本届论坛主题：聚焦国际法规最新动态·促进控制检测技术发展。热忱欢迎微生物领域的同仁，于2017年11月16-17日莅临苏州独墅湖世尊酒店论坛会场共同交流。
汇聚国内外法定机构、学术机构、监督检验机构、国内外制药企业的微生物专家以及学术带头人，共同研讨制药工业微生物的控制/检测技术、理念、法定标准的修订方向。从而促进中国制药行业微生物的整体能力提升，逐渐达到国际先进水平。
会议亮点
01
权威解读2020版药典进展
邀请国家药典委员会老师权威解读2020版《中国药典》微生物编制思路进展，微生物检验现状和发展方向；
02
国际主流药典解读
邀请国际主流药典USP/JP的专家，介绍微生物法规要求、修订以及相互协调；
03
药品GMP检查
邀请国内药品监督管理机构的资深检查员，介绍对药品生产企业的实验室管理与微生物检测法规符合性检查方向；
04
制药企业微生物控制
邀请国内外知名药企微生物控制与检测专家，分享无菌工艺、生物制药等关键控制点及控制技术；
05
微生物检测新技术
邀请工业界专家介绍培养基控制、自动检测的最新技术与高效率快速检测案例。
论坛主席
论坛名誉主席
张文周
原国家食品药品监督管理局副局长
论 坛 主 席
黄正明
中国医药教育协会会长
解放军第302医院药学部临床药理研究室主任
军事医药教育委员会主任委员
军事医学科学院博士生导师
中国科学院博士生导师
论坛主持人
崔京
上海博莱科信谊药业中国区质量总监
主持人
Compere
博莱科信谊中国区质量总监，负责公司质量体系的有效运行，并符合国内外的相关法规。崔京女士在灭菌验证以及洁净区环境控制方面有着丰富的经验。
在入职博莱科信谊之前，她是百特医疗中国制造的质量负责人，丽珠药业质量总监，百特以其参数放行而着称。
崔京女士参与国家局和中国药典会多个项目：参数分析，隔离器验证，也是原广东省药监局外聘无菌保证专家。崔京女士在中国药科大学获得药物分析硕士学位。
Ms jing cui ,the quality director of Braccosine is Successfully Manage Quality Department，be responsible effectiveness of quality system, safety & quality of product and conformance to internal & external regulations .She has rich experience in sterilization validation and environment control in cleaning room. Before joining Braccosine, she is the china manufacture quality head of Baxter which is famous for parameter release and quality director of Livzon. Ms jing cui took part in several projects initiated by SFDA&CHP, such as parameter release and isolator, meanwhile she is also an external sterility SME invited by Guangdong FDA. Ms jing cui received her doctor degree in Chinese pharmaceutical university , major in Pharmaceutical Analysis .
专场一、中国微生物法规编制与展望
China microbiology regulation expectation and supervision
2017年11月16日 A.M.
演讲嘉宾
许华玉
国家药典委员会
2020版《中国药典》微生物编制思路与进展
Microbial test method research on aerosol preparation and Pharmacopoeia revise progress
国家药典委员会业务综合处，主任药师。从事药品微生物工作已有三十多年，负责《中国药典》2005年版、2010年版、2015年版、2020年版微生物方面内容增修订工作。
General Affairs of Chinese Pharmacopoeia Commission，professor of pharmacy. More than 30 years’ experience in microbiology field. Beresponsible for Ch.P.2005，Ch.P.2010，Ch.P.2015 and Ch.P.2015 revising of microbiology part.
杨美成
上海市食品药品检验所副所长
气雾剂微生物检验方法研究与药典修订进展
Microbial test method research on aerosol preparation and Pharmacopoeia revise progress
上海市食品药品检验所副所长，博士/主任药师，国家药典委员会第十一届微生物专委会委员，CNAS评审组长，上海药学会药物分析专委会副主任委员，从事药物分析、微生物检测、质量管理、标准制订、检测方法研究等领域24年。
Member of Chinese Pharmacopeia Commission, 11th microbiology committee. 24 years experience in pharmaceutical and microbiology analysis, quality management, standard development and testing techniques study. Vice director of Shanghai Institute for Food and Drug Control, Leader Assessor of CNAS, Vice director of pharmaceutical Analysis Section of Shanghai Pharmaceutical Association.
王知坚
浙江省食品药品检验研究院副院长
2020版《中国药典》附录灭菌法修订进展
Revising progress on sterilization method of Ch.P. 2020
浙江省食品药品检验研究院副院长，国家药典委员会第十一届微生物专委会委员，兼任中国药学会浙江省分会药物分析专业委员会委员、微生物检验专业组组长、浙江省检验机构计量认证/审查认可评审员、浙江省药品GMP检查员等职。
Deputy dean of Zhejiang institute for food and drug control. member of Chinese Pharmacopeia Commission, 11th microbiology committee. Member of pharmaceutical analysis commission of Zhejiang Pharmaceutical Association. Microbiology group leader. The judge of metrology certification and accreditation for inspection institute. GMP inspector of Zhejiang FDA.
专场二、国际微生物标准协调与融合
International microbiology specification harmonization and integration
2017年11月16日 Ｐ.M.
Dr. Tirumalai
美国药典委员会
科学部门首要科学联络人
USP\EP\JP 协调、快速微生物检验技术现状与发展前景
USP/EP/JP harmonization and microbial rapid test method introduction
美国药典委员会（USP）科学部门首要科学联络人，Tirumalai博士负责USP微生物和毒理学专家委员会的科学事务联络工作。他与工业界、学术界、监管机构和其他科学组织紧密联系，致力于药典通则的开发和修订工作。Tirumalai博士代表USP出任PDA微生物和无菌保证专家工作组和委员会委会以及AAMI微生、无菌保证和生物相容性专家工作组成员。
Dr. Tirumalai is currently a Principal Scientific Liaison-General Chapters in the Science Division. He is the Staff Liaison to the USP General Chapters-Microbiology Expert Committee. He works with industry, academia, regulatory agencies and other external Science based organizations as the USP Expert Committee liaison in the development and revision of General Chapters in these areas. Dr. Tirumalai represents USP on PDA expert task forces and committees related to Microbiology and Sterility Assurance and on AAMI expert Working groups related to Microbiology, Sterility Assurance and Biocompatibility. Dr. Tirumalai's prior industry experience encompasses process and product research and development, transfer, and product manufacturing. He has a Ph.D. degree in Biochemistry. His postdoctoral work included studies on HIV and MuLV reverse transcriptases and bacteriophage lambda integrase. He has authored numerous publications and review articles. He is a frequent speaker at conferences and has taught Pharmacopeial Microbiology courses at numerous locations globally.
王晓明
PDA
PDA灭菌方法与验证概要
PDA sterilization method and validation overview
曾任美国美国注射药协会 （PDA）的Treasure
1987年毕业于首都医科大学医学系；
1987年至1989年，任北京红十字朝阳医院内科住院医；
1989年至1992年，在纽约瓦格纳学院（Wagner College） 学习微生物学，获得微生物细菌学硕士学位；
1990年开始，先后在美国SGS，强生公司和礼来公司从事微生物质量控制，质量管理工作。(2001 -2004),工业微生物协会新泽西分会副会长 （VP NJSIM，2003-2006）；
2006年至2014年，任纽约瓦格纳学院微生物系兼职教授。教授课程包括《公共卫生及临床微生物》、《食品、工业及应用微生物》、《高级细菌生理学》以及《病毒学》等课程；
2015年2月，被礼来公司总部派到礼来苏州制药有限公司无菌胰岛素灌装项目负责无菌保障。
Xiaoming Wang MD, MS Graduated from Capital Medical University in 1987. Worked in Beijing Red Cross Chaoyang hospital as a resident in internal medicine department until 1989. From 1989 to 1992, studied in Wagner College in New York and owned Master of Science degree in Bacteriology. Starting from 1990, worked QA/QC Microbiology department of biotech/pharmaceutical companies including SGS, Johnson & Johnson, Eli Lilly and Company. Used to be Treasure of PDA Metro Chapter (2001 -2004) and Vice Chairperson of Society of Industrial Microbiology NJ session (NJSIM) (2003 – 2006). Teaching at Wagner College as an adjunct professor from 2006 to 2014. Courses taught included “Clinical and public health microbiology”, “Food, industrial and applied microbiology”, “Advanced Microbial Physiology” and “Virology”. Starting from Feb, 2015, assigned to Suzhou Insulin Filling line as a Microbiology Consultant responsible for Sterility Assurance.
Dr. Tsuguo Sasaki
日本药典委员会
无菌保证委员会主席
JP微生物检测与控制理念
Microbial test and control concept in JP
日本药典委员会（JP）无菌保证委员会主席，参与了所有微生物和制药用水的编写，毕业于东京大学并获得博士学位。
1972至2008年，他就职于NIID（日本传染病研究所）生物制品控制部。在此期间的1983至1984年，他在巴斯德研究所担任研究员。离开NIID后，
2008至2013年，他就职于PMDA（日本医药品医疗器械管理局）担任GMP专家。目前，他是武蔵野大学药物科学的客座教授，也是一些制药企业的技术顾问。
1992年起，他担任ISO/TC198（医疗用品的灭菌）/WG3（湿热灭菌）、WG8（微生物检测）和WG9（医疗用品的无菌生产）的委员。
Dr. T. Sasaki obtained his Ph.D. from Tokyo University. In 1972, he started his career as a microbiologist in the Department of Biologics Control of the National Institute of Infectious Diseases (NIID), Tokyo (1972-2008), and was a research fellow of the Institute of Pasteur, Paris (1983-1984). After retirement the NIID, he worked at the Pharmaceuticals and Medical Devices Agency (PMDA) as GMP Expert for 5 years (2008-2013). He is now guest professor of Musashino University, Faculty of Pharmaceutical Sciences, as well as GMP Technical Advisor of some pharmaceutical companies.
From 1990 until 2015 he was a member of the Japanese Pharmacopoeia, and joined in the preparation of all microbiological and water chapters currently available as Chair of the Sterility Assurance Subcommittee and Chair of the Pharmaceutical Water.
From 1992, he is active member of ISO/TC198 (Sterilization of health care products)/WG 3 (Moist heat sterilization), WG 8 (Microbiological tests), and WG 9 (Aseptic processing of health care products).
专场三、国际检测新技术解析与应用
International microbiology new technology analysis and application
2017年11月17日 A.M.
付秋雁
上海药品审评核查中心
药品微生物污染的风险管控
Risk management of drug microbial contamination
上海药品审评核查中心药品GMP资深检查员，国家级检查员，质量工程师，执业药师。她主要负责药品生产企业的法规符合性检查工作，拥有十五年的药品生产质量监督和管理经验，尤其在无菌药品、生物制品、血液制品领域有着丰富的检查经验。她曾参与《无菌药品GMP检查指南》、《生物制品一次性反应器应用》等课题的研究，并多次参加WHO疫苗检查培训、WHO预认证检查培训，及血液制品国际高峰论坛等。她在加入ShFDA之前，曾从事药品研发和质量管理工作，毕业于中国药科大学生物制药专业学士学位，华东理工大学工程硕士项目管理专业在读。
Fu qiuyan, senior GMP inspector at Center for Drug evaluation and Inspection of Shanghai FDA, national inspector, quality engineer, licensed pharmacist.She responsible for drug manufacturer compliance review, with fifteen years of experience in drug managerment and administration, especially for sterile drugs, biological products and blood products.She took part in several research projects including “GMP Inspection Guideline for Sterile Drug Products”, "Application of Disposable Reactor for Biological Products" and others,attended WHO vaccine inspection & WHO PQ training,and took part in Bioplasma World Asia 2016,etc.Prior to joining ShFDA,she engaged in drug research and development and quality management, received bachelor's degree of biopharmaceutics at China Pharmaceutical University, master candidate of project management at East China University of Science and Technology.
Derek Lancashire
BD全球业务总监
培养基质量控制的生命周期
Quality control of microbiology media in whole life cycle
BD全球业务总监，Derek在微生物培养基开发，质量控制和运营方面拥有丰富的经验，在加入BD之前，Derek 就职于GIBCO实验室，作为实验室主管负责领导团队优化培养基的配制及性能提升，有着丰富的经验。Derek曾在着名培养基厂商DIFCO公司担任实验室质量控制主管和生产经理。Derek担任全球业务总监之前，他曾担任美国BD工业团队总监，专注于制药环境监测和无菌检测。
Derek毕业于英国的斯劳学院和美国威斯康星大学。
Derek Lancashire serves as World Wide Business Director for BD in Diagnostic Systems Microbiology Division in Sparks Maryland. Derek has extensive experience in Microbiology Media development, Quality control and Operations, prior to his time at BD Derek was the Laboratory supervisor at GIBCO Laboratories in the media formulations lab at which he led a team in optimizing growth performance characteristics of media formulations. Derek also previously worked at DIFCO laboratories as Quality Control Supervisor and Manufacturing Manager. Prior to Derek’s position as World Wide Business Director he was the Director of Sales for the BD Industrial team in the US focused on the Pharmaceutical market and specifically Environmental Monitoring and Sterility Testing. Derek studied at Slough College in the UK and at the University of Wisconsin, Platteville.
蒋惠迪
Charles River Laboratories
大中华区执行总监
细菌内毒素光度测定法解析
Endotoxin quantitative test method introduction and trouble shooting
Charles River Laboratories Microbial Solutions大中华区执行总监，负责中国大陆和台湾地区所有Microbial Solutions及其合资的湛江安度斯生物有限公司的运营和拓展。在细菌内毒素检测、微生物检测及鉴定领域具有广泛的经验, 涵括化学配方, 技术服务、 质量体系, 美国与亚洲销售管理。她拥有分析化学硕士学位。
Ms. Wendy Chiang serves as the Managing Director of Microbial Solutions, Greater China Region at Charles River Laboratories. She oversees the development of all Microbial Solutions brands in China and Taiwan including the operation of Charles River joint venture Zhanjiang A&C Biological Ltd. In the areas of bacterial endotoxin testing, microbial detection and identification, Ms. Chiang’s extensive experiences span from formulation chemistry, technical service, quality systems and sales management in the US and Asia. She holds a master’s degree in analytical chemistry.
蔡辉博士
药明生物质量控制部高级主任
生物药生产过程中的微生物控制
Microbial control in biological product processing
蔡辉毕业于美国威斯康星大学麦迪逊分校，并获得微生物学博士学位。现任药明生物质量控制部高级主任，是药明生物无锡生产厂房商业QC部和微生物以及环境监控团队负责人。她拥有丰富的生物药的分析方法开发及验证经验，推动多项技术改进，支持内部和外部的分析方面的需求。她是药明生物FDA PLI准备团队核心成员，评估和督促微生物控制策略与规程的改进，使厂房与工艺的微生物控制处于可控状态。在今年7月的FDA PLI检查过程中做出突出贡献，微生物环境监控相关缺陷项几乎为零。
在加入药明生物之前，先后就职于美国PPD和Bristol-Myers Squibb，从事生物药分析方法的开发和验证工作。
Dr. Hui Cai serves as Senior Director of Quality Control at WuXi Biologics, responsible for Commercial QC and microbial control of WuXi manufacturing facility. She has extensive experiences in analytical method development and validation for biologics, promoting technology improvement and providing internal and external analytical supports. She is one of the core members from the FDA PLI preparation team, responsible for evaluation and execution of microbial control strategies, to ensure that the manufacturing facility is under control. She made significant contributions during the FDA PLI this July, with minimal observations on microbiology/environmental monitoring. Prior to joining WuXi Bioloigics, Dr. Cai worked at PPD and Bristol-Myers Squibb in US, on development and validation of analytical methods for biologics. Dr. Cai received her Ph.D. in Microbiology from the University of Wisconsin – Madison.
专场四、国际微生物标准协调与融合
International microbiology specification harmonization and integration
2017年11月17日 Ｐ.M.
徐敏凤
上海市食品药品包装材料测试所副所长
制药过程中湿热灭菌工艺的验证
moist heat sterilization process validation in pharmaceutical industry
从事医药行业质量管理30多年，从事医药及食品，化妆品，电子，兽药等各类生产环境的监测和验证，医药用冻干机和灭菌器等设备验证和工艺验证等工作。
是洁净检测国家标准GB/T 16292-16294《医药工业洁净室（区）悬浮粒子、浮游菌和沉降菌的测试方法》项目负责人和主要起草人，《水浴式灭菌器选型技术需求》项目负责人和起草人，翻译出版了有关灭菌的专着《湿热灭菌工艺的验证》。参与编写有关洁净室监控和灭菌验证相关内容的大学教材。
目前受聘为：
国家食品药品监督管理局高级研修学院客座讲师；
农业部兽药GMP特聘授课讲师；
检验检测机构资质认定评审员。
Worked on pharmaceutical industry quality assessment for 30+ years. Monitored and validated various production environment including pharmaceuticals, food, cosmetic products, electronics and veterinary medicine production. evaluated equipment validation and process validation of freeze drying machine and sterilizer. Composed collaboratively and administered the project of “Test method for airborne particles, microbe and settling bacteria in clean room(area) of the pharmaceutical industry”, which is the national standard 'GB/T 16292-16294' of test of clean area. Composed and administered the project of “Technical requirements for type selection of water bath sterilizer”. Translated and published the monograph of sterilization “Thermal Validation in Moist Heat Sterilization”. Compiled college-used textbooks about supervision of clean room and validation of sterilization. Currently employed as guest lecturer by China Food & Drug Administration Institute of Executive Development, also as GMP instructor specialized in veterinary medicine by Ministry of Agriculture, and as inspectors authorized by Inspection and Certification Agency.
Ahmad Tarek
礼来公司技术服务和材料科学部无菌保障部主管
无菌保障与控制
Sterility Assurance and Control
礼来公司技术服务和材料科学部无菌保障部主管，特瑞克先生在QC 微生物，制药业的生产和无菌保障方面都有很大的见长。他2004年毕业于埃及开罗大学制药科学专业，获学士学位，并于2007年获美国大学（于开罗）MBA学位。
特瑞克先生于2007年受顾于礼来埃及公司。之前在BMS微生物实验室工作。2014年被派到中国主持无菌保障。
Mr. Ahmad Tarek: Associate Director Sterility Assurance Technical Services/Material Science (SA-TS/MS) of Eli Lilly and Company.
He has rich experience in QC Microbiology, Pharmaceutical Operations and Sterility Assurance. Tarek graduated from Cairo University in Egypt with Bachelor degree in Pharmaceutical Sciences in 2004 and Masters in Business and Administration from American University in Cairo in 2007.
Tarek worked in Bristol Myer Squibb as QC Microbiologist before Lilly in 2007. He is assigned to China from 2014 as SA leader.
张震
上海复旦张江生物医药股份有限公司
药品生产洁净环境的微生物监控
Clean room environmental monitoring
上海复旦张江生物医药股份有限公司QA经理，是复旦张江FDA项目组核心成员之一。毕业于上海医科大学，先后任职于上海先灵葆雅制药有限公司，上海勃林格殷格翰药业有限公司以及通用电气药业（上海）有限公司微生物实验室。
曾为上海勃林格殷格翰药业有限公司创立微生物实验室并组建微生物团队；
在通用电气药业有限公司时曾领导微生物团队数次顺利通过无菌产品的FDA及欧盟检查认证。
在制药行业微生物方面积累有近15年的工作经历，对无菌生产和微生物实验室的管理，洁净车间的微生物控制有独到的见解和丰富的实践经验。
Serves as QA Manager, Ms Julie Zhang is the core member of FDA project team in Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. She was graduated from Shanghai Medical University, and had working experience in several microbial laboratory of pharmaceutical companies, such as Shanghai Schering-Plough Pharmaceutical Company, Shanghai Boehring-Ingelheim Pharmaceutical Company and GE Healthcare (Shanghai)Co., Ltd. She set up a microbial laboratory and trained the microbial team for Boehring-Ingelheim. Acted as the microbial laboratory manager in GE Healthcare, she led the microbial team passed FDA and EU audits for sterile products for several times. With more than 15 years’ in pharmaceutical company, she has fruitfully experience in microbial laboratory and clean room control in sterile production.
IDMF2016 第一届论坛精彩回顾
IDMF2016 论坛会场
IDMF2016第一届高峰论坛，主题以药品微生物检验、生产过程微生物控制为主题，来自国内外16位制药微生物领域专家到会演讲，共同交流和探讨微生物技术发展的理念、趋势、方向。论坛的成功举办，必将对我国药品微生物检验与控制工作的发展，相关科研与应用水平的提高，专业人才的培养产生积极的影响。
中国食品药品检定研究院官网 IDMF2016简讯：
http://www.nicpbp.org.cn/CL0834/8810.html
IDMF2016 第一届论坛领导致辞
2016年11月15日至16日，IDMF2016第一届国际药品微生物检验控制高峰论坛在杭州召开。本次论坛由中国医药教育协会主办，中国食品药品检验研究院、国家药典委员会、浙江省食品药品检验研究院等单位共同支持举办。来自全国药检机构、制药企业、大专院校450余人参加本次论坛。组委会邀请到原国家食品药品监督管理局张文周副局长、中国食品药品检定研究院张志军副院长、浙江省食品药品监督管理局陈时飞副局长莅临指导并致辞。
