各有关单位：
为了解和跟踪国际药品标准制定最新进展，强化标准执行对保障药品质量的重要作用，推进各国药典机构在标准制定和标准认证方面的交流与合作，以“标准先行”助力我国制药走向国际，提升产业国际竞争力，国家药典委员会定于2019年6月20-21日在江苏省徐州市举办“2019国际药品标准制定和标准认证专题研讨会”。
会议将邀请世界卫生组织（WHO）、美国FDA驻华机构、欧洲药品质量管理局（EDQM）、英国药典委员会（BP）、美国药典委员会（USP）等机构负责人，国家药品监督管理局有关领导，食品药品审核查验中心、上海市药品审评查验中心、深圳市药品检验研究院以及有关企业的专家和代表围绕会议主题进行报告，全面介绍各国药典标准制定的最新动态，解读各国药品标准认证的审评流程和技术要求，讲解WHO实验室预认证的工作流程，交流药品现场检查中标准执行的问题，分享制药企业在药品、原料药、药用辅料申请国际药典机构认证的经验。
本次会议由国家药典委员会主办，中国健康传媒集团承办。
现将会议有关事宜通知如下：
一、时间和地点
（一）时间：2019年6月20至21日召开，6月19日报到，会期一天半。
（二）地点：江苏省徐州市博顿温德姆酒店
地址：徐州市鼓楼区经济开发区龙湖西路16号
电话：0516-81918888
二、参会人员
主要包括药品监管部门的管理人员以及药品、原料药、药用辅料研发、生产、检验相关机构、科研院所、生产企业的管理人员和专业技术人员。
三、会议内容
（一）国际性、区域性以及各国药典标准制定最新进展。
（二）各国药典机构标准认证程序、申报资料要求和审评技术要求。
（三）世界卫生组织实验室认证技术要求和经验分享。
四、嘉宾介绍（顺序按日程排序）
张伟
张伟先生自2013年1月起担任中国国家药典委员会秘书长。此前，于2006年2月至2012年担任原国家食品药品监督管理局药品注册司司长一职。另外，还曾担任北京市药品监督管理局副局长、北京市药品检验所所长、原北京卫生局药政处副处长等职。
Zhang Wei has been the Secretary General of Chinese Pharmacopoeia Commission(ChPC) since January 2013. Prior to joining ChPC, he had been the director-general of department of Drug Registration of the State Food and Drug Administration in china from February 2006 to December 2012, the deputy director of Beijing Drug Administration and Director of Beijing Institute of Drug Control, deputy director of Division of Drug Administration of Beijing Bureau of Public Health.
Sabine Kopp
Sabine Kopp是世界卫生组织(WHO)药品质量保证小组的负责人。在世卫组织的多个职位中，她曾担任INN项目秘书、药品质量保证和安全代理小组协调员、质量保证和打假项目项目经理，国际医疗产品防伪工作组(IMPACT)代理秘书，并积极参与世卫组织成员国关于劣质/假冒/假标签/伪造/假冒医疗产品的协调机制。
Sabine博士是WHO制剂规范专家委员会负责人，负责协调活动的相关国际指南的开发和维护，标准和规范药品质量保证和相关国际药典，从事规范药品质量保证工作，规范从开发和制造到药品的分销和供应。她负责监督世卫组织质量控制实验室外部质量保证评估计划，Sabine博士担任世界药典国际会议秘书，并积极参与世卫组织旨在促进全球药物质量保证的协同和融合的各种活动。
Sabine Kopp is the Lead of the World Health Organization’s (WHO) Medicines Quality Assurance group. Among the various positions she held in WHO she was Secretary for the International Nonproprietary Names (INN) Programme, Acting Team Coordinator for Quality Assurance and Safety of Medicines, Programme Manager for the Quality Assurance and the Anticounterfeiting programmes, Acting Secretary of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) and was also actively involved in the WHO Member State mechanism on Substandard/spurious/falsely-labelled/falsified/counterfeit medical products.
Sabine Kopp is Secretary of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and is responsible for the coordination of WHO's activities related to the development and maintenance of international guidelines, GXPs, standards and norms related to Medicines Quality Assurance and the International Pharmacopoeia, i.e. the normative work related to Medicines Quality Assurance within WHO, spanning from development and manufacturing to the distribution and supply of the medicines. She is overseeing WHO’s External Quality Assurance Assessment Scheme for quality control laboratories, serving as Secretary the international meetings of world pharmacopoeias and involved in WHO activities aimed at enabling synergies and convergence in medicines quality assurance globally.
James Pound
James Pound 英国药典委员会秘书长（主任），他于2008年加入英国药品与保健品管理局。曾在英国药典(BP)及实验室担任多个职位，并于2017年晋升为英国药典会秘书长（主任）。
作为英国药典的负责人，他负责药典和该机构的监管以及实验室检测活动。James Pound拥有化学荣誉学位，此前曾在全球制药企业担任分析化学方面的多个职位。
James Pound joined the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) in 2008. He has worked in a variety of roles within the British Pharmacopoeia (BP) & Laboratory Services Group and in 2017 was promoted to the role of Group Manager British Pharmacopoeia & Laboratory Services, and Secretary & Scientific Director of the BP Commission.
He is a senior leader within the Agency and has responsibility for both the pharmacopoeia and the Agency’s regulatory laboratory testing activities. He holds an honours degree in Chemistry and has previously worked in a variety of roles focused on analytical chemistry for global pharmaceutical manufacturers.
董江萍
董江萍女士，主任药师，国家药监局食品药品审核查验中心副主任。
2000年10月-2011年11月，就职于原国家药品监督管理局药品审评中心，历任药学专业审评员、审评管理与协调部副部长、信息部部长；2011年12月至2016年3月，先后就职于原国家食品药品监督管理局、原国家食品药品监督管理总局。2016年3月至今任国家药品监督管理局食品药品审核查验中心副主任。
Ms. Jiangping Dong, Deputy General Director for CFDI(Center for Food and Drug inspection of NMPA ).
From October 2000 to December 2011, worked in the Drug Evaluation Center as pharmaceutical professional assessor, deputy director of the assessment management and coordination department, director of the information department. From December 2011 to March 2016, worked in the SFDA and CFDA. Since March 2016, she has been the deputy director of the food and drug inspection center of NMPA.
Gabriel Giancaspro
Giancaspro博士是美国药典（USP）膳食补充剂和草药科学部副总裁。他的部门向负责制定美国药典膳食补充剂、草药和食品成分标准的专家委员会提供支持。
在此之前，他曾担任USP文献标准部膳食补充剂主管，负责植物和非植物膳食补充剂专著和通则的开发，安全性评估，性能标准以及USP膳食补充剂纲要的出版。
在加入USP之前，Giancaspro博士在布宜诺斯艾利斯大学药学院负责药物化学、药物分析和药物稳定性的教学和研究。他还拥有丰富的行业经验，曾任里格辛、施瓦贝-阿根廷和坎佩尔马蒂安公司技术总监，负责监管事务、分析研究和开发，以及对肠外注射物、草药和肿瘤药物的质量控制。
Giancaspro博士拥有药剂师学位和阿根廷布宜诺斯艾利斯大学的药学（药物化学）博士学位。
Dr. Giancaspro is the Vice President, Science—Dietary Supplements and Herbal Medicines, for USP. His department provides staff support to Expert Committees responsible for setting USP’s standards for dietary supplements, herbal medicines, and food ingredients.
Previously, he was the Director for Dietary Supplements in the Documentary Standards Division at USP responsible for the development of monographs and general chapters for botanical and non-botanical dietary supplements, safety evaluations, performance standards, and the publication of the USP Dietary Supplements Compendium.
Before joining USP, Dr. Giancaspro's teaching and research experience included medicinal chemistry, drug analysis, and drug stability at the Pharmacy School at the University of Buenos Aires. He also has extensive industrial experience as the former Technical Director of Rigecin, Schwabe-Argentina and Kampel-Martian, in charge of Regulatory Affairs, Analytical Research and Development, and Quality Control of parenterals, herbal medicines, and oncological medicines.
Dr. Giancaspro holds a Pharmacist degree and a Ph.D. in pharmaceutical sciences (medicinal chemistry) from the University of Buenos Aires, Argentina.
Pascale POUKENS-RENWART
Pascale POUKENS-RENWART 博士在比利时列日大学学习药剂学并获得了博士学位，并同时在1988-1994年期间担任研究助理。她担任研究助理。
从1997年到2000年，她担任比利时卫生局的化学药品评估员，负责质量部分的评估销售授权申请。
2000年，她加入了欧洲药品质量管理局(EDQM)的认证部门，担任该部门的科学官员，负责新申请的评审工作。从2010年至2017年，担任修订部门主任。自2017年至今，担任质量保证和认证部门主任。
Dr Pascale POUKENS-RENWART studied Pharmacy at the University of Liège, Belgium. She obtained a PhD degree in Pharmacogosy from the same university in 1994 where she worked as research assistant (1988-1994).
From 1997 to 2000 she was chemical-pharmaceutical assessor at the Belgian Health Authorities and was in charge of the evaluation of the quality part of the dossiers for marketing authorisation applications.
Then in 2000, she joined the EDQM (European Directorate for the Quality of Medicines) in the Certification Department, as Scientific Officer in charge of the assessment of new applications.
From 2010 to 2017 she was Head of the Revisions Section in the same Department. Since 2017 till now she is the Head of the Quality Assurance and Scientific Support Section from the Certification Department.
洪小栩
洪小栩，任国家药典委员会业务综合处工作副处长，负责组织2020年版和2015年版《中国药典》四部的编制工作，包括凡例、检验方法通则、指导原则、药用辅料和药包材相关标准。先后参与了《中国生物制品规程》2000年版、《中国药典》三部2005年版、2010年版、2015年版的制修订工作。
Dr. Hong works for the comprehansive department of Chinese Pharmacopoeia Commission and is responsible for developing the Chinese Pharmacopoeia volume IV 2015 and 2020 edition, including the general requirements, general chapter (testing methods), guidelines, pharmaceutical excipients as well as the drug package. worked for the biologics standards department of ChPC and participated the development of Ch.P Vol .III 2000, 2005, 2010 and 2015 edition.
Stephen W. Andruski
Steve拥有威斯康辛大学密尔沃基分校化学学士学位。毕业后，他先就职于Aldrich化学公司，负责新增目录化合物的小规模生产和工艺开发。随后Steve在亚利桑那大学获得了有机化学博士学位。在堪萨斯大学完成博士后工作后，Steve加入了富美实公司（FMC）的工艺研发组，从事新型农药的工艺研发，支持法规注册，并领导杂质合成实验室。在FMC工作了近十年后，Steve加入了奥尔巴尼分子研究公司（AMRI）的化学开发小组，为GMP合成临床试验原料药开展小规模定制合成、合成路线探索和规模化生产。Steve随后进入分析部门，负责方法开发、方法验证和GMP生产，在AMRI大型GMP生产工厂领导一个由6名分析师组成的团队。
在AMRI工作12年后，结合了他所具备的合成、工艺和分析化学背景，以及他对GMP法规和质量原则的熟悉程度，Steve加入USP成为认证项目高级经理。
Steve received his BS in Chemistry from the University of Wisconsin – Milwaukee. After graduating, he worked at Aldrich Chemical Company doing small-scale production and process development for new catalog compounds. Steve subsequently obtained his PhD from the University of Arizona in Organic Chemistry. Following post-doctoral work at the University of Kansas, Steve joined the Process Research group at FMC Corporation performing process R&D on novel pesticides, supporting regulatory registrations and leading lab work on the synthesis of impurities. After nearly ten years at FMC, Steve left to join the rapidly-growing contract research organization AMRI, initially in the Chemical Development group working on small-scale custom synthesis, route-scouting and scale-up work for the GMP synthesis of clinical trial APIs. Steve then moved into the Analytical Department performing method development, method validation and support of GMP production, eventually leading a group of six analysts at AMRI’s large-scale GMP manufacturing facility.
After almost twelve years with AMRI, Steve left to join the Verification Program staff at the US Pharmacopeia where he is currently a Senior Manager. This position combines Steve’s synthetic, process and analytical chemistry background, and his familiarity with GMP regulations and quality principles.
涂家生
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、执行委员（药用辅料和包材委员会主任）、国家药品审评专家、美国药典会辅料正文专业委员会委员、中国药学会制剂委员会委员；《药物生物技术》、Asian Journal of Pharmaceutical Sciences、中国新药杂志、中国药品标准编委。
先后在北京医科大学（1981-1986，获学士学位）、中国药科大学（1986-1992，获博士学位）学习。一直在中国药科大学从事药剂学教学、科研工作。近年来，主持和参加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、国家药品审评中心技术支撑计划、国家新药创制重大专项“口服制剂质量和疗效一致性”等纵向项目。并主持多项新药、新剂型的研发。
Jiasheng Tu is the professor of pharmaceutics of China Pharmaceutical University, a supervisor of doctorate students. Dr. Tu has also served as the chair of CHP pharmaceutical excipient committee, an expert committee member of CHP, an expert committee member of pharmaceutical excipient of USP.
Dr. Tu graduated from Beijing Medical University. He was awarded Ph.D. of pharmaceutics in China Pharmaceutical University at 1992 and did postdoctoral researches in University of the Pacific, CA, during 2001-2003.
李江宁
李江宁，汉族，*共中***党**员，执业药师，副主任药师。中国药科大学微生物制药专业毕业，工学学士。2007年获外交学院法学硕士学位，国家药品GSP认证检查员，国家药品GMP高级认证检查员，曾任原北京市药品监督管理局海淀分局副局长、原北京市药品监督管理局药品医疗器械流通处处长，现任国家药品监督管理局药品注册管理司综合处处长。
李江宁长期从事药品和医疗器械监管工作，自2017年开始全面参与药品审评审批制度改革工作，对药品监管工作和药品审评审批制度改革有着较为系统的了解。
Mr. Jiangning Li, Pharmacist, graduated from China Pharmaceutical University majoring in microorganism pharmacy. In 2007, he received his Master's degree in law from China Foreign Affairs University.
He is the national drug GSP certification inspectors, senior national drug GMP certification inspectors. Former Deputy Director of the Drug Administration of Beijing Haidian District and Director of medical equipment of Beijing Drug Administration. His current position is Director of General Office of Drug and Cosmetics Registration Division of NMPA.
Howard Sklamberg
Howard Sklamberg先生是Akin Gump Strauss Hauer & Feld LLP律所的合伙人。2014年4月至2017年4月，他担任美国食品药品管理局副局长，主要负责全球监管业务和政策，负责监管事务办公室和国际项目办公室。他领导或共同领导了许多质量和安全方面的工作(包括药品检验现代化等)、执法政策、谈判和实施，以及进口实施等。并领导了FDA的全球和多边合作及其海外办事处，包括中国办事处。Howard Sklamberg先生还曾担任药物评价和研究中心主任以及监管事务部副局长。
Howard Sklamberg is a partner at Akin Gump Strauss Hauer & Feld LLP. From 2014-April 2017, Howard served as USFDA’s Deputy Commissioner for Global Regulatory Operations and Policy, where he oversaw the Office of Regulatory Affairs and the Office of International Programs. He led or co-led many quality and safety efforts (including drug inspection modernization and program alignment), enforcement policy, the negotiation and implementation of user fees, and import enforcement. Howard directed FDA’s global and multilateral initiatives and its overseas offices, including its China Office. Howard also served as Director of the Center for Drug Evaluation and Research’s Office of Compliance and Deputy Associate Commissioner for Regulatory Affairs.
陈桂良
陈桂良，上海药品审评核查中心主任，主任药师，博士生导师，国家药典委员会委员；多本杂志编委，参编专著9本，国内外杂志上发表论文160多篇。参与负责上海市科学技术委员会科技项目与国家药典委员会专项课题多项。长期从事药品质量标准研究、吸入制剂体内外评价方法的建立以及药品审评与核查工作等。
Dr. Chen Guiliang is the director of Shanghai Center for Drug Evaluation and Inspection. He is a member of Chinese Pharmacopoeia Commission. He is also an advanced member of the Committee of Pharmaceutical Analysis in China Pharmaceutical Association. Dr. Chen has taken part in edit of 9 separate books. Till now he has had more than 160 research papers published in domestic and foreign journals. He is an editorial member of several Chinese Journals. He has been in charge of several scientific projects of Shanghai Science & Technology Committee and Chinese Pharmacopoeia Commission. Dr. Chen has long been specializing in the research of pharmaceutical quality standard, the establishment of in vitro/in vivo evaluation of inhalers, drug evaluation and inspection, etc.
王晓炜
王晓炜，天然药物化学博士，主任药师，深圳市药品检验研究院副院长、质量负责人。从事药品、医疗器械、保健食品、化妆品相关检验工作23年，具备丰富的实验室管理、检验检测及质量标准研究的经验；是世界卫生组织（WHO）药品质量控制实验室同行评审评审员，国家实验室认可及检验检测机构资质认定技术评审员，药品生产企业GMP检查员；参加WHO对赞比亚国家药检实验室及中国大连市药品检验所的同行评审，参加第4、5、6届WHO药品质量控制实验室预认证区域研讨会并受邀做大会发言交流。
Wang Xiaowei, Ph.D., Chief Pharmacist, Deputy Director of Shenzhen Institute for Drug Control (SZIDC), Quality Manager. She has been engaged in drugs, medical devices, health food, cosmetics related testing work for 23 years, with a wealth of laboratory management, testing technique and method research experience; She is WHO RSS Medicines Quality Control Laboratories(QCL) Peer Auditor, CNAS and CMA laboratory inspector, GMP inspector; She was invited to join in WHO prequalification team peer audit mission of Zambia Medicines Regulatory Authority(ZAMRA) QCL, Lusaka, Zambia in 2016, and Dalian Institute for Drug Control(DIDC), Dalian, China in 2019, and was invited to attend and address the 4th, the 5th and the 6th WHO Interregional Seminar for QCL involved in the WHO Prequalification.
丁恩峰
丁恩峰，担任上海复星医药产业发展有限公司副总经理，同时担任MAH QP。具有多年无菌制药行业工作经验，资深无菌制药技术专家。
He services as the deputy general manager of Shanghai Fosun Pharmaceutical Industry Development Co., Ltd., and also served as MAH QP.He is senior sterile pharmaceutical technology expert，and has many years of experience in the aseptic pharmaceutical industry.
谢红艳
谢红艳女士（药理学学士、药物化学硕士、高级工程师、执业药师）于1994年毕业于上海医科大学。1994~1996年在齐鲁制药从事药品生产、质量检验等工作，1996年起参与齐鲁安替比奥合资企业的筹建，并于1997年在意大利安替比奥制药总部接受药品质量控制和质量管理培训后担任齐鲁安替比奥制药有限公司QC实验室主管（1998-1999）、质量保证部部长（1999-2005）。2005~2007年担任齐鲁制药有限公司质量副总，2007~2017年担任齐鲁制药有限公司国际药政副总，2018年至今担任齐鲁制药集团副总裁，分管集团国际药政和集团质量内审，在原料药和制剂的质量管控、国际注册、国际认证等方面积累了丰富的实践经验。
Ms. XIE Hongyan(Master’s degree for pharmaceutical chemistry&Bachelor’s degree for pharmacology; senior engineer, licensed pharmacist) graduated from Shanghai Medical University in 1994. She worked in production and quality control department from1994 to 1996 and was involved in the construction of QiluAntibioticos Joint Venture from 1996 to 1997. She was trained for drug quality control and management in Antibioticos Italy in 1997. She worked as QC laboratory supervisor(1998~1999) and Quality Assurance Director(1999~2005) in QiluAntibioticos Pharmaceutical Co., Ltd. and was also responsible for the product registration in both China and other countries. Then she worked as Deputy General Manager for Quality(2005~2007)andDeputy General Manager for Overseas Regulatory Affairs(2007~2017) in Qilu Pharmaceutical Co., Ltd. She has been working as Vice President in QiluPharma Group( in charge of overseas regulatory affairs and internal quality audit of Qilu group) since 2018. She has working experiences for quality control and management, overseas registration and inspection for API and finished dosage forms in the pharmaceutical industry.
五、报名办法
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六、联系人和联络方式
（一）报名系统及会务咨询：
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（二）会议日程咨询：
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