2020 International Symposium on Quality Analysis of Biotechnology Drugs

Shanghai New International Expo Center
  • 2020 International Biomedical Quality Analysis Forum

Time Topic Guest
Time Topic Guest

Time TopicWelcome Speech Guest

Wang Yan Chief Pharmacist
Director of Shanghai Institute for Food and Drug Control

Time TopicQuality Research and International Development of Traditional Chinese Medicine Guest

Dr. Guo De-an , Professor
Director of National Engineering Laboratory for TCM Standardization Technology;/Director of Shanghai Research Center for TCM Modernization; Professor of Shanghai/Institute of Materia Medica, Chinese Academy of Sciences

Time TopicQuality Requirements for Herbal Medicine in Europe Guest

Dr. Rudolf Bauer ,Professor
Head of The Institute of Pharmaceutical Sciences at University of Graz

Time TopicStudy on The Critical Quality Attributes in The Development of Generic Advanced Injections Guest

Zhang Xinxin, Professor
Professor of Shanghai Institute of Materia Medica, Chinese Academy of Sciences

Time TopicControl of Elemental Impurities Guest

Time TopicTBD Guest

Time Topic Guest

Time TopicUSP Biologics: Strategic Updates and Performance Standards Application Guest

Zou Tie, PhD
Senior SCD Manager, Biologics, USP China

Time TopicAutomation, Robotics and Digitalization in Biopharmaceutical QC Labs Guest

Boris Zimmermann, PhD
Head of Product Analytical Science, Global Analytical Science and Technology (GASAT), Roche

Time TopicConstruction and Prospection of China Pharmaceutical Microbial Control System Guest

Hu Chang-qin , Research Fellow
Chief Chemicals Expert of National Institutes for Food and Drug Control

Time TopicTBD Guest

Geert Verdonk
Director Global Center of Expertise Microbiology Merck /MSD

Time TopicAnalysis of Microbiological Contamination for Sterile Pharmaceutical Production Processes Guest

Yang Meicheng Chief Pharmacist
Deputy Director of Shanghai Institute for Food and Drug Control

Time TopicThe Importance & Challenge of Trace Analysis in Cosmetic --- L’Oreal Practice & ISO Standard Trend Guest

Maryline Gasthuys, PhD
Maryline Gasthuys,, PhD

Time TopicStudy on Quality and Safety Control Technology of Cosmetics Guest

Wang Ke, Chief Pharmacist
Deputy Director of Shanghai Institute for Food and Drug Control

  • Rudolf Bauer

    Professor Dr. Rudolf Bauer studied pharmacy 1976-1980 at the University of Munich; 1984 graduation as Ph.D. at the Institute of Pharmaceutical Biology, University of Munich, under the supervision of Prof. Dr. H. Wagner; 1993-2002 Associate Professor at the Institute of Pharmaceutical Biology, University of Düsseldorf; since 2002 he is full professor of pharmacognosy at University of Graz, Austria, and since 2004 he is Head of the Institute of Pharmaceutical Sciences at University of Graz. He has long experience in natural product chemistry, analysis and the bioassay-guided isolation of constituents from medicinal plants. He has published 315 research papers. For six years he has been president of the Society for Medicinal Plant and Natural Product Research (GA). Currently he is Editor of Planta Medica and Associate Editor in Chief of the Chinese Journal of Natural Medicines. Prof Bauer has been active in the development methods for quality control of Chinese herbs for more than 20 years. He is member of the expert group 13A and of the working group on TCM of the European Pharmacopoeia Commission; he is actively involved in the development of monographs of Chinese herbs for the European Pharmacopoeia; he is also member of the Traditional Asian Medicine Advisory Board of the Austrian Minister of Health. Together with Professor Litscher (Medical University of Graz) he is heading the TCM Research Center Graz. Recently he has been elected the founding president of GP-TCM Research Association.

  • Dr. Tie Zou is senior SCD manager of USP-China. He is responsible to USP biologics standards and analytical technologies introduction in the Great China region. He received his Ph.D. in Fudan University and completed postdoc training in Umass Medical School.
    With over 10 years of pharmaceutical industry experience, Dr. Zou has a broad array of scientific expertise in early discovery, identification/validation and bio-analysis process about recombinant mAbs, cell/gene therapy and peptides. He is with in-depth knowledge of USP and development of reference standards relevant to biologics products.

  • Boris holds PhD Physical Chemistry. He has worked 15+ years with Roche/Genentech in Germany and North America. He has worked in various QC functions, including QC lab operation, test methods, method validation, QC technologies, late-stage analytical development, control systems and CMC regulatory submissions, post-marketing changes incl. HA interactions. He held leadership positions in QC operations and global QC. As Head of Product Analytical Science,he is accountability and strategic responsibility for enhanced product-scientific, analytical, bioassay and stability expertise for QC operations as well as launch and post-marketing cmc regulatory submissions. Analytical innovation and product specific technologies for QC network.

  • Maryline Gasthuys graduated her Ph.D in Mass Spectrometry in 2005 at the University of Paris. She then started working at L’Oréal as a technical manager on traces analysis by LC-MS. After several years of analytical laboratory management, she is now head of L’Oréal international network on analysis of traces and impurities and analytical chemistry quality manager. As part of the ISO working group on Analytical Methods in Cosmetics, she is the project leader for two standards currently under development on heavy metals and mercury traces determination.

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