协会服务热线
010-6226-7180
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。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.