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  • 技术与法规大课堂

    1970/01/01 - 1970/01/01 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

      高级工程师 江苏中金玛泰医药包装有限公司副总经理 江苏省药品包装药用辅料协会常务理

      事




      朱银华

      博士,曾担任香港大学化学系NSFC-RGC合作项目研究助理;2013-2014年,作为主要成

      员参与协会标准YBX-2005-2014《药用胶塞生产质量管理规范》的起草工作;2017-2018

      年,作为企业代表参与《化学药品与弹性体密封件相容性研究技术指导原则(试行)》的起草讨论工作;2018年,作为企业代表参与协会标准《药包材生产质量管理指南GMP》的起草讨论工作。



      蔡荣

     上海市食品药品包装材料测试所副所长,主要从事食品药品包装材料技术、质量控制及标准

     制定工作。第一节食品国家安全标准审评委员会委员、国家食品药品监督管理局药品包装材

     料评审专家,上海市医药高级职称评审专家。



    俞辉

    国家食药监总局药包材审评专家,国家药典委委员,中国医药包装协会专家,浙江省医药包装行业协会秘书长。



     


     

     

     

      






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