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出自识林

2015-12-31 CPIER

Peking University Continuous Manufacturing Symposium
北京大学连续制造研讨会
The 1st Announcement 第1轮通知

Beijing, CHINA March 9-10, 2016
中国，北京 2016年3月9-10日

Objectives 目的

• Discuss recent development in pharmaceutical manufacturing innovation, including continuous processing

讨论制药生产创新方面的最新发展，包括连续制造

• Engage key academic, industry and regulatory stakeholders

吸引主要学术、产业和监管利益攸关方

• Describe different implementation approaches of continuous manufacturing for active pharmaceutical ingredients (APIs) and drug products

讲述原料药（API）和制剂连续制造的不同实现方式

• Discuss global regulatory and quality (GMP) expectations

讨论全球监管和质量（GMP）期望

• Present case studies illustrating a variety of implantation approaches

通过案例研究呈现多种实现方法

• Assess implementation progress, identify remaining gaps and propose appropriate solutions and next steps

评估实施进展，识别存在差距，提出相应解决方案和后续措施

• A white paper, co-authored by the symposium Steering Committee members and speakers, summarizing the symposium presentations, regulatory discussions and proposed next steps will be published after the symposium

研讨会指导小组成员和报告人共同撰写的白皮书将于研讨会后发布，总结研讨会报告和监管讨论，并提出下一步的建议

Symposium Steering Team 研讨会指导小组

• Qiang Zheng, Peking University, China, Co-Chair

北京大学，郑强，联席组长

• Moheb Nasr, GSK, USA, Co-Chair

美国葛兰素史克， Moheb Nasr，联席组长

• Ning Zhang, Center for Drug Evaluation （CDE）, CFDA, China

国家食品药品监督管理总局药品审评中心，张宁

• Sau (Larry) Lee, US FDA, USA

美国食品药品管理局（FDA），李守仁

• Jean-Louis Robert, EMA, UK

英国EMA， Jean-Jouis

• Michael Chang, Tofflon Science and Technology, China

中国东富龙科技，Michael Chang

• Weibing (Alex) Wang, Hisun Pharmaceuticals, China

中国海正药业，王卫兵

• Markus Krumme, Novartis, Switzerland

瑞士诺华制药，Markus Krumme

• Michael O’Brien, Pfizer, USA

美国辉瑞制药，Michael O’brien

• Mark Buswell, GSK, UK

英国葛兰素史克， Mark Buswell

Symposium Agenda Wednesday, March 9, 2016 研讨会日程，2016年3月9日，周三

Session Chair: Qiang Zheng, Peking University, China
主持人：郑强，北京大学，中国

08:00 – 08:45 Breakfast and Registration 早餐和注册

08:45 – 09:00 Symposium Introduction, Qiang Zheng – Peking University, China 研讨会介绍，郑强 – 北京大学

09:00 – 09:30 Drivers and Opportunities for Pharmaceutical Manufacturing Innovation, Mark Buswell – GSK, UK 制药生产创新的驱动和机遇，Mark Buswell – 英国葛兰素史克

09:30 – 10:00 Considerations on the Control Strategy for End-to End Coupled Processes, Markus Krumme – Novartis, Switzerland 全程耦合工艺控制策略的考虑，Markus Krumme – 瑞士诺华

10:00 – 10:30 Modularizing Continuous Manufacturing to Achieve Even Greater Flexibility and Value, Mike O’Brien – Pfizer, USA 模块化连续制造以获得更高灵活性和价值，Mike O’Brien – 美国辉瑞

10:30 – 11:00 Break间歇 11:00 – 11:30 Continuous Manufacturing of Immediate Release Tablets, Weibing (Alex) Wang – Hisun Pharmaceuticals, China 速释片剂的连续制造，王卫兵 – 中国海正药业

11:30 – 12:00 Spray Freeze Drying and Continuous Manufacturing, Michael Zhang – Tofflon Science and Technology, China 喷雾冷冻干燥和连续制造，Michael Zhang – 中国东富龙科技

12:00 – 13:00 Lunch 午餐

13:00 – 13:40 Regulatory and Quality Considerations of Continuous Manufacturing, Moheb Nasr – GSK and Jean-Louis Robert – EMA 连续制造的监管和质量考虑，Moheb Nasr – GSK和Jean-Louis Robert - EMA

13:40 – 15:00 Regulatory and Quality Considerations of Continuous Manufacturing, 连续制造的监管和质量考虑，

• US FDA Regulatory Perspective, Sau (Larry) Lee – US FDA, USA 美国FDA监管视角，李守仁 – FDA，美国
• EU Regulatory Perspective, EU Speaker (to be confirmed) 欧盟监管视角，欧盟演讲人（待确认）
• CFDA Regulatory Perspective, Ning Zhang – CDE, CFDA, China 中国食药总局监管视角，张宁 – CFDA药品审评中心，中国

15:00 – 15:30 Break 间歇

15:30 – 17:00 Panel Discussion (All speakers)小组讨论（所有报告人）

Symposium Agenda Thursday, March 10, 2016 研讨会日程，2016年3月10日，周四

Session Chair: Moheb Nasr, GSK, USA
主持人：Moheb Nasr，美国葛兰素史克

08:00 – 08:45 Breakfast and Registration 早餐和注册

08:45 – 09:00 Session Introduction, Moheb Nasr – GSK, USA 研讨会介绍，Moheb Nasr – 美国葛兰素史克

09:00 – 09:30 Implementing A Three Stage Continuous API Process to IG Grade API, Andrew Rutter – GSK, UK 实现三阶段连续API工艺到IG级API，Andrew Rutter – 英国葛兰素史克

09:30 – 10:00 Design of a Small Footprint Continuous API facility for Portfolio Commercialization, Paul Collins – Eli Lilly, USA 产品组合商业化的小型化连续API设施的设计 – 美国礼来

10:00 – 10:30 Break 间歇

10:30 – 11:00 Defining the Key Elements for a Drug Product Continuous Manufacturing Control Strategy, Hayden Thomas – Vertex, USA 确定药品连续制造控制策略关键因素，Hayden Thomas – 美国Vertex

11:00 -11:30 Implementing A Continuous Wet Granulation Process for Phase III Clinical Supply, Gurjit Bajwa – GSK, UK 实现供III期临床的连续湿法制粒工艺，Gurjit Bajwa – 英国葛兰素史克

11:30 – 12:15 Panel Discussion (Morning Speakers) 小组讨论（上午的报告人）

12:15 – 13:15 Lunch 午餐

13:15 – 13:45 Product Quality Improvements Achieved Through the Use of Continuous Manufacturing at Merck – Case Studies Covering Biologics and Solid Oral Dosage, Robert Meyer – Merck, USA 默沙东通过连续制造的使用获得产品质量改善 – 涵盖生物制品和固体口服制剂的案例研究，Robert Meyer – 美国默沙东

13:45 – 14:15 An Integrated Multi-Layer Approach to Control Strategy for Continuous DP Manufacturing, Paul Collins – Eli Lilly, USA 制剂连续制造控制策略的集成化多层次方法 – 美国礼来

14:15 - 14:45 Role of Enabling Technologies for Continuous Manufacturing, Pankaj Shah – BMS, USA 连续制造使能技术的作用，Pankaj Shah – 美国施贵宝

14:45 – 15:15 Control Strategy for Pharmaceutical Continuous Manufacturing – Overview and Case Study. Mojgan Moshgbar – Pfizer, USA 制药连续制造控制策略概览和案例研究，Mojgan Moshgbar – 美国辉瑞

15:15 – 15:30 Break 间歇

15:30 – 16:00 Validation Concepts in End-to-End CM, Yanxi Cain – Novartis, USA 全程连续制造中的验证概念 – 美国诺华

16:00 – 16:30 Conversion from Batch to Continuous Manufacturing: Challenges and Opportunities for Drug Product Continuous Direct Compression, Anthony Tantuccio – BMS, USA 从批生产到连续制造的转换：制剂连续直接压片的挑战和机遇 ，Anthony Tantuccio – 美国施贵宝

16:30 – 17:15 Panel Discussion (Afternoon Speakers) 小组讨论（下午的报告人）

Symposium Venue 研讨会场地

Sciences Auditorium, Zhong Guan Xin Yuan Building 1
Peking University, Beijing, China, 100871
北京大学中关新园1号楼，科学报告厅，中国北京，100871

Registration 注册

To register, please email us the above information. We will inform you whether we accept your registration within 48 hours. Please do not send the registration fee before your registration is accepted. The registration is completed after we receive your payment confirmation. The receipt for registration will be available at the symposium. 请将填妥的注册表电邮给会务组。我们将在48小时内通知是否接受您的注册。在接到我们正式通知之前一定请勿先付注册费。收到您的付款凭证扫描件后注册生效。注册费发票报到时领取。

Registration Fees 注册费

The registration fees cover symposium handouts, real-time translation headsets, continental breakfast, refreshment and lunch. 注册费含会议资料、同声传译耳机、简易早餐、茶歇和午餐。

Contact Information 联系信息

Peking University Continuous Manufacturing Symposium 北京大学连续制造研讨会
Tel: +8610-6275-4107
Email: cms@cpier.pku.edu.cn
Web: www.cpier.pku.edu.cn

参考酒店等信息请参见北京大学药物信息与工程研究中心网站www.cpier.pku.edu.cn