- email:registrations@informa-ls.com
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6th Annual Drug Device Combination Products
Critical regulatory information and practical advice on development of combination products
Informa LifeSciences’ 6th 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 Asia-Pacific
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Discover practical advice on the registration and development of new combination products through industry case study examples
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Realise the importance of a well defined structure for post market surveillance and quality control
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Take home winning business strategies for establishing effective partnerships with combination products
Expert Speaker Panel 2011
Expert Speaker Panel 2011
John Weiner
Associate Director for Policy, Office of Combination Products
FDA
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Mark Campbell
Associate Director, Medical Technologies Evaluation Programme,
NICE
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Lindsay Tao
Corporate Director, Regulatory Government Affairs, Asia Pac & LATAM
J&J, China
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Jack Wong
Secretariat of AHWP and Co-chair of Training Committee
AHWP, Hong Kong
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- Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programmes, FDA, USA
- Thinh Nguyen, Director, Office for Combination Products, FDA, USA
- Janine Jamieson, Pharmaceutical Assessor, MHRA, UK
- Kerstin Stephan, Demarcation Expert, BfArM, Germany
- Martin de Bruin, Director Medical Businessline, KEMA Quality/DEKRAvNotified Body, The Netherlands
- Christian Schübel, Head IMC – Clinical Affairs, TÜV SÜD Product Service GmbH, Germany
- Theresa Jeary, Certification Manager, BSi, UK
- Mark Campbell, Associate Director, Medical Technologies Evaluation Programme, NICE, UK
- Lindsay Tao, Corporate Director, Regulatory Government Affairs, Johnson & Johnson, China
- Stefan Menzl, Director International Regulatory Affairs, Abbott Medical Optics, Germany
- Matthias Bürger, Vice President, Quality Assurance and Regulatory Affairs, EMEA, Zimmer, Switzerland
- John Kilmartin, Director of Regulatory Affairs, Medtronic, Ireland
- Asif Siddiqui, Director, Regulatory Affairs, Roche Molecular Systems, USA
- Anna Olejnik, Regulatory Affairs Manager, Boston Scientific, Poland
- Mika Reinikeinan, Managing Director, Abnovo Ltd, UK
- Sven Knoke, Quality and Regulatory Affairs Manager, Siemens AG, Germany
- Oliver Mast, Head Payer Marketing / Market Access, Roche Diagnostics, Germany
- Oliver Steinbach, Senior Director, Department Head Bio-Molecular Engineering, Philips Research Laboratories, The Netherlands
Media Partners
Dates and Venues
28 Sep 2011 - 29 Sep 2011
nhow Berlin
The essential event for all those working in Regulatory Affairs, Quality Assurance/Quality Control, Research and Development and Clinical Affairs with combination products
Identifying and overcoming the regulatory challenges relating to development and classification of DDCPs: A risk management approach
PRE-CONFERENCE WORKSHOP W: TUESDAY 27 SEPTEMBER 2011
Identifying and overcoming the regulatory challenges relating to development and classification of drug device combination products: A risk management approach
Workshop Leader: Paul Lafferty, Medical Technology Consulting, UK
Understanding marketing and advertising laws for drug-device combination products
POST-CONFERENCE WORKSHOP Y: Friday 30th SEPTEMBER 2011
Understanding marketing and advertising laws for drug-device combination products
Workshop Leaders:
Alexander Denoon, Lawford Davies Denoon, UK
Carolyn Heath, Renishaw plc, UK
Erik Vollebregt, Greenberg Taurig LLP, The Netherlands
Mathias Klumper, Lützeler Klümper Wachenhausen Rechtsanwälte, Germany
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Managing development of DDCPs:Vital feedback and case studies from CAs and NBs
EVENING SEMINAR X: Wednesday 28th September
Managing development of DDCPs:Vital feedback and case studies from CAs and NBs
Pannelists include:
Janine Jamieson, MHRA, UK
Martin de Bruin, KEMA Quality/DEKRA Notified Body, The Netherlands
Jill Hartzler Warner, FDA, USA
Kerstin Stephan, BfArM, Germany
Jack Wong,AHWP, Hong Kong
Theresa Jeary, BSi, UK
Christian Schübel, TÜV SÜD Product Service GmbH, Germany
