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：

           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

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

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

茶歇  Tea break

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

演讲嘉宾：Gaetano Baccinelli

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

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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