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Double Seminar on Aseptic Filling and Containers


Mark your calendars for our next Complya Seminar Series featuring

特邀您预留时间参加本次智真生物系列特色研讨会

    “Containers and Delivery Systems for Biologicals

    “生物制剂包装容器和给药模式

    “Aseptic Filling for European and US Products

    “为欧美产品提供无菌灌装

Join us on Friday, July 28, at the Holiday Inn Pudong to hear international experts answer your questions on important issues for selection of container closure systems and production of aseptic products for international markets

欢迎参加728日星期五,在上海浦东假日酒店(上海市浦东新区东方路899号)举办的研讨会,会有国际专家讲解关于选择包装容器密封系统和为国际市场生产无菌产品的重要议题。

In the morning, listen to world-renown speakers from OMPI explain the technology behind glass vials and the information needed to determine the proper container and closure for your valuable drugs.  OMPI is a major supplier of glass tubing vials, cartridges, ampoules and syringes to the pharmaceutical industry worldwide.

上午的研讨会,由来自OMPI的著名专家讲解西林瓶背后的技术和为产品选择合适包装容器和密封件的重要信息。OMPI是为全球医药行业提供玻璃管制西林瓶、卡式瓶、安瓿瓶和注射器的主要供应商。

In the afternoon, learn from international scientists from Vetter as they describe the requirements for testing and release of products to be used in clinical trials or for sale in Europe and the US. Vetter is a leading contract development and manufacturing organization (CDMO) that specializes in the aseptic filling of syringes, cartridges and vials.

下午的研讨会,由来自Vetter的国际科学家讲述欧洲和美国用于临床或销售的产品的检测和放行要求。Vetter是专门从事注射器、卡式瓶、西林瓶无菌灌装生产的主要委托开发制造商。

Sign up now for these FREE outstanding presentations brought to you by Complya Asia.  A delicious buffet lunch is included for all participants.  This seminar will be bilingual in both Chinese and English.  Seating is limited.  Register at http://ompivetter.eventdove.com/ or send email to Juan (juan.shao@complya-asia.com).  Watch for additional details and tell your friends.

欢迎立即报名参加由智真生物筹备的免费研讨会。会议将为每位参会者提供午餐。本次研讨会演讲为英语和中文双语。名额有限。报名地址http://ompivetter.eventdove.com/或发送邮件给邵娟(juan.shao@complya-asia.com)。请耐心等候更多信息并转告您的朋友和同事。


Introductions of speakers and abstracts

 

Morning presentations include:

·         Introduction to the Stevanato Group

·         EZ-fill technology for vials

·         Pre-filled Syringes

·         Glass containers: chemistry and physics

·         Plastics for primary packaging

 

Morning Speakers and Presentations

 

Alessandro Orlando, Head of Sales Asia Pacific and Greater China

Alessandro holds a Bachelor’s Degree in Economics (EMBA)from Rutgers University in New Jersey, and he also holds a MS degree in Economics from the University of Pavia in Italy.

Alessandro has a relevant background and experience in the APAC Region, including Sales and Marketing Director in Food and Beverage Technology in SIPA Spa Hangzhou China, General Manager in Shanghai Sanqiang Engineering Technology Co, Shanghai, China, and Vice President International Markets in Yangzhou Xianye group, Yangzhou.

Stevanato Group is a worldwide producer of glass parenteral packaging for the pharmaceutical industry. From the outset, it has been self-sufficient in developing the necessary technology and machinery required to ensure the highest standards of quality and innovation throughout the production process. SG is specializes also in glass forming machines, inspection systems, assembly, packaging machines and serialization solutions for the pharmaceutical industry. With more than 65 years of experience Stevanato Group boasts a product and a process leadership, with 2 operative divisions (Pharmaceutical Systems and Engineering Systems) and 14 manufacturing sites throughout the world (Italy, Slovakia, Denmark, Mexico, China, US, Germany, Romania and Brazil). Stevanato Group’s mission is to create systems, processes and services that guarantee the integrity of parenteral drugs. Patients and final users are our focus and we aim to develop with our customers solutions that ensure their safety.

 

Sinan Dou,Pharma Sales Development Manager

Sinan holds a Bachelor of Physics and Electronics degree from Tianjin Nankai University and has important experience in Pharmaceutical devices.  He was the Technical Sales Manager in Getinge La-Calhene for sterilization transfer systems with responsibility forestablishing DPTE. He has published several professional articles on CNPPA Professional Journal.  Sinan was the account manager during his experience in Gerresheimer, responsible for Prefilled Syringes and in BD Medical as Account Manager & Sales Trainer for Greater China.His experience also includes responsibility forSales and Marketing Information as Sales Executive for TSKF(GSK), Shanghai.

Sinan will introduce Ompi EZ-fill, the Simple Way to fill vials and cartridges. The success of a manufacturing site is moving from site stability to site agility:in addition to maintaining stable production, pharmaceutical sites are now required to accommodate more changes and deliver on unexpected targets.EZ-fill Ready-to-fill packaging, reduces upstream operations for cleaning packaging, less operations steps: less risks of stops/failures. This technology allowsT.C.O Reduction, greater flexibility, and improved time-to-market.

 

Alessandro Morandotti is Product Manager Syringes

Alessandro Morandottiholds a Bachelor’s Degreein Electronic Engineering with a Master’s Degree in Biomedical Applications and Devices at the University of Padua. Alessandro has been working in OMPI since 2001 covering different positions: Production Manager, Process Development Manager, Special Projects Leader, Technical & Quality Assurance Front End Organization, and he is now Product Manager Syringes.                                           

OMPI PrefillableSolutions for Biologic Drugs.When we are speaking about biologics a clear trend is represented by the specificity of this type of pharmaceutical drug product, which is often very sensitive to one or more elements of the primary packaging, and includes highly viscous products where this specific element is continuously growing, and in parallel has aneed for increasing the overall dosage for making the delivery acceptable for the patient, with ever changing requirements for primary packaging and drug delivery devices. We will analyze Market and Industry trends and implications for drug delivery requirements and advanced SG solutions.


FlavioLorenzon, APAC Development Manager

Responsible for support and development of business in Asia Pacific and the Greater China Region, Flavio holds a Bachelor’s Degree in Aeronautical Engineering from the Polytechnic Institute in Italy and a Diploma for Business Management and Organization, MIP, from the Polytechnic Institute Milan, Italy.  WithStevanato Group since 2011, Flavio has initiated cooperation with SPAMI engineering division and has beenhadresponsibility for startup of Ompi of China Plant as Plant Manager of glass and Pharma Division in Zhangjiagang, Jiangsu Province.Flavio has relevant experience in China, includingOperations Director in DCS Steel Technology, Changshu. In Italyhe held the position of Operations Director, in Ansaldo-MangiarottiSpA Nuclear Technological Equipment Division.

Glass Containers for Pharmaceutical Use.Through the title of the Section 3.2.1 of the current edition of the European Pharmacopoeia, EP 8, we will understand the consequences when glass containers for pharmaceutical use are manufactured under stressed conditions (e.g. temperature time profile) or are placed in contact with particularly aggressive pharmaceutical preparations. In accordance with EP standards and definitions,a clear picture of delamination effects, and the mechanical (micro-cracks/fragility) issues of glass containers for pharmaceutics will be discussed.

 

Paolo Golfetto,Director of Business Development for Drug Delivery Systems and CDMO

In this role he leads the development and execution of the business strategy and plan in the fields of pen and auto injectors, large dose wearables, and respiratory drug delivery systems. In his position, while managing external technical communications, dissemination and promotion of the globalDrug Delivery Product platforms, services and solutions, he supports project acquisition and the transfer to internal development structures of the Group.Before taking this position, Paolo was in charge of Product Design and Development, including technical support to the Group’s biopharmaceutical clients, coordinating experts in glass technology, process engineers and designers.  A member of PDA, Mr.Golfetto provides presentations and lectures widely in healthcare industry organizations and associations.  He is the author of severalpapers for important journalsin the field.

Balda Pharmaceutical Systems.Balda is a “One Stop Shop" CDMO based upon precision Injection Molding Technology. Balda develops and delivers customized solutions for the pharma, diagnostic and medical technology industries, providing life cycle services from idea generation, product design, development, industrialization, regulatory approvals, full scale production and logistics solutions. The core technologies are multi-component precision plastic injection molding (clean room), automated system assembly, and surface decoration as well as tool making.


Qing Li, APAC Marketing Manager

Qing holds a Bachelor’s ofPhysics and Electronics Degree from Tianjin Nankai University.

He has strong work experience in the pharmaceutical industry for over15 years.  Before joining SG, Qing was the Sales Manager for China and Taiwan forGerresheimerBünde GmbH, where he was responsible for Prefill product marketing in North East Asia and Customer quality management, and he was manager of CQA/TS, BDPS China in Becton Dickinson Medical Devices (Shanghai) Co., Ltd., in charge of customer education of PS product and its applications.


Afternoon Speakers and Presentations

 

Chervee Ho, Director Key Account Management AsiaPacific, Vetter Pharma International GmbH

Chervee Ho holds a Bachelor’s Degree (HONS) in Biotechnology from the University Putra, Malaysia and has worked in the pharmaceutical and in-vitro diagnostic industry since 1994. Her previous companies include Roche Malaysia and Lonza Singapore where she held sales and marketing positions including product management and business development. Her primary responsibilities focused on developing new markets in Asia and Australia, supporting customers from conceptualization to commercialization of new product lines, and managing customer relationships. Currently, Chervee is the Director of Key Account Management for Asia Pacific at Vetter, and leads the established regional office based in Singapore.

A unique blend of experience – Vetter services help companies achieve success

With over 35 years of experience in contract manufacturing, Vetter is a worldwide specialist in the aseptic production of prefilled injection systems with a specialization and expertise in all phases of product life phases. Vetter offers quality leadership, innovation, cutting edge processes and technology, and security of supply. With a partnership approach to drug development the company can optimize every stage of product growth. Its independent production sites across the globe offer flexibility and security in production and packaging and help navigate projects from clinical development to market supply, selecting the best packaging option for a compound.

Attendees will gain an awareness of:

·         Company history and key statistics

·         Areas of specialization and depth of experience in substance classes

·         Production site locations and capabilities

·         Experience in drug development/delivery packaging technology and innovation


Oskar Gold, Senior Vice President Key Account Management /Marketing/Corporate Communications, Vetter Pharma International GmbH

Oskar Gold is Senior Vice President of Key Account Management and Marketing/ Corporate Communications at Vetter and in charge of the company’s global business development. Before joining Vetter, he managed the European business development of a pharmaceutical component manufacturing company, serving in various functions, including vice president and managing director of group companies. Mr. Gold studied at schools in the United Kingdom, France and in Germany. He completed graduate studies in international business administration at INSEAD, Fontainebleau. Mr. Gold has also taught and lectured on international business strategy and marketing at a European university.

Getting the most from your drug development program – plan early to achieve success

Selecting the right CDMO from the very start can help make the difference

With costs associated with early drug development ever-increasing, any combination of negative events can cause irrevocable harm to a small biotech or pharmaceutical company, particularly one with limited cash reserves. These events are many and range from limited experience among employees resulting in a reliance on outside expertise, limited access to capital, a lack of proper facilities, or the inability to generate enough API for the development phase.Getting help from the very start in the form of an experienced outsourcing partner can oftenbe the best solution. Theright partner in the form of a contract development manufacturing organization (CDMO) can help navigate your project from drug discoverythrough pre-clinical development and ultimately,help you select the best packaging option for your compound. But how do choose the right outsourcing partner, and what particular areas of expertise and level of resources should they possess? What options exist for drug developmentand packaging, and what are their individual benefits?

This presentation will provide insight into these questions and offer guidance into the evaluation process associated with selecting the right CDMO, helping to ensure the right fit and resulting in a development program that meets your drug’s needs.How to conduct a search for a right CDMO,the attributes to consider including the creation of a realistic plan, major milestones to be achieved, necessary resources and more will be discussed. Also included will be an in-depth discussion of the differing drug delivery systems available on the market today, including prefilled syringes.

Attendees will gain an awareness of:

·         Key attributes to consider in the search for the right CDMO

·         How to create a successful partnership from the very start

·         Current market trends in drug development/delivery packaging options


Dr. Baerbel Hinneburg

Director Technology & Process Transfer, Vetter Pharma-Fertigung GmbH &Co. KG

Bärbel Hinneburg received her Ph.D. in chemistry from the Miami University in Ohio in 1999. After joining the Development Service Department at Vetter Pharma-Fertigung in 2001 she has been focused on the development of pharmaceutical processes for pre-filled liquid and freeze-dried systems and the technical transfer of new products in aseptic production. After 12 years of leading the group Process Implementation, she became Director Technology & Process Transfer in 2016. 

Developing in a prefilled syringe? Add unique value to your compound

Injection systems add value at clinical and commercial stages. This presentation will examine the advantages of prefilled syringes, including the various differentiators and most commonly used syringe platforms, both pre-sterilized and bulk. Factors to be considered in making the right choice of prefilled syringe formats will be revealed. Customization in syringe packaging materials and production steps, along with techniques for coping with more challenging compounds, e.g., sensitivity to silicone or reduced particle load, will be reviewed. Innovations in prefilled syringes that help meet today’s market challenges will be highlighted. The participant will:

·          Gain an understanding about the two prefilled syringe platform technologies on the market: pre-sterilized syringes and bulk syringes

·          Learn how prefilled syringes can offer distinct advantages in product differentiation and life cycle management strategies.

Learn how to choose the syringe system for your compound and how prefilled injection devices, which have been designed with safety and simplicity in mind, might best be incorporated into a drug development program.



活动主办方:

苏州智真生物技术咨询有限公司

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时间

2017-07-28 09:00 - 开始

2017-07-28 16:00 - 结束

已结束
地点
  • 中国 上海 浦东新区
  • 上海浦东假日酒店