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  • 给药系统中的高端玻璃容器

    1970/01/01 - 1970/01/01 协会


    时间/地点:2018年9月1日上午(Sep 1 AM)/  会议室3(M3)

    合作单位:   

                   

    内容介绍:

           制药生产工艺的成功需要考虑到很多方面。这个研讨会将突出不同的观点:从法规角度,尤其侧重于脱片问题的容器生产和给药系统中容器的匹配性到先进的检测技术。
           Several aspects need to be considered for the success of pharmaceutical process manufacturing. This workshop will highlight the different points of view: from the regulatory perspective, the container manufacturing with particular focus on delamination issue and the container integration into a drug delivery system up to advanced inspection technologies.
     
    演讲题目:
           1. 国际玻璃委员会 - 技术委员会 12“药用玻璃”脱片报告  演讲嘉宾:Daniele Zuccato
               Results of the ICG-TC 12 “Glasses for Pharma” on delamination. – Daniele Zuccato
           2. 高级药用玻璃容器和给药系统  演讲嘉宾:Paolo Golfetto
               Advanced glass containers for pharma and Drug Delivery Systems  - Paolo Golfetto
           3. 注射剂用视觉检测系统   演讲嘉宾:Gaetano Baccinelli
               Advanced optical inspection systems for injectables - Gaetano Baccinelli
           4. 欧盟/美国/日本关于注射类组合产品的法规趋势  演讲嘉宾:Andrea Salmaso

               Regulation trend of European/US/Japan  Injectable Combination Products – Andrea Salmaso

    日程安排:

    8:30-8:40


    开场致辞            
    Opening speech

    演讲嘉宾:Fabiano Nicoletti 博士



    8:40-9:20


    国际玻璃委员会 --技术委员会 12“药用玻璃”脱片报告
    Results of the ICG-TC 12 “Glasses for Pharma” on delamination

    演讲嘉宾:Daniele Zuccato



    9:20-10:00


    高级药用玻璃容器和给药系统

    Advanced glass containers for pharma and Drug Delivery Systems  

    演讲嘉宾:Paolo Golfetto



    10:00-10:20


    茶歇  Tea break



    10:20-11:00


    注射剂用视觉检测系统
    Advanced optical inspection systems for injectables

    演讲嘉宾:Gaetano Baccinelli



    11:00-11:40


    欧盟/美国/日本关于注射类组合产品的法规趋势
    Regulation trend of European/US/Japan  Injectable Combination Products

    演讲嘉宾:Andrea Salmaso




    11:40-12:00


    答疑  Q&A



    演讲嘉宾:

      Daniele Zuccato

      Daniele Zuccato achieved his Master Degree in Industrial Chemistry at Venice Cà

      Foscari University in the framework of a collaboration project with the National

      Research Council Institute on the speciation of heavy metals in foodstuffs with

      HPLC-ICP-MS hyphenated techniques.In 2009, he joined the R&D Glass Division of the Stevanato Group as project leader of the investigation studies on the migration of trace elements from the glass surface, following and coordinating from the very beginning the startup of the SGlab and assuming the position of Core Team Leader, in charge of the physicochemical improvement of pharmaceutical glass primary packaging.Dr Zuccato is member of ISO TC76/WG2 and secretary/ member of TC 12 “Glasses for Pharma” of the International Commission on Glass.



      Paolo Golfetto

      Paolo Golfetto is the chief technical relation Director of the Group Business area

      with the Industry’s stakeholders, associations, partners, coalitions. In his position

      he supports the critical evaluation of the market/customer needs from a technical

      point of view.Formerly the R&D Manager of the Appliances Engineering Team, Mr. Golfetto was in charge of the Product Design and Development, including the Technical support before his current position.Member of PDA, he is author of some papers for important magazines in the field. As Member of the European Electrotechnical Commission until 2005, Mr. Golfetto contributed in the development of European Norms and Regulations focused on users safety and environmental friendly consumer products.



      Gaetano Baccinelli

      Gaetano Baccinelli is the Sales Manager of Optrel, company of Stevanato Group’s 

      Engineering Division, specialized in manufacturing inspection machines for

      parenteral products.He spent seven years from 1992 to 1999 working in the USA

      branch of a well known Italian group worldwide leaders in those field as skilled    engineer into the after Sales Dept.He worked as manager of the After Sales and Service Dept. and as Area Sales Manager for leading companies in inspection systems following Japan and USA market.



      Andrea Salmaso
      Andrea holds a degree in Pharmacy at the Faculty of Pharmacy, Department of 

      Pharmaceutical Sciences, University of Padua.He is member of: Expert international

      commission ISO / TC76 / WG2-Rigid container systems and related accessories for

      Parenterals and injectables; Expert Committee UNI - Technical Commission U4201 Dispositivi non-active medical, transfusion, biological evaluation.After a long experience in Quality Assurance, he joined Ompi where he held the position of QA Manager in prefillable syringes plant.Now he is Corporate Regulatory Affairs Manager for the Whole Stevanato Group.





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