2007年8月31日
主席: 阿德尔•萨克尔教授,罗国安教授和张京华副局长- 片剂制造:辅料,性质和工艺: 9.00 - 9.45 a.m.: 萨克尔教授 (美国)
- 滚轮压制原理和处配方优化: 9.45 - 10.30 a.m.: Rezaei 博士(美国)
- 控制的湿法制粒过程 : 11.00 - 11.45 p.m..: Stahl 博士(德国)
- 草本辅助成分的研发和创新: 11.45 - 12.30. p.m.: Murray 博士 (美国)
- 药品的外包生产:药品发明人的展望 : 12.30 - 1.15 p.m.: Cammarn 博士 (美国)
- PAT 在产品开发中的应用: 2.15 - 3.00 p.m.: Hausman 博士 (美国)
- 片剂压制工具的选择: 3.00 - 3.45 p.m.: Natoli 先生 (美国)
- NIR在药剂生产和控制方面的应用: 4.15-5.00 p.m.: 王博士 (中国)
- 片剂质量控制的综述: 5.00-5.45 p.m.: 萨克尔教授 (美国)
- 讨论: 5.45 - 6.00 p.m.
- 小丸药制备工艺的综述 9.00 - 9.45 a.m.: Stahl 博士 (德国)
- 缓控释剂型释放的原理: 9.45.-10.30 a.m.: Lee 教授 (加拿大)
- 缓控释微丸包衣: 11.00 -11.45 a.m.: 李建新博士 (美国)
- 聚合物在长效制剂中的应用: 11.45 - 12.30: Siahboomi 博士 (英国)
- 生物相关的溶出试验法在开发长效缓释制剂中的应用: 12.30 - 1.15 p.m.: Klein 博士 (德国)
美国药典在质量控制/质量监督,生物利用度/生物等效性,态度和法规
- 药剂组分的控制 2:15 - 3:00 p.m. 活性成分和辅料: 美国药典的观点: Williams 博士(美国)
- 药剂组分的控制 3:00 - 3:45 p.m. 活性成分和辅料: 中国药典的观点: 杨教授(中国)
固体药物制剂的质量控制/质量监督:
4.15 - 5.00 p.m.
- 速释制剂:性能测试和方法学检验: Williams 博士 (美国)
- 缓控释制剂:性能测试和方法学检验: Williams 博士 (美国)
5:00 - 5:45 p.m.
- 速释制剂:Williams 博士(美国)
- 缓控释制剂: Williams 博士(美国)
- 讨论: 5.45 - 6.00 p.m.
Speakers

Dr. Stephen R. Cammarn is the Associate Director of Pharmaceutical Development with Procter & Gamble Pharmaceuticals in Cincinnati and Norwich. Dr. Cammarn holds a BS ChE and a PhD in Industrial Pharmacy. Dr. Cammarn has worldwide responsibility for P&GP’s drug product development work, including Pharmaceutics, Formulation, Process, Clinical Supplies, Package Development and Technical Support. In these capacities, Dr. Cammarn has been responsible for drug product aspects of numerous successful NDA’s and launches, and currently has the drug product responsibility for more than 20 projects in the portfolio. Dr. Cammarn holds several patents, and is the author of several publications.
Stephen R. Cammarn 博士,P&G药剂公司开发部副部长 (美国)。

Dr. Debbie Hausman is a Senior Engineer in the Process Development Department of Procter & Gamble Pharmaceuticals, Norwich, New York. She has 7 years of experience in drug product and process development. She holds a Ph.D. in Pharmaceutical Sciences from the University of Cincinnati, focusing on Industrial Pharmacy, and a B.S. in Chemical Engineering from the University of Michigan.
Debbie Hausman 博士,P&G 药剂公司工艺开发部高级工程师 (美国)。

Dr. John Hu is Vice President, International-China for the United States Pharmacopeia (USP) and General Manager, U.S. Pharmacopeia Research and Developme nt (Shanghai) Co., Ltd. In his management role at Shanghai, Dr. Hu provides public health and allied support to USP’s constituencies in mainland China, Taiwan, Hong Kong and Singapore. Dr. Hu was formerly a Director in Science, Technology and Outsourcing at Novartis and worked in various research and development capacities not only at that company but also at Bayer AG and Hoffman La-Roche. His expertise lies in project management, formulation research and analytical development.
John Hu 博士,美国USP中国部副部长,总经理 (中国)。
Dr. Sandra Klein is a pharmacist. She got her Ph.D. from the University of Frankfurt and
did her post-doc at Eastman Chemical Company, USA. She is presently working on the
improvement of biorelevant dissolution test methods for Modifi ed Release dosage forms,
the miniaturization of compendial dissolution test methods and on enhancing the solubility
of poorly soluble drugs.
Sandra Klein 博士,德国法兰克福大学的助理教授 (德国)。

Dr. Ping I. Lee is Professor and GlaxoSmithKline Chair in Pharmaceutics and Drug Delivery
at the University of Toronto. He holds a BS ChE and a PhD in Physical Chemistry. He has
held research and management positions with several major pharmaceutical companies. Prior
to returning to Toronto in 2004, he was Senior Director of Pharmaceutical R&D at Schering-Plough. His publications and patents are in areas of modifi ed release, hydrogels and drug
delivery systems. He co-founded the AAPS Modifi ed Release Focus Group and serves on the
Editorial Board of several international journals. He is a fellow of the AAAS.
Ping I. Lee 博士,多伦多大学教授,药剂和药物传递的GSK主席 (加拿大)。

Dr. Jian-Xin Li is Pharmaceutical Projects Manager in FMC Biopolymer, USA. He is responsible
for Excipient R&D projects and technical service activities in China. He has doctorate degree in
pharmaceutics, bachelor and master degrees in chemical engineering. Dr. Li has over 20 years
research and development experiences in polymer materials and formulations; is the 2005
chair and 2006 co-chair of the AAPS Modifi ed Release Focus Group. Dr. Li was the co-chair of
41st AAPS Arden Pharmaceutical Technologies Conference (2006) and a Steering Committee
Member of the Handbook of Pharmaceutical Excipients. His research interests include solid
dosage forms, drug delivery, controlled release and polymer excipients.
李建新博士,美国 FMC 公司制药项目经理(美国)。

Dr. Mary A. Murray is Senior Research Scientist in the Supplement Product Development
division of The Nutrilite Health Institute in Buena Park, California. She has 10 years industrial
experience in the research, design and development of nutritional supplements. Dr. Murray is a
global spokesperson representing the science behind the Nutrilite brand and holds numerous
patents in the formulation and development of nutraceutical products. She holds a PhD in
Pharmaceutical Sciences from the University of Cincinnati focusing on Industrial Pharmacy
and a BS in Biological Sciences also from the University of Cincinnati.
Mary A. Murray 博士,美国NUTRILITE健康研究院保健产品开发部高级科学家(美国)。

Mr. Dale Natoli is vice-president of Natoli Engineering and has over 25 years of experience training the tablet compression industry worldwide. Dale currently presents lectures for universities, pharmaceutical associations and tablet manufacturers on topics related to tablet designs, tool confi gurations and troubleshooting. He authored many articles for major pharmaceutical trade publications in the United States as well as in Europe. Dale is the driving force behind establishing new technologies and special tool confi gurations to the tablet compression industry; providing enhanced tablet quality as well as extended tooling and press longevity.
Dale Natoli 先生,Natoli Engineering公司的副董事长
(美国)。

Dr. Hamid Rezaei is currently a Scientist at the small molecules pharmaceutics division
at Genentech, Inc. Previously he worked for more than six years as a Formulation Senior
Scientist at AstraZeneca Pharmaceuticals. While at AstraZeneca, he worked in the product
design and process engineering (PAT) teams, and was an AAPS visiting scientist for three
years. He has extensive industrial experience with contributions to several INDs, sNDAs, and
NDAs. He holds a Ph.D. in Pharmaceutics/Industrial Pharmacy from University of Cincinnati,
and a M.S. in Pharmacology from the Ohio State University.
Hamid Rezaei 博士,Genentech公司小分子药物部的科学家(美国)。

Dr. Ali Rajabi-Siahboomi is Global Technical Director for Modifi ed Release Technologies at Colorcon, based in the USA. He obtained his B.Pharm. PhD in Pharmacy from University of Nottingham (UK). Ali has held various academic positions (7 years) in Nottingham and Liverpool JM Universities before joining Colorcon as Technical Director (Europe, Middle East and Africa). His main research interests are in the area of solid dosage form pharmaceutics and pharmaceutical technology with emphasis on modifi ed release drug delivery systems. He has published over 120 full papers, abstracts and patents.
Ali Rajabi-Siahboomi 博士,美国COLORCON公司改善制剂全球技术主任 (英国)

Dr. Harald Stahl owns a diploma in Physics and a PhD in Chemical Engineering. He worked for 3 years in the Pharmaceutical Development of Schering AG in Germany. At that time his main interest was the aseptic production of pellets. Since 1995 he served within GEA Powder Technology in various positions. Presently he owns the position of a Senior Pharmaceutical Technologist of NIRO Pharma Systems. He has published more than 20 papers on various aspects of solid dosage form production.
Harald Stahl 博士,NIRO公司高级制剂工程师 (德国)。

Dr. Roger L. Williams is Executive Vice President and Chief Executive Offi cer of the United States Pharmacopeia. Dr. Williams also serves as Chair of the Council of Experts, USP’s scientifi c standards-setting body, which: continuously revises the United States Pharmacopeia and National Formulary and, with USP’s recent acquisition, the Food Chemicals Codex; sets the Model Guidelines in support of the Medicare Modernization Act’s Part D Benefit; and creates other standards and information on behalf of USP’s constituencies. He has authored or co-authored over 200 reports in the areas of clinical pharmacology, patient safety, biopharmaceutics, pharmaceutical chemistry, and compendial science.
Roger L. Williams 博士,美国USP执行副主席和首席执行官 (美国)。

Dr. Qian Wang obtained her Ph.D. in Physical Chemistry from Boston University in 1990, after which she joined Boston Advanced Technologies as a research scientist. Since 1995 she has worked at Bruker Optics on applications of NIR. She currently holds the position of Vice President of NIR and Process.
Qian Wang 博士,Bruker Optics 公司NIR和过程部副部长 (中国)。

Prof. Zhong-Yuan Yang graduated from China Pharmaceutical University in 1964. He is a Senior Chemist, and was the former Director of Wuhan and Guangzhou Municipal Institute for Drug Control. He was invited by the Chinese Pharmacopoeia Commission as a member of the current Executive Committee. He is a member of Drug Evaluation Board of the State Food and Drug Administration, an advisor to the Guangdong Provincial FDA, a member of the WHO Panel on International Pharmacopoeia and Pharmaceutical Preparations, a member of United States Pharmacopoeia Expert Committee of International Health (2005-2010), a member of editorial board of Acta Pharmaceutica Sinica and some other scientifi c journals.
杨仲元教授 中国药典委员会执行委员会委员(中国)。

Tabletting, Pat and Controlled Release Technologies (english version)