 |
7th Annual
Drug Device Combination Products
（第7屆藥劑•機器組合產品學會） 2012年9月11-12日, Holiday Inn Munich City Centre, Germany
|
7th Annual Drug Device Combination Products
（第7屆藥劑•機器組合產品學會）
2012年9月11-12日 | Munich, Germany
有關組合產品的法規之重要資訊和產品開發的實用性建議
Informa LifeSciences主辦今年迎接第7屆的Drug Device Combination Products，是綜合性分析世界各國導入法規的要件、探尋今後發展方向的學會。此學會加上與法規有關的最新資訊，發表已成功獲得認可、與組合產品業界有關人員有益的見識，能確立有效的策略，畫出直到獲得認可之路，以及獲得確保競爭力的重要線索。
能獲得監督機關和認證機關(NB)的代表、業界的專家們重要的建議
-
針對歐洲、美國、拉丁美洲登記組合產品時蔚為問題的法規，能獲得重要的建議
繼續閱讀 -
能從因應業界實情的個案研究中找到強化藥劑•機器組合產品的安全性、減輕風險的實用性暗示
繼續閱讀 -
能獲得有關歐盟(EU)醫療機器指令(MDD)修改問題的最新重要資訊
繼續閱讀 -
能建構與組合產品有關之有效的合作關係，管理產品的變更，以及制定保護智慧財產權和專利之有效的事業策略
主要的2011年演講者
Expert Speaker Panel 2011
John Weiner
Associate Director for Policy, Office of Combination Products
FDA
|
Sabine Kloth
Senior Product Specialist
TUD SUD
|
Daniel Shoukier
Global Director Regulatory Affairs
Biosensors International
|
Mika Reinikainen
Managing Director
Abnovo Ltd.
|
- Janine Jamieson, Pharmaceutical Assessor, MHRA, UK
- Catherine McHugh, Executive Pharmaceutical Assessor,Irish Medicines Board, Ireland
- John Barlow Weiner, Associate Director FDA Office of Combination Products, FDA, USA
- Theresa Jeary, Certification Manager, BSi, UK
- Sabine Kloth, Senior Product Specialist, TÜV SÜD, Germany
- Martin de Bruin, Global Commercial Director, Medical, KEMA Quality/DEKRA Notified Body, The Netherlands
- Susana de Azevedo Wäsch, Head of Global Regulatory Affairs, Geistlich Pharma AG, Switzerland
- Sharon Fahy, Regulatory Affairs Manager,Medtronic, Ireland
- Ulla Christensen, Project Manager,Novo Nordisk AS, Denmark
- Anthony Wilkinson, Medical Director – Asia Pacific, Cook Medical, Australia
- Edward Reverdy, Director of Corp Toxicology, Boston Scientific, USA
- XinLin Zu, Senior Project Microbiologist,Zimmer GmbH, Switzerland
- Fabio Cirillo, Project Manager Biomaterials, Synthes GmbH, Switzerland
- Daniel Shoukier, Global Director Regulatory Affairs, Biosensors Europe, Switzerland
- Alejandro De La Garza, Managing Consultant/Regulatory Affairs, Actavis, USA
- Thierry Wagner, Regulatory Affairs Director EMEA, DuPont Medical & Pharmaceutical Protection, Luxembourg
- Gottfried Endel, Austrian Social Insurance Company, Austria
- Oriol Sola-Morales, Medical Director, Sabirmedical S.L., Spain
- Mika Reinikainen, Managing Director, Abnovo Ltd., UK
- Winifred Wu, President, Strategic Regulatory Partners, LLC, USA
- Noel Akers, European Patent & Trade Mark Attorney, N.J. Akers & Co., UK
Sponsors
舉辦日期和會場
2012年9月11－12日
Holiday Inn Munich City Centre
有關藥劑•機器組合產品的開發和分類的危機管理方法
藥劑•機器組合產品上市後的監測調查(PMS)
Post-Conference Workshop Y
2012年9月13日（星期四）
Post-market surveillance (PMS) for drug device combination products
Workshop Leaders:
Mika Reinikainen, Managing Director, Abnovo Ltd., UK
Susan Welzbacher, Head of Field Quality Assurance & Product Safety, Institut Straumann AG, Switzerland
藥劑•機器組合產品開發的管理：關於實務的個案研究、監督機關及認證機關方面的期待
Evening seminar X
2012年9月11日(星期二)
Managing drug device combination product development: Real life case studies and expectations from Competent Authorities and Notified Bodies
Pannelists include:
Janine Jamieson, Pharmaceutical Assessor, MHRA, UK
Catherine McHugh, Executive Pharmaceutical Assessor, Irish Medicines Board, Ireland
Martin de Bruin, Global Commercial Director, Medical, DEKRA, The Netherlands
Theresa Jeary, Certification Manager, BSi, UK
Sabine Kloth, Senior Product Specialist, TÜV SÜD Product Service GmbH, Germany
