of Technology Invention of China Computer Society in 2021. Design and teach courseRisk, Improvement, and V&V (RIVV).
Han Jianchun
Management consultant of Medeca (Shanghai) Enterprise Management Consulting Service Center, founder of MEDICAFE. Reviewer of the National Quality Award (2017 to date), reviewer of the National field management star evaluation, special lecturer of the Human Resources Branch of the China Medical Device Association, special writer of the Medical Economic News, external expert of the consulting department of the China Quality Association, and a number of well-known medical device compliance consultants. Design and teach courses such as Risk, Improvement, and V&V (RIVV) and Regulatory Requirements for Medical Devices (ISO 13485) .
Wang Shumei
Vice President of Quality & Regulation, Shanghai United Imaging Healthcare Co., Ltd., LTD. More than 15 years of experience in quality & regulatory management, deep understanding and practical experience in quality management system construction, R&D quality management, production quality control, supplier quality management. Member of the Standard Committee of the National Medical Device Quality Management and General Requirements Standardization Technical Committee (SAC/TC221), member of the third National Medical Device Quality Management and General Requirements Standardization Technical Committee (SAC/TC221), Member of IEC TC62 /SC62B WG 53 Refurbishment of Medical Imaging Equipment, member of technical expert group on unique identification standard for medical devices, expert on technical review of information standard related to unique identification of medical devices. Design and teach the course Design and Development Control.
Chen Heng
Director of Quality Management Department, headquarters of Shanghai United Imaging Healthcare Co., Ltd. He has been engaged in quality management in the fields of mobile phone structural parts, magnetic resonance, communication sites and energy products, data centers, medical imaging products and medical information products, involving all stages of product life cycle such as product planning, concept, design, development and verification, confirmation, mass production and after-sales service. Familiar with ISO9001, ISO13485, TL9000 quality system, QSR 820 and other medical device regulatory requirements, had direct management of R&D quality assurance, production quality control, after-sales service quality assurance, and led the preparation of relevant process specifications and quality specifications. Design and teach the course Design and Development Control.
Gao Xin
Manager of International legal Affairs Department, Shanghai United Imaging Healthcare Co., Ltd. With more than 10 years of experience in the medical device industry, he has rich practice in the quality management of medical device products, involving all stages of the product life cycle such as product planning, concept, design, development and verification, confirmation, mass production and after-sales service. Familiar with the standards and testing of large-scale medical imaging products and the regulatory requirements of overseas countries, familiar with UDI regulations. Design and teach the course Design and Development Control.
Zhang Peiming
Associate Professor, the Belt and Road Medical Device Regulatory Science Research Institute, University of Shanghai for Science and Technology. Doctor of Optical Engineering, University of Shanghai for Science and Technology, long-term commitment to medical device regulatory science and ophthalmic equipment research. Member of the National Technical Committee for Standardization of Surgical Instruments (SAC/TC94), Researcher of the Key Laboratory of Respiratory Anesthesia Equipment of the State Food and Drug Administration, researcher of the Engineering Technology Research Center of Shanghai Interventional Medical Devices, external technical expert of TUV Medical Device Quality Management System certification in Germany, expert of the special fund project review of Shanghai Economic and Information Commission, He once held a temporary post in the Certification Evaluation Center of Shanghai Food and Drug Administration. Provide technical services to government regulatory departments and research institutions such as Shanghai Market Bureau, Shanghai Drug Administration, Henan Drug Administration, Hunan Drug Administration, Shanghai Health and Health Development Research Center, etc. Design and teach the course Regulatory Requirements for Medical Devices (ISO 13485) .
Luo Wei
Lean Medical Director of Lean Enterprise China (LEC), member of Lean Medical Committee of Global Lean Alliance (LGN), Certified consultant of Shingo Institute of Utah State University, founder of Shanghai Four Degrees Medical. I have helped establish the benchmark of lean management in Chinese hospitals, including Taizhou Hospital of Zhejiang Province and Guangdong Hospital of Traditional Chinese Medicine. Developed a series of lean medical courses, helped a number of hospital institutions to train more than 1,000 lean medical talents, guided the implementation of more than 300 improvement projects, and guided hospitals and departments to build a continuous improvement of lean management system and culture. Invited to speak at the Lean Medical Academic Conference at Stanford University. Translated several lean and medical books, such as Lean Transformation: Lean Practice Guide for Hospitals, Lean Mouth, etc. Co-authored with Professor Dai Jin the book Lean Healthcare: How to Improve Implement Lean in Chinese Hospitals, which is used as course material and hospital training material. Design and teach the course Lean Healthcare.
Song Xiaodong
CEO of UTC Therapeutics LTD., focused on developing cell drugs for tumor immunotherapy. He has worked in R&D, manufacturing, quality and registration departments at Pfizer and Johnson & Johnson for over 20 years. Directly involved in the development and registration of a number of new drugs, and obtained 8 new drug marketing approvals and more than 50 registered clinical approvals worldwide. He was Director of Global regulatory Registration at Johnson & Johnson, member of Johnson & Johnson's Asia-Pacific drug manufacturing leadership team, Chief scientist at Pfizer's Global Drug Development Center, and head of Pfizer's global generic drug patent infringement investigation department. During his term at Johnson & Johnson, he deeply participated in the cooperation project of Nanjing Legendary BCMA CART on behalf of Johnson & Johnson, and successfully obtained the first CART registered clinical approval document in China and the first registered clinical approval document of domestic CART drugs in the United States. On behalf of the State Food and Drug Administration, he joined the working group of ICH Pharmacopoeia Guiding Principles (ICH Q4) of the international coordination organization, and promoted the unification of technical standards between Chinese pharmacopoeia and European and American pharmacopoeia. At the invitation of the State Food and Drug Administration, I participated in the drafting of the GMP Appendix of Chinese cell therapy products and the technical guidelines for the associated review of apis and excipients. He has served as the chairman of RDPAC Pharmaceutical Council and the chairman of the Chinese Branch of the International Pharmaceutical Excipients Association. Design and teach the course Quality and Regulatory Requirements for Pharmaceuticals (for Human Use).
