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Nikoletta Fotaki, Pharmacist, MSc, PhD
Associate Professor, University of Bath, UK

Dr Nikoletta Fotaki is a UK registered Greek Pharmacist, with an MSc in Toxicology and a PhD in Biopharmaceutics-Pharmacokinetics. She participated in several research projects in the School of Pharmacy of the National and Kapodistrian University of Athens and in Hoffman La Roche (Pharmaceutical and Analytical R&D, New Jersey, USA) before her academic appointment at the University of Bath. She has also worked in the National Organisation for Medicines in Greece. Her expertise and research are focused on PBPK modeling, drug absorption, development of in vitro screening tools and associated software for predicting absorption and in vivo performance in normal populations and in special populations (i.e. paediatrics, disease states), biorelevant dissolution methods, dissolution imaging, development of in vitro-in vivo correlations and relations, formulation development, animal models for the prediction of absorption, methods for reduction/ refinement/ replacement of animal experimentation, biowaivers, dissolution testing, design of BA/BE studies, in silico models, pharmacokinetics. She is a reviewer and scientific advisor of several scientific journals, an Associate Editor for AAPS Open and member of the editorial board of Dissolution Technologies and DiePharmazie. She is an Associate Fellow of the Higher Education Academy and has been involved in the evaluation of several research proposals. She is also an Adjunct Assistant Professor in the University of Waterloo (Canada). She is a member of several scientific societies and active member of various steering committees and the chair of the IVRDT Focus Group of AAPS. She has organised and moderated sessions in American Association of Pharmaceutical Scientists annual meetings, in American College of Clinical Pharmacology and has been an invited speaker at several conferences and seminars.

 

Nikoletta Fotaki 博士是英国巴斯大学副教授、在英国注册的希腊药剂师、毒理学硕士、生物药剂学-药物代谢动力学博士。在巴斯大学任教之前,她参与了位于雅典的国立卡布迪斯特林大学和霍夫曼罗氏制药公司(新泽西,美国)的多项制剂研发和分析研究项目。她曾任职于希腊国家药品监管机构。她研究的重点是生理药代动力学模型(PBPK)、药物吸收、体外筛选方法及用于预测普通群体和特殊群体(即儿童、病情)吸收状况和体内行为的相关软件的开发、生理相关的溶出度方法、溶出成像技术、体内外相关性(IVIVC和IVIVR)、制剂处方研究、预测药物吸收的动物模型建立、减少/改进/替代动物实验的方法、豁免体内研究、溶出度技术、BA/BE研究设计、计算机模型、药代动力学。她是多个学术期刊的审稿人及科学顾问,AAPS Open期刊的副主编, Dissolution Techno-logies 和 DiePharmazie的编委。她是高等教育学院的副研究员,参与了许多研究申请的评估。她也在滑铁卢大学(加拿大)客座助理教授。她也是一些科学团体和指导委员会的成员,还担任AAPS IVRDT聚焦组的现任主席。她曾在AAPS年会及美国临床药理学会年会上组织并主持会议,并担任多个重要会议和研讨会的演讲嘉宾。

Vivian A. Gray,
Owner, V. A. Gray Consulting, Inc.,
Hockessin, DE, USA

Vivian Gray has spent the last 39 years involved in all aspects of dissolution testing. She worked for USP for 23 years and in 1997 joined the DuPont–Merck Pharmaceuticals Company as Head of the Analytical R & D Dissolution Group. Vivian now serves on the USP Pharmaceutical Dosage Form Expert Committee and is chair of the USP Expert Panel on Gelatin Capsule issues and the USP Expert Subcommittee on Performance Verification Standards. She has authored over 50 articles, including 6 book chapters.  She has been an invited speaker for conferences in over  55 occasions (Fourteen of these were International invitations), lecturing especially in the areas of calibration, dissolution equipment, sources of error in dissolution testing, method development and validation, new technology, and regulatory topics.

In 2002, she began a consulting business in dissolution testing and related areas.  The company name is V. A. Gray Consulting, Inc., www.vagrayconsulting.net. Vivian is also Managing Director of the publication, Dissolution Technologies, www.dissolutiontech.com, a quarterly, international peer-reviewed journal on dissolution and related topics.  She co-authored a book titled “Handbook of Dissolution Testing”, Third Edition.

Vivian is a member and one of the co-founders of the American Association of Pharmaceutical Scientists (AAPS) In Vitro Release and Dissolution Testing Focus Group. She is also a member of American Association of Pharmaceutical Scientists (AAPS).

 

Vivian Gray女士是V. A. Gray Consulting, Inc., 拥有人,连续39年从事与溶出相关的研究。曾在USP工作了23年,1997年加入DuPont-Merck制药公司,被任命为分析研发溶出小组的负责人。她目前是USP药物制剂委员会专家,并担任明胶胶囊USP专家小组和药品性能确认标准分委会主席。她已发表了50多篇文章,其中包括一本书中的六个章节。应邀出席50多次会议(其中14次都是国际性的邀请)并进行演讲,演讲的内容主要是仪器校准、溶出设备、溶出试验中常见问题、方法的开发和验证、新技术、监管问题等。 2002年,她建立了一个以溶出试验和相关领域为主的咨询公司。公司命名为V.A.Gray咨询有限公司,Vivian也是Dissolution Technologies,www.dissolutiontech.com期刊和网站的管理者,Dissolution Technologies为季刊。她也是“溶出度试验技术”第三版的共同作者。 她既是美国药学会(AAPS)体外释放和溶出技术聚焦小组(IVRDT)的成员,又是创始人之一。

Jian-Hwa Han

Jian-Hwa Han is a technical leader of the Dissolution Group in Global NCE Analytical R&D at AbbVie (formerly Abbott Laboratories). Jian-Hwa earned his Ph.D. degree in Analytical/Colloid Chemistry at Clarkson University, N.Y. in 1990. Jian-Hwa joined Abbott in 1990, and since then he has worked in Formulation/Drug Delivery, Bio-analytical group for protein analysis and Process Chemistry. In 2001, he moved to the Dissolution Group. His focus is in vitro drug release research and method improvement for dissolution testing. Over these years, he has worked on many different projects with different formulation designs, and became an expert for in vitro drug release characterization. Now, he is very enthusiastic about establishing new practices for developing dissolution methods to support clinically relevant specifications. He is an expert in gelatin-crosslinking behavior and Tier-2 test method development, and serves in the USP Expert Panel on this subject. He has contributed to several IND, NDA, MAA and IMPD filings. Specialties: Dissolution Testing Method Development & Validation, Clinical-relevant In-vitro Drug Release Method Development

 

Jian-Hwa Han艾伯维(原雅培公司)公司全球新化合物(NCE)分析研发溶出部门的技术负责人。
Jian-Hwa Han在纽约克拉克森大学获得分析/胶体化学方向的博士学位。1990年,Jian-Hwa Han加入雅培公司,主要致力于制剂/药物递送方面的工作,在生物分析部门进行蛋白质分析和工艺化学的研究。2001年,转入溶出研究部门。他的工作重点是体外释放研究及溶出实验方法的改进。他参与了多个处方设计的研究项目,已经成为体外释放研究方面的专家。现在,他致力于建立支持临床质量标准的溶出新方法的建立。他是明胶交联行为和二阶段(Tier-2)测试法研究方面的专家,是USP专家小组成员。他参与多个IND,NDA,MAA和IMPD的申报资料起草。

专业:溶出试验方法的建立和验证,与临床相关的体外释放方法的研究。

 

 

Dr. Johannes Krmer
CEO, PHAST GmbH, Germany

Dr. Krmer is the founder and managing director of the “PHAST group” with sites in Germany, France, and Switzerland. Since 1987, he is working in the field of dosage form performance testing. He obtained his states diploma in pharmacy from Frankfurt University. After specializing in pharmaceutical analysis, he obtained his Ph.D. in pharmaceutical technology and biopharmacy from Heidelberg University. Dr. Krmer is an elected member of the USP Dosage Forms Expert Committee. With the International Pharmaceutical Federation (FIP) he is member of the Focus Group on Dissolution/In Vitro Release Performance Testing. He is a member of the American Association of Pharmaceutical Scientists, the Biopharmaceutics Group within APV (International Association for Pharmaceutical Technology), and the Deutsche Pharmazeutische Gesellschaft (DPhG). His scientific interest is focused on IVIVC-based (in vitro in vivo correlations) in vitro performance testing method-development for pharmaceutical dosage forms, with special regard to stability problems. He is the author of several publications and several book chapters as well as coeditor of a book on dissolution testing.

 

Johannes Krmer博士是“PHAST集团”的创始人兼首席执行官。1987年起,他一直从事制剂性能试验的研究。
他从法兰克福大学获得药学专业的国家文凭并专门从事药物分析工作,后获得海德堡大学制药技术和生物药学方向的博士学位。
Krmer博士是USP药剂专业委员、国际药学联合会溶出/体外释放性能试验聚焦小组成员。他还是AAPS、国际制药技术协会(APV)生物药剂学小组、德国制药公司协会(DPhG)的成员。他的科研重心是基于体内外相关性的药物制剂体外试验方法特别是与稳定性相关的研究,参编多部与溶出试验相关的专著。

Dr. Xujin Lu
Senior Principal Scientist,
Analytical and Bioanalytical Development

Bristol-Myers Squibb Company

He received his Ph.D. in Analytical Chemistry from the University of Georgia at Athens.  He also received a M.S. in Analytical Chemistry from Chinese Academy of Sciences at Dalian Institute of Chemical Physics. Prior to joining BMS, he completed a postdoctoral fellowship in the University of Illinois at Champaign-Urbana. With more than 24 years of experience in the pharmaceutical industry focused on research and development, Dr. Lu has involved in a broad range of functions and development of various pharmaceutical products including solid oral dosage, parenteral liquid and lyophile, immediate release and controlled release, small molecules, millamolecules and proteins, and made key contributions to a number of IND/NDA filings and products launch. He also developed technical expertise and initiated implementation of new technologies for pharmaceutical analyses.  He received “Outstanding Achievement in Analytical Chemistry Award” from Bristol-Myers Squibb Company in 2013 when the award was established for the first time.  His current interests are in drug release and dissolution and use of in-vitro biorelevant testing for formulation development and pre-formulation studies.  He has been an invited speaker at conferences, workshops and seminars, and organized and chaired sessions in a number of conferences including American Association of Pharmaceutical Scientists Annual Meetings and National Biotechnology Conference.  He was the Chair of the In Vitro Release and Dissolution Testing (IVRDT) Focus Group of AAPS from 2013 - 2015.  He currently serves as a member of the Editorial Advisory Board of Dissolution Technologies journal.

 

吕旭进博士是百时美施贵宝公司(BMS)分析和生物分析研发部门的资深首席科学家。他在美国乔治亚大学获得分析化学博士学位,早年在中国科学院大连化学物理研究所获得分析化学硕士学位。加入BMS之前,他在厄巴纳香槟的伊利诺伊大学从事博士后研究。就职于BMS24年来,他一直专注于制药研发,参与了多种药制剂的研制与分析检测方法的建立,验证,和转移,并为多个IND/NDA申请和药品上市做出了贡献。他还致力于专业实验技术的开发,并启动实施了多项新技术在药物分析中应用。2013年获得百时美施贵宝公司首次创立的“分析化学杰出成就奖”。他现在的研究领域包括药物释放、溶出以及生物相关体外试验在处方研究和处方前研发中的应用。多次担任专业会议和研讨会的演讲嘉宾, 在多个重要会议包括AAPS年度会议和国家生物技术大会上组织和主持会议。从2013-2015年,他是AAPS体外释放和溶出技术 (IVRDT) 聚焦组的主席。目前还担任Dissolution Technologies 的编委。

 


Erika Stippler, Ph.D.

Erika Stippler, Ph.D. is the Director of the Dosage Form Performance Laboratory at the U.S. Pharmacopeia in Rockville, MD. She has more than 20 years of experience in the pharmaceutical industry having been at various contract research organizations in Germany and Switzerland and now currently working at USP.
Erika began her career as an analyst in Zentrallaboratorium Deutscher Apotheker, Eschborn. In 1996 she proceeded to attend the W. J. Goethe University Frankfurt Institute of Pharmaceutical Technology as an external Ph.D. student. With the thesis title “Biorelevant Dissolution Test Methods to Asses Bioequivalence of Drug Products” she received her Ph.D. under the guidance of Prof. Dr. Jennifer B. Dressman. Between 1998 and 2002, she was head of Biopharmacy/Stability Testing of Laboratory and Quality Services in Eschborn, Germany. Dr. Stippler has also been Technical Director of PHAST laboratories and Project Manager at Solvias, Switzerland before coming to USP.
Her scientific interest is focused on IVIVC-based dissolution method development for various dosage forms and on the characterization and standardization of dissolution apparatus and dissolution methods for performance evaluation of pharmaceutical products.
Currently she is involved in PQRI activities, where she chairs the Biopharmaceutics Technical Committee.
She is also a member of American Association of Pharmaceutical Scientists (AAPS).

 

Erika Stippler博士,是美国药典委员会(USP)制剂实验室主任。她已在制药行业工作了2 0多年,也曾在德国和瑞士的多个合同研究组织工作。Erika 的职业生涯开始于Zentrallaboratorium Deutscher Apotheker制药公司的分析员。1996年,她作为外部博士生进入W.J.法兰克福歌德大学药物技术研究所继续深造,师从Jennifer B.
Dressman教授,她的博士论文题目为“生物相关的溶出试验方法评价药品的生物等效性”。1998-2002年,她是德国埃施博恩实验室生物药学/稳定性测试和质量检测的负责人。加入USP之前,Stippler博士曾是PHAST实验室的技术总监和瑞士Solvias 公司的项目经理。
她的研究领域主要是基于体内外相关性的药物制剂的溶出方法建立、溶出仪和药物制剂评价方法的研究和标准化。
目前,她参与PQRI活动并担任生物药剂学委员会主席,Stippler 博士也是美国药学会 (AAPS)成员。

Dr. Jiasheng Tu

Dr. Jiasheng Tu obtained his B.S. degree in Pharmacy from Peking University Health Science Center (Former Beijing Medical University) in 1986, and Ph.D. degree in Pharmaceutics from China Pharmaceutical University in 1992. He also took a 2-year postdoc program in University of Pacific, Stockton. Now, he is a professor and Ph.D. supervisor in Pharmaceutical Sciences, China Pharmaceutical University. He is a both CHP and USP committee member, and was appointed as the deputy chair of CHP excipient and package material committee, chair of USP MCEA, and consultant of CDE.
The researching interests for Dr. Tu include modified-release systems, targeting delivery of antitumor drugs and R&D of pharmaceutical excipients. In the past five years, Dr. Tu was funded by Ministry of Technology (National Science and Technology Major Project), National Natural Science Foundation of China, China Pharmacopeia, and so on. Dr. Tu has authored over 100 peer-reviewed publications and two invited book chapters.


涂家生,中国药科大学药剂学教授、博士生导师,国家药典委员会委员(药用辅料和包材委员会副主任)、国家药品审评专家、美国药典会委员、江南大学兼职教授、美国University Of the Pacific客座教授; AAPS(美国药学科学联合会)会员;中国药学会高级会员;中国医药生物技术协会常务委员;江苏省药师协会指导委员;《药物生物技术》、Asian Journal of Pharmaceutical Sciences编委。
从事药物传递技术的研究和开发工作多年,研究方向是新制剂和新技术。近年来,主持和参加NIH的靶向多肽的设计和合成、科技部科技支撑计划“注射用药用辅料的安全性和质量”、自然科学基金项目“肿瘤靶向的SiRNA传递载体的设计和评价”、国家115药物制剂创新平台“药物传递技术平台建设”、国家125重大专项“mPEG-PDLLA的应用关键技术”和国家药典委员会药用辅料标准提高计划等纵向项目。

Wang Wei

Wang Wei, male, chief pharmacist, director of chemical laboratory in Tianjin Institute for Drug Control, Tianjin drug and cosmetics evaluation expert, Tianjin health food and cosmetics advisory committee expert, Tianjin medical equipment and technical expert.
He graduated from East China Institute of Chemical Technology in 1988, major in chemical pharmaceutics; being a visiting research fellow in School of Pharmacy in Nihon University in Japan from October 2003 to June 2004.
He mainly engaged in drafting, revision and review of the national drug standards such as for Chinese Pharmacopoeia, quality standard review of the import and domestic drugs registration, inspection of import drugs, the national drug evaluation testing, the local drug sampling, the commissioned testing, etc.
He completed over one hundred monographs of quality drafting and review for Chinese Pharmacopoeia, 2000 to 2015 version and other import and domestic drugs registration. Scientific research programs he charged in were rewarded the third prize of Tianjin Science and Technology Progress, two items of the second prized and one item of the third prize of Tianjin Municipal Food and Drug Administration. He published more than 20 papers in the national journals.


王卫,男,主任药师,天津市药品检验所化学室主任。现任天津市药品化妆品审评专家、天津市保健食品化妆品专家咨询委员会专家、天津市医疗器械技术专家等职务。
1988年毕业于华东化工学院化学制药专业。于2003年10月-2004年6月在日本大学药学部访问学习。
主要从事《中国药典》等国家药品标准的起草、修订和复核工作,进口及国内药品注册质量标准复核工作,进口药品检验、国家药品评价性抽验、地方抽验和委托检验等工作。
完成了《中国药典》2000年版至2015年版、进口及国内药品注册等上百个品种的质量标准起草和复核工作。所负责的科研课题获得天津市科技进步三等奖1项,天津市食品药品监督管理局科技进步二等奖2项、三等奖1项。在国家级杂志上发表第一作者论文20余篇。
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2016年6月21-22日

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2016年5月31日

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2016年6月20日