时间/地点：2018年9月1日（Sept 1）/多功能1（F1）

主办单位：                                                                                                        

合作单位：

日程安排：

8:30 - 8:45

开幕辞  Opening

戴彦炯，杜邦公司亚太区市场经理
Diana Dai, DuPont  Asia Pacific Marketing Manager

药械组合产品包装的关注点

Packaging considerations for combination products

药械组合产品注册的法规要求

Regulatory Requirements for Drug-Device Combination Product  Registration

王旭辉,劳氏质量认证北亚区医疗器械技术经理     

Xuhui Wang,Medical Device Technical Manager, North Asia,Lloyd's Register Quality Assurance   

茶歇  Break

端对端无菌保证                        

End to End Sterility Assurance

Matt Roybal 美国强生公司全球大外科业务无菌保证高级总监                                     

Matt Roybal，Senior Director, Sterility Assurance, Global Surgery, Johnson & Johnson

答疑  Q&A

午餐  Lunch

最新灭菌技术应用与发展             

New sterilization technology & development

Bill Young,施洁公司 灭菌科学与技术资深副总裁                               

Bill Young,Senior vice president of sterilization science & technology,Sterigenics

汽化过氧化氢灭菌在预灌装给药系统及医疗器械灭菌的应用介绍                     

Sterilization of Pre-Filled Drug Delivery Devices and Medical Devices using Vaporized Hydrogen Peroxide (VHP)  

Matt Hofacre，STERIS全球应用项目管理总监                              

Matt Hofacre，Director of Global Application Project Management and Services Segment, Life Sciences，STERIS

茶歇  Break

杜邦™特卫强®包装为医药无菌加工提供保护                                

DuPont™ Tyvek® -  Packaging Protection For Aseptic Processing

Eric Schmohl，杜邦公司 全球医药包装市场总监                                

Eric Schmohl，Global Pharmaceutical Market Leader for DuPont Medical & Pharmaceutical Protect

含药医疗器械包装的材料选择与评价       

Packaging material selection and evaluation for combination products

李然，上海微创医疗器械（集团）有限公司 高级工程师

Ran Li, Senior Engineer, Shanghai MicroPort Medical (Group) Co., Ltd.
                                                                        

交流  Q&A

演讲嘉宾：

  Michael H. Scholla

 是美国医疗器械促进协会(AAMI)董事会前任主席，灭菌标准化委员会共同主席，同时也

 是标准制定战略委员会的成员。Michael H. Scholla博士是ISO TC198 WG7医疗包装标

 准工作组的召集人，负责协调EN ISO 11607标准在全球的统一发展，他也是《美国医疗医药包装杂志》编委，和美国微生物学会30年会龄的会员。Michael H. Scholla博士目前就职于杜邦公司，任杜邦全球标准与法规总监。

  王旭辉

  曾在美国DIG负责医疗器械质量设计技术管理，CFP理论的创立者，拥有十余年临床医学实

  践经验，并先后在英国、德国、荷兰等公告机构和认证机构担任医疗器械技术经理、高级讲

  师、CE和ISO13485主任审核员等职十余年，是医疗器械临床及统计应用专家，微生物灭菌专家，拥有丰富的实战经验，曾主导欧盟和美国产品上市项目超过50余项。

  Bill Young

  早年毕业于伊利诺斯大学，取得生物学学士学位，同时还研修了物理、化学两个学科，之后

  又在湖森林商学院攻读了工商管理硕士学位。四十多年来，他从事微生物研究，消毒过程设

  计，控制，技术开发和质量保证等方面工作，积累了极其丰富的经验。 Bill曾担任过多个领导职务，如服务中心总管，咨询服务总监，环氧乙烷消毒技术副总裁，以及整个施洁公司的实验室测试和咨询服务副总裁。  近20年，他代表施洁活跃在多个国际医疗器械专业协会，参加过很多国际消毒灭菌标准的制定，是著名的消毒灭菌领域专家。

  Matt Hofacre

  Matt Hofacre is Director of Global Applications and Project Management for STERIS

  Corporation Life Sciences Division, a leading provider of infection prevention and

  contamination control products and services.  Mr.Hofacre has been with STERIS Corporation since 1999 with experience in the life science pharmaceutical/biopharmaceutical production, food and beverage, high containment, and laboratory research industries. He and his team are responsible for design applications, project maintenance, and technical guidance for VHP, Steam Sterilization, Washing, and Water Systems. Mr. Hofacre has a B.Sc. in Chemical Engineering from the University of Cincinnati and a MBA from Cleveland State University. He is a presenter and trainer at national and international conferences including The Parental Drug Association (PDA), International Society of Pharmaceutical Engineers (ISPE), American Society of Mechanical Engineers (ASME), Tradeline, Asia Pacific Biological Association (A-PBA), and Medical Device Asia. Mr. Hofacre served as co-Author for PDA Technical Report 48 : Moist Heat Sterilization Systems, J&J 3rd Annual Sterility Assurance Conference, and has contributed to numerous other articles on WFI systems, VHP, and Pharmaceutical Equipment Selection.

  Eric Schmohl

  Eric Schmohl is the Global Pharmaceutical Market Leader for DuPont Tyvek(R)

  Medical & Pharmaceutical Protection. He is a graduated Textile Technology

  Engineer and has more than 20 years of experience of Technical Support, Sales and Marketing within former DuPont Fibers division and since 2001 in the Nonwovens division. Early 2017 he took over the EMEA Market Manager Role while starting in his current assignment. Since April 2018 he is fully dedicated to the Pharma Market.

  李然

  就职于上海微创医疗器械（集团）有限公司（总部）品质部，担任高级工程师，拥有7年以

 上医疗器械包装及标识设计经验，5年以上医疗器械包装设计验证经验，熟练掌握

 SFDA\FDA\CE对医疗器械包装及标识的法规&标准要求，参与并主导多个含药医疗器械产品的包装开发及包装验证工作，部分产品已经获准上市销售。

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