- email:registrations@informa-ls.com
- phone:+44(0)20 7017 7481
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7th Annual
Drug Device Combination Products
11 - 12 September 2012, Holiday Inn Munich City Centre
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7th Annual Drug Device Combination Products
Critical regulatory information and practical advice on development of combination products
Informa LifeSciences’ 7th Annual Drug Device Combination Products conference will deliver a comprehensive review of the global regulatory requirements, and future developments. Through a combination of regulatory updates and practical industry insights of successful combination product approval this conference is essential for establishing winning strategies for defining your combination product approval pathway to ensure a competitive edge.
Vital advice from Competent Authorities, Notified Bodies and Industry Experts
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Obtain essential regulatory advice on combination products registration in Europe, USA and Latin America
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Discover practical advice on enhancing safety and minimising risk associated with drug device combination products through real life industry case studies
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Crucial update on the recast of the EU Medical Device Directive (MDD)
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Take home winning business strategies for establishing effective partnerships with combination products, managing change control for combination products and protecting your product: IP and patenting
Expert Speaker Panel 2011
Expert Speaker Panel 2011
John Weiner
Associate Director for Policy, Office of Combination Products
FDA
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Sabine Kloth
Senior Product Specialist
TUD SUD
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Daniel Shoukier
Global Director Regulatory Affairs
Biosensors International
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Mika Reinikainen
Managing Director
Abnovo Ltd.
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- 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
- Alex Laan, Principal Certification Manager, DEKRA Certification B.V., 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
- 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
- Barry Sands, President and Founder, RQMIS Inc., USA
- 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
Spotlight Session Sponsor
Media Partners
Dates and Venues
11 Sep 2012 - 12 Sep 2012
Holiday Inn Munich City Centre
A risk management approach to development and classification of DDCPs
Post-market surveillance (PMS) for drug device combination products
POST-CONFERENCE WORKSHOP Y: Thursday 13 September 2012
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
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Managing drug device combination product development: Real life case studies and expectations from Competent Authorities and Notified Bodies
EVENING SEMINAR X: Tuesday 11 September 2012
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
Alex Laan, Principal Certification Manager, DEKRA Certification B.V., The Netherlands
Theresa Jeary, Certification Manager, BSi, UK
Sabine Kloth, Senior Product Specialist, TÜV SÜD Product Service GmbH, Germany
