弗戈制药工程国际论坛 2012论坛日程
文章来源：弗戈工业在线
发布时间：2012-04-12
| 6月27日 | 听众注册报到 | |
| 09:00~17:00 | 听众注册报到 | |
| Audiences registered | ||
| 6月28日上午 | 开场致辞 | 演讲人 |
| 08:50~09:00 | 主办方致辞 | 肖捷，PROCESS出版人 |
| The host unit delivers speech | Lucy Xiao, PROCESS China Publisher | |
| 09:00~09:10 | 大会主席致辞 | 任德权，国家食品药品监督管理局原副局长 |
| Forum Chairman delivers speech | Ren Dequan, SFDA | |
| 09:10~09:20 | 制药工程国际论坛的宗旨和目标 | 孙小兵,PROCESS《流程工业》高级顾问 |
| The purpose to hold Vogel International Pharmaceutical Engineering Forum | Sun Xiaobing, Senior Consultant of PROCESS China | |
| 无菌制剂分论坛 Aseptic preparations（6月28~29日） | ||
| 6月28日 | 演讲题目 | |
| 9:30~10:20 | 2010版药品GMP认证常见问题及分析 | 张华，上海市食品药品监督管理局认证审评中心首席认证员兼GMP部部长 |
| Common problems and analysis of 2010 GMP certification | Zhang Hua,Shanghai Food and Drug Administration | |
| 10:20~11:00 | 新法规下无菌药品质量管理 | 沈菊平，江苏正大天晴药业股份有限公司质量总监 |
| The quality management of sterile products in event of new regulations | Shen Juping, Quality Director, Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd | |
| 11:00~11:20 | 茶歇 | |
| 11:20~12:00 | 冻干工艺的质量管理和风险控制 | 郑金旺，上海东富龙科技股份有限公司技术总监 |
| Quality management and risk control over freeze-drying process | Zheng Jinwang, Technical Director, Shanghai Tofflon Science and Technology Co.,Ltd | |
| 12:00~14:00 | 午餐 | |
| 14:00~14:40 | 洁净公用工程系统的质量风险与解决方案 | 张功臣，奥星公司水系统业务单元技术经理 |
| Quality management and risk control over the clean public engineering system | Philip Zhang, Technical Manager of Liquid Process System Engineering, Austar Group | |
| 14:40~15:20 | 新版GMP对除菌滤芯的验证要求之——细菌挑战实验与溶出物/析出物评估 | 武富，杭州科百特过滤器材有限公司验证中心 |
| The new GMP requirement of aseptic filtration—bacteria challenge experiment and dissolution /deposition test evaluation | Wu Fu, Hangzhou Cobetter Filtration Equipment Co., Ltd | |
| 15:20~15:40 | 茶歇 | |
| 15:40~16:20 | 讨论 | |
| 6月29日 | 演讲题目 | |
| 9:00~9:40 | 无菌原料药的工艺模拟 | 邓海根，中国医药设备工程协会高级顾问 |
| Process Simulation of sterile APIs | Deng Haigen, Senior Consultant，China Pharmaceutical Association of Plant Engineering | |
| 9:40~10:20 | ICHQ9原则在无菌工艺生产中的实际应用 | 陈柏林，中国制药装备行业协会顾问 |
| Application of ICHQ9 principle in aseptic processes | Chen Bolin, Domestic GMP expert | |
| 10:20~10:40 | 茶歇 | |
| 10:40~11:20 | 无菌生产中洁净室的环境监测 | 国内知名微生物污染控制专家 |
| Cleanroom environment monitoring in aseptic production | Domestic famous microbial pollution control expert | |
| 11:20~12:00 | 制药用水系统的设计要点 | 王伟，上海净泽洁净设备有限公司营运经理 |
| The main points of designing pharmaceutical water system | William Wang, General Manager , Winatech Process Engineering( Shanghai)Co.,Ltd | |
| 12:00~14:00 | 午餐 | |
| 14:00~14:40 | 无菌生产工艺和设备选择 | Anwarul Haque，奥星验证咨询服务部验证总监 |
| Steril manufacturing process and equipment selection | Anwarul Haque，Validation Director，Austar Validation Consultancy Service Department | |
| 14:40~15:20 | 欧洲制药业先进的物流及配送系统 | Harald J. Geitz, 德国吉欧项目管理咨询有限公司董事总经理 |
| Advanced logistics and distribution system in European pharmaceutical industry | Harald J. Geitz, Managing Director, i+o Industrieplanung + Organisation GmbH & Co. KG | |
| 15:20~16:20 | 讨论 | |
| Discussion | ||
| 固体制剂及原料药分论坛Solid preparations and API（6月28~29日） | ||
| 6月28日 | 演讲题目 | 演讲人 |
| 9:30~10:10 | 从工业界视角看中国CMC法规环境现状 | 桂敏, 博士, 百时美施贵宝公司, 全球法规科学部, 亚太CMC, 中国CMC, 运营及法规策略管理总监; RDPAC药学专业组主席; ISPE药政委员会资深成员 |
| Current status of CMC regulatory environment in China from industry perspectives | Min Gui, PhD, Director, CMC Asia Pacific, China CMC, Operation & Regulatory Strategy Management, Global Regulatory Sciences, Bristol-Myers Squibb; Chair of RDPAC CMC Focus Group; Member of ISPE Regulatory Affair Committee | |
| 10:10~10:50 | 如何为药品构建一个稳健的质量体系 | ISPE基准指南《口服固体制剂》译者 |
| How to build a robust quality system for pharmaceutical product? | The translator of Oral Solid Preparation, ISPE Baseline Guide | |
| 10:50~11:10 | 茶歇 | |
| 11:10~12:00 | 固体制剂产品设计和设施设计中的质量风险管理 | 雷继峰，上海安必生制药技术有限公司CEO |
| Quality risk management in OSD product design & facility design | Lei Jifeng, Founder and CEO of Shanghai Anbison Lab. Co. Ltd | |
| 12:00~14:00 | 午餐 | |
| 14:00~14:40 | 溶出度技术提高固体制剂的内在品质 | 谢沐风，上海市食品药品检验所 |
| The dissoluting technology improves the intrinsic quality of the solid preparation | Xie Mufeng, SIFDC | |
| 14:40~15:20 | 实例分享-新建厂房项目验证的组织及实施 | 赵云霞，发泰（天津）科技有限公司质量部经理 |
| Case study-organization and implementation of new building project verification | Zhao Yunxia, Validation Manager, Pharm-Tech | |
| 15:20~15:40 | 茶歇 | |
| 15:40~16:20 | 中药提取工艺中的节能设计 | 钱潍生，山东省医药工业设计院前院长 |
| Energy saving design of the traditional Chinese medicine extraction technology | Qian Weisheng, Former Director, Shandong Province Design Institute of Pharmaceutical Industry | |
| 16:20~17:00 | 传统中药质量控制方法在国际化道路上的探索 | 叶正良，天津天士力之骄药业有限公司董事长兼总经理，天士力集团FDA-CMC项目总监 |
| Exploration of traditional Chinese medicine quality control methods in the internationalization way | Ye Zhengliang, Chairman & General Manager of Tianjin Tasly Pride Pharmaceutical Co., Ltd., Project Director of the FDA-CMC Project of Tianjin Tasly Group Co., Ltd | |
| 17:00~18:00 | 讨论 | |
| Discussion | ||
| 6月29日 | 演讲题目 | 演讲人 |
| 9:00~9:40 | 新版GMP对工艺设计、验证的新要求 | 王彦忠，中美史克制药有限公司质量部验证经理 |
| The new requirements to the process design and validation by the new version of Chinese GMP | Wang Yanzhong, Quality Validation Manager, Tianjin Smith Kline & French Laboratorles Ltd | |
| 9:40~10:20 | 自动化与精益生产在欧美及印度的发展 | 赵明，英国迈康有限公司中国区总经理 |
| The trend of automation and lean manufacture in India and Europe | Zhao Ming, China General Manager, British Matcon Co.,Ltd | |
| 10:20~10:40 | 茶歇 | |
| 10:40~11:20 | 在封闭的系统中进行制剂的生产 | AZO安卓物料自动化系统（天津）有限公司 |
| Preparation production In closed system | AZO Ingredients Automation System (Tianjin) Co., Ltd | |
| 11:20~12:00 | 制药工业的清洁消毒 | 白佳，艺康集团全球副总裁/艺康大中华区食品饮料事业部总经理 |
| Clean and disinfection in pharmaceutical industry |
James Bai, Vice President & Managing Director of F&B + Water, Energy, Waste solution，Ecolab Inc | |
| 12:00~14:00 | 午餐 | |
| 14:00~14:40 | 高效的固体制剂包装方案——多道枕式包装的应用 | 王曦梅，发泰（天津）科技有限公司技术副总经理 |
| Efficient solid preparation packaging solution—application of multi-channel pillow packaging | Wang Ximei, Vice Technical Manager, Pharm-Tech | |
| 14:40~15:20 | TOC应用于制药设备的清洁验证 | 谷雪蔷，GE发电设备与水处理集团分析仪器市场及应用经理 |
| Application of total organic carbon (TOC) in the equipment cleaning validation | Paulina Gu, Marketing and Application Manager of Analytical Instruments, GE General Electric (China) Co., ltd | |
| 15:20~16:20 | 讨论 | |
| 信息化和自动化分论坛 Informatization and Automation（6月28~29日上午） | ||
| 6月28日 | 演讲题目 | 演讲人 |
| 9:30~10:10 | 药品电子监管 | 王迎利，国家食品药品监督管理局副处长 |
| Drug electronic supervision | Wang Yingli, Deputy Director ,State Food and Drug Administration | |
| 10:10~10:50 | 从一体化工程设计到一体化运营 | 赵准，西门子工业软件（上海）有限公司 COMOS 产品经理 |
| From Integrated Engineering to Integrated Operation | Zhao Zhun, Product Manager COMOS, Siemens Industry Software (Shanghai) Co., Ltd. | |
| 10:50~11:10 | 茶歇 | |
| 11:10~12:00 | 自动化与信息化——确保药品质量的必经之路 | 汤继亮，上海医药工业研究院研究员 |
| Informatization and Automation—The necessary way for ensuring the quality of medicines | Tang Jiliang, Researcher, Shanghai Institute of Pharmaceutical Industry | |
| 12:00~14:00 | 午餐 | |
| 14:00~14:40 | Fade or flourish？Rethinking the role of life sciences companies in the healthcare ecosystem | 李南平，IBM大中华区医疗与生命科学商业拓展总监 |
| Fade or flourish？Rethinking the role of life sciences companies in the healthcare ecosystem | Lisa Li ，Healthcare (and Life Sciences) Strategy and Business Development Executive，IBM GCG Public Sector | |
| 14:40~15:20 | DCS系统在新型头孢无菌原料药项目中的应用 | 王晓松，ABB中国过程自动化业务部控制技术本地业务单元工程经理 |
| Application of DCS system in the new cephalosporin aseptic API project | Wang Xiaosong ，Engineering Manager，Control Technologies，Process Automation division，ABB China Ltd | |
| 15:20~15:40 | 茶歇 | |
| 16:00~16:40 | 仓储区域的温度分布研究和验证 | Bruce McDuffee, 维萨拉生命科学事业部全球市场部经理 |
| Validation temperature mapping for storage areas | Bruce McDuffee, Global Marketing Manager, Life Science Division, Vaisala | |
| 16:40~17:20 | 人机界面HMI 在制药工业中的应用 | 管磊，倍加福（北京）过程自动化控制设备有限公司 |
| HMI Solutions for pharmaceutical production | Guan Lei, Pepperl+Fuchs (Beijing) Process Automation Control Equipment Co., Ltd | |
| 17:20~18:00 | 讨论 | |
| 生物制剂分论坛 Biopharmaceutical（6月29日） | ||
| 6月29日 | 演讲题目 | 演讲人 |
| 9:00~9:40 | 在中国设计及建设现代化单克隆抗体项目的经验分享 | David Liu，生物技术经理，PM Group |
| Sharing experience in designing & building up modern mAb facility in China | David Liu, Biotechnology Manager, PM Group | |
| 9:40~10:20 | GEP规范在制药工程项目中的运用探讨 | 冯力，上海生物制品研究所有限责任公司工程部副经理 |
| Application of GEP in pharmaceutical engineering projects | Feng Li, Deputy Manage of Engineering Department, Shanghai Institute of Biological Products Co., Ltd | |
| 10:20~10:40 | 茶歇 | |
| 10:40~11:20 | 生物制剂厂房建设经验分享 | 陈凯东,日挥株式会社，事业推进项目本部，都市基础设施开发部，生命科学组担当课长 |
| Sharing experience in biopharmaceutical factory's design & building up | Chen Kaidong, Section Supervisor of Life Science Team, Urban Infrastructure Development Department, Business Promotion Project Department, JGC Corporation | |
| 11:20~12:00 | 过氧化氢灭菌系统在无菌生产系统中应用 | 刘前进，奥星集团设备与工艺系统事业部销售经理 |
| The application of hydrogen peroxide sterilization system in sterile production system | Liu Qianjin, Region Sales Manager, Equipment & Process Systems Business Divisions, Austar Group | |
| 12:00~14:00 | 午餐 | |
| 14:00~14:40 | 无菌制剂生产中的隔离技术 | 吴文蕾，上海东富龙爱瑞思科技有限公司技术部经理 |
| Barrier isolation technology in the pharmaceutical aseptic processing | Wu Wenlei, Technical Manager, Shanghai Tofflon AIREX Science and Technology Co.,Ltd | |
| 14:40~15:20 | 疫苗工艺验证与质量提高 | 王辉，总经理助理兼质保部经理,北京天坛生物制品股份有限公司 |
| Vaccine process validation and quality improvement | Wanghui, General ManagerAssistant & Quality Assurance Manager, Beijing Tiantan Biological Products Co.,Ltd |
|
| 15:20~16:20 | 讨论 | |
| Discussion | ||
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