Labelling Compliance for Medical Devices and IVDs 2012
適合醫療機器及體外診斷機器的標籤表示法
2012年10月23-24日
UK, London, Grand Connaught Rooms

第6屆年度會議Labelling Compliance for Medical Devices & IVDs

有關UDI、e-標籤、添加文件和適合法規的重要最新動向

這次Informa Life Sciences的Labelling Compliance for Medical Devices and IVDs會議迎接第6屆。

務必要參加有管轄當局及指定機關的代表出席、提供重要法規的最新動向、同時針對業界上層主管與費用對效果高的適合標籤表示及添加文件敘述策略性的見解之活動。主要的主題是e-標籤、UDI（機器固有的識別）、記號、翻譯軟體、內容管理及醫療機器指令的標籤表示要求事項之修訂內容等。

是歐洲唯一聚焦於適合醫療機器及體外診斷機器標籤表示法的活動。

適合標籤表示法的專家委員會

Görkey Turgut, Biomedical Engineer, Department of Medical Devices, Pharmaceuticals and Medical Devices Agency, Republic of Turkey Ministry of Health, Turkey
Paul Jenkins, Scheme Manager/Product Specialist, Orthopaedic & Dental Healthcare, BSI, UK
Gil Lee, Program Manager – Stryker Operations Excellence, USA
Martin Luetzelschwab, Head of Labelling & Packaging, Roche Diagnostics GmbH, Germany
Laurie Jordan, Manager, Packaging Development, Advanced Surgical Devices, Global Operations, Smith & Nephew, USA
Scott Mathis, Vice President, Siemens Healthcare Diagnostics, USA
Kurt Frech, Head of Technical Publication Global, KaVo, Germany
Anja Kontio, Registration Manager, Orion Diagnostica Corp, Finland
Elvia Padilla, NLA Compliance and Regulatory Affairs, Director, BD, Mexico
Richard J Saunders, Senior International Regulatory Affairs Manager, Ortho Clinical Diagnostics - A Johnson & Johnson Company, UK
Rob Bergman, Project Manager, Package Labelling, W. L. Gore & Associates Inc, USA
Joachim Wilke, Director Regulatory Affairs & Policy Europe, Medtronic (tbc)
Ton van Zijl, Chair, EHBICC
Nicole Denjoy, COCIR Secretary General and DITTA Vice Chair
Sebastian Göttel, Director Sales, SCHEMA GmbH, Germany
Alison Brown, Partner, Arnold & Porter LLP, UK
Elisabethann Wright, Partner, Hogan Lovells, Belgium
Laurie Clarke, Partner, King & Spalding LLP, USA
Barry Sands, President and Founder, RQMIS Inc, USA
Céline Malo, International Regulatory Affairs Consultant, meditec Consulting GmbH, Switzerland
Mika Reinikainen, Managing Director, Abnovo Ltd, UK
Howard Dobbs, Principal Consultant, HSD Consulting, UK
Ben Jacoby, Principle Consultant, Cambridge RA Ltd, UK

Sponsor

Exhibitors

Media Partners

教育訓練與開發

CPD Certification Service是支援所有的專業機關、團體、協會、網羅全部市場部門、營運的獨立團體。本團體認定的CPD“品質標誌”已被認知作為品質保證教育訓練的象徵。CPD Certification Service的主要任務乃認定會議中提供的訓練課程和論文、其他具教育性的有益資料內容適合全球認可的CPD方針。

請勿錯過這些主要會議。

10月22日(星期一)
Pre-conference Workshop X
實踐因應有關標籤表示之全球性要求事項
各國的狀況－美國、亞洲太平洋、拉丁美洲

10月25日（星期四）
Post-conference Workshop Z
有關標籤設計的實踐性解決方案：使用實際的產品事例
請實踐活用在會議上學會的方法

10月23日(星期二)
晚上研習會S
法規討論會：修訂醫療機器指令的影響
包含建構人際關係的晚餐

發表的新演講者

Bianca Maria Gravenhorst Greve, Regulatory Affairs Manager, Coloplast A/S, Denmark will be speaking on: Successfully meeting regulatory requirements for the IFU (Instructions for Use)

MDD requirements for the IFU
Practical solutions for satisfying the regulatory requirements
CMC decision no. 4 “Improvement of Readability of Instructions for Use”

Francesco Laterza, RAQA Manager, Stryker, Italy will be presenting:
Critical overview of the new promotional material regulation in France and evaluating the impact on labelling in Europe