2007年8月31日

• 非肠道制剂前期配方: 9:00 - 9:45 a.m.: Xie 博士 (美国)
• 蛋白质制剂配方的挑战: 9.45 - 10.30 a.m.: Gokarn 博士 (美国)

• 高温高压容器的湿热消毒灭菌: 10:45 - 11:30 p.m.: Pinto 教授 (巴西)
• 液体过滤除菌消毒: 11:30 - 12:15. p.m.: 董彦先生(中国)
• 高温蒸汽消毒杀菌的有效适用范围: 12:15 - 1:00 p.m.: Ruggierello博士 (意大利)

• 空气过滤除菌: 2:15 - 3:00 p.m.: 董彦先生 (中国)
• 活性药物辐射灭菌: 3:00 - 3:45 p.m.: Pinto 博士 (巴西)

• 单克隆抗体的开发: 4:15 - 5:00 p.m: Zeng 博士 (美国)
• 大规模生产: 5:00 - 5:45 p.m: Cherian 博士 (意大利)

2007年9月1日

• 疫苗和免疫治疗: 9:00 - 9:45 a.m.: Çiftci 博士 (美国)
• 非注射式疫苗接种在药物配方上的挑战: 9:45 - 10:30 a.m.: Liu 博士 (美国)

• 蛋白质-表面活性剂的相互作用: 10:45 - 11:30 a.m.: Cherian 博士 (意大利)
• 界面的生物纳米技术: 11:30 - 12:15 p.m.: Çiftci 博士 (美国)
• 防止假冒产药品: 12:15 - 1:00 p.m.: Liu 女士 (中国)

• 生物产品的前景: 2:00 - 2:45 p.m.: Nema 博士 (美国)
• 注射用水: 2:45-3:30 p.m.: Curto 工程师 (意大利)
• 稳定性的WHO指导原则 –修改稿: 3:30-4:15 p.m.: Saleh 教授 (埃及)

• GMP 无菌分装系统: 4:30 - 5:15 p.m.: Thomas 先生 (德国)
• HVAC 系统的认证: 5:15 - 6:00 p.m.: Curto 工程师 (意大利)

Dr. Eng. Paolo Curtò is Managing Director of DOC, a STILMAS Group Company specializing in Validation & cGMP Consulting for the Italian and International Pharmaceutical Industry. He has 20 years of international industrial experiences, working in US- FDA approved Pharmaceutical Manufacturing Companies, as Engineering & Validation Director, in Pharmaceutical Engineering Companies and in Pharmaceutical Equipment Suppliers Companies.

Paolo Curtò 工程师,STILMAS集团DOC公司管理经理(意大利)。

Dr. Kadriye Çiftci is Director of Drug Delivery at ICON Clinical Research. She has over 13 years of experience in academia and pharmaceutical R&D. Dr. Ciftci completed her training at University of Illinois at Chicago, Chicago, IL and University of Michigan Medical School in Ann Arbor, Michigan. She has held a Tenure Track Assistant Professor position at Temple University and a Research Fellow position at Schering Plough Research Institute. Her special interests include the development of drug delivery systems particularly biotech products and vaccines, gene therapy, and cancer research.

Kadriye Ciftci 博士,ICON临床研究药物传递部主任 (美国)。

Mr. Yan Dong is Senior Sales Manager of Pall Lifesciences BioPharm Division in China. He has been working in pharmaceutical and lifesciences fi eld for more than twelve years, including two years in new drug development, and 10 years sales and marketing in multinational companies. He holds a BSc degree of Beijing University in Chemical Engineering, and an MBA from Tsinghua University.

董彦先生,PALL生命科学药物公司高级销售经理(中国)。

Dr. Yatin Gokarn is Principal Scientist at Amgen, at Seattle, and leads a protein formulations group in the Pharmaceutics Department there. Yatin has an undergraduate degree in chemical engineering from University Institute of Chemical technology, Mumbai, India and MS and Ph.D. degrees in biochemistry from the University of New Hampshire. He has over 9 years experience in pharmaceutical industry, with tenures at Pharmacia / Pfi zer and Amgen.

Yatin Gokarn 博士,西雅图Amgen公司首席科学家 (美国)。

Dr. Jun Liu is a Senior Scientist at the Late Stage Pharmaceutical and Device Development Group at Genentech, Inc. He received his Ph.D. degree in Biochemistry from the University of New Hampshire. He has numerous scientifi c publications and presented nationally and internationally on the topics of protein formulation, stability and analytical characterization. He is currently leading a formulation group at Genentech that is responsible for development of protein formulation, drug delivery systems and biophysical characterization.

Jun Liu 博士,Genentech公司制剂和仪器开发部高级科学家(美国)。

Dr. Wen Liu was educated at Shanghai Medical University from where she received a Bachelor’s Degree in Medicine. Her educational training also includes WHO Continuing Education at Chinese Virology Institute in molecular biology, training for Quality Affairs by International Quality Directors, and several courses in GMP, Validations, Inspection and related topics. Currently she is the Site Manager for Quality Operations for Sanofi Pasteur in China.

Wen Liu 女士,Sanofi Pasteur公司质量运作部经理(中国)。

Dr. Sandeep Nema is Senior Director, Pfi zer Global Biologics in St. Louis where he is responsible for three functions – Preformulation, Formulation Development and Product Enhancement; and Microbiology. In this role he manages biologics a Pharmaceutical R&D portfolio of over 35 projects from discovery support, formulation development, scale-up, validation through BLA fi lings. Dr. Nema received his PhD in 1992 and since then has been involved in the development of small molecules and protein drugs via parenteral delivery, first at Mallinckrodt Medical and then at Pfi zer (Searle, Pharmacia). He has been lead formulator for four launched products.

Sandeep Nema 博士,Global Pfi zer Biologics公司高级主任 (美国)。

Prof. Dr. Terezinha de Jesus Andreoli Pinto is the Dean of the Faculdade de Cîências Farmacêuticas - Universidade de São Paulo (Brazil). Prof. Pinto coordinates CONFAR, a laboratory dedicated to the quality control of drugs, medicines, cosmetics and medical devices. She is president of the Council of Instituto de Pesquisas Farmacêuticas and has more than 25 years of industrial and academic experience. She is author of several books and book chapters and has authored 65 papers.

Terezinha de Jesus Andreoli Pinto 博士教授, São Paul o大学药学院院长(巴西)。

Dr. Giuseppe Ruggirello graduated in Chemistry in 1994 and in 1998 he achieved the Ph.D. in analytical chemistry from University of Palermo, Italy. He worked in a medical devices company as laboratory manager and he was technical director of an ethylene oxide sterilization plant. He was senior consultant in an international group, focused on computerized systems in the pharmaceutical environment. For four years he was responsible of the R&D department of Fedegari Autoclavi and now he is Principal Consultant of CTP, a European Consultancy Company. He is member of CEN Technical Committee 102 and of the Italian Standardization Body for the Heat Sterilization.

Giuseppe Ruggirello 博士,欧洲CTP咨询公司首席顾问 (意大利)。

Dr. Abdel Aziz Saleh got his PhD degree in Pharmaceutical Sciences from School of Pharmacy, University of Alexandria, in 1968. He was appointed as Professor of Pharmaceutics in 1981, and as Vice Dean of the school in 1986. In 1989 Dr Saleh joined WHO/EMR as the Regional Adviser for Pharmaceuticals. In 1995 he was appointed Director of the Division for Health Policy and Management. He has wide experience is supporting countries in developing health policies including drug policies, and health system development, with special emphasis on recent challenges in the 21st century.

Abdel Aziz Saleh 博士,WHO/EMR健康政策管理部主任(埃及)。

Mr. Hans Thomas has been with Bausch + Ströbel since 1972 and now holds the position of Sales and Marketing Director. He is responsible for the overseas market and in particular for Asia. After graduating in Mechanical Engineering he joined the still young company which has since developed into one of the major equipment manufacturers for pharmaceutical machinery. Over 34 years of experience in this market has provided Mr Thomas a deep insight into the fi eld of aseptic manufacturing.

Hans Thomas 先生,Bausch + Ströbel销售市场部经理 (德国)。

Dr. Minli Xie obtained M.S. degrees with honors, in Physical Organic Chemistry and in Pharmaceutical Chemistry. After graduating with her Ph.D. degree, she joined Dupont Merck Company as Research Scientist then promoted to Senior Research Scientist. In 2000, she was recruited by Bristol-Myers Squibb Company as Sr. Research Investigator. Her work has focused on discovery support, preformulation and formulation development to support early clinical studies. In 2003, Dr. Xie joined Genentech, Inc. to start a Small Molecule Pharmaceutics
Group.

Minli Xie 博士,Genentech公司小分子药物部经理(美国)。

Dr. David Zeng is a consultant for biopharmaceutical development. His expertise is in protein drug product development, API process, analytical methods, aggregate characterization, manufacture and regulatory fi lings. Dr. Zeng has 10 years of experiences in biopharmaceutical industry. His last industrial position was Associate Director in Pharmaceutical R&D of Pfizer Biologicals where he was responsible for the formulation development for all Pfi zer biologicals. Dr. Zeng received his PhD in Pharmaceutical Sciences from the University of Connecticut, and BS from the Northwestern University. He has published numerous of articles and patents in protein development and aggregate characterization.

David Zeng 博士,生物药剂开发顾问(美国)。