中国医药包装协会

时间/地点：2018年9月1日（Sep 1）/ 会议室9（M9）

会议日程：

8:30-9:30

How to select packaging for parenterals and biologics

Charbel Tengroth , Principal Consultant of Tengroth Consulting AB

9:30-10:00

通过物联网的数据采集和追踪技术，促使患者坚持服用有针对性的药物

To Enhanced Data Capturing and Tracking Technology for Patient Adherence in a Targeted Drug

Miae Yim, Marketing Manager, BASWEN

10:00-10:10

交流时间/Break

10:10-11:00

Why Connectivity and How to Get There

Arnaud Guillet , Business Development Director ,BIOCORP

11:00-11:30

中国药包材发展概况

张凌超国家药品监督管理局药化注册司

11:30-12:00

《药包材登记资料要求（征求意见稿）》解读
Interpretation of Registration requirements for pharmaceutical packaging materials (draft for comments)

马玉楠药品审评中心专家

12:00-13:00

午餐

13:00-13:30

药包材名词术语课题汇报
Report on terminology of pharmaceutical packaging materials

俞辉浙江省食品药品检验研究院药品包装材料检验所所长

13:30-14:00

基于最新质谱与数据解析技术的可提取物与浸出物分析工作流程
Extractable and leachable analysis workflow based on the latest mass spectrometry and data analysis techniques

金利捷赛默飞世尔科技(美国)，色谱质谱部

14:00-14:30

玻璃包材登记资料提交案例分享

Submission Requirements for Registration Materials of Pharmaceutical Glass Packaging & Cases Sharing

姚文震江苏省医药包装药用辅料协会副秘书长

14:30-14:50

规范药包材生产质量管理，引领行业发展
Association Standard for Pharmaceutical packaging GMP, Improve Quality Management of Supply Chain

何建忠江苏中金玛泰医药包装有限公司副总经理

14:50-15:10

《药包材生产质量管理指南GMP》协会标准：服务供应商审计
Association Standard for Pharmaceutical packaging GMP：Guide for Supplier Audit

朱银华江苏华兰药用新材料股份有限公司

15:10-15:30

交流时间/Break

15:30-15:50

中国中性硼硅玻璃的发展
The development of neutral borosilicate glass in China

王焕一沧州四星玻璃股份有限公司

15:50-16:20

直接接触药品包装系统与组件的命名要求

杨会英中国食品药品检定研究院专家

16:20-16:50

欧盟食品包装标准化工作的趋势及思考
The trend and thinking of EU food packaging standardization

蔡荣上海市食品药品包装材料测试所副所长

演讲嘉宾：

Arnaud Guillet

Currently Business Development Director at BIOCORP, in charge of seeking

partnerships with pharma companies or disease management platforms to

customize BIOCORP’s existing range of connected devices in the fields of

injection and respiratory, and exploring opportunities for on demand programs. Before joining BIOCORP, he was a consultant for a firm specialized in Healthcare. He also worked in the pharma industry for Sanofi, and in the health insurance sector at AXA. In terms of academic background, he graduated from HEC, a European business school, with a major in strategy. He also has a degree in political sciences and public affairs.

姚文震

现任江苏省医药包装药用辅料协会副秘书长，双峰格雷斯海姆公司副总经理。2005年加入

双峰格雷斯海姆公司并先后担任镇江公司副总经理和丹阳公司丹阳工厂经理，长期负责产品

法规及药包材注册工作，在药用玻璃生产和质量技术研究以及药包材注册工作方面具有丰富的经验。2016年，开始担任江苏省医药包装药用辅料协会副秘书长，负责协会交流合作项目。

Miae, YIM

Yim has experience in the marketing of IoT products in heatthcare field, her

profound experience and knowledge in early stage development to the next stage

by helping development to prototype and commercial manufacturing.In her current role as marketing director, Yim is responsible for drug delivery technologies to support business bringing innovative technology, in Iot device heathcare field. Yim and her colleagues will dedicate to IoT healthcare industry by continuous research and development to solve problems , to improve patient adherence providing global level products.

Charbel Tengroth

Charbel has a strong scientific background holding a PhD in physics from Chalmers

Institute of Technology and a post-graduate research positions at Princeton

University and AstraZeneca R&D, which has given him the ability to very quickly get to the core of complex issues. Over the years Charbel has contributed to the success of a wide range of pharmaceutical products and medical devices such as Prevnar 13, Genotropin, Depo-Provera/Sayana, and the DAI and Molly families of injection devices.

Kate Comstock 金利捷

Kate Comstock is a Senior Marketing specialist in Pharma and Biopharma

Marketing at Thermo Fisher Scientific, Life Sciences Mass Spectrometry Division in

San Jose, CA., USA. Kate joined Thermo in 2010 to support new product development and small molecule applications in the pharmaceutical industry and extractables & leachables analysis using high resolution mass spectrometry.

何建忠