3-5 März 2009Konferenz
Below is the 2009 MEDTEC Europe Conference programme. All sessions will be presented in English.
Tuesday, 3 March 2009
| 08.45 Registration and Coffee 09.00 Chair's Opening Address 09.15 Keynote Address: Strengthening the EU Regulatory Framework for Medical Devices Peter Bischoff-Everding, Medical Devices and Cosmetics Division, Directorate-General for Enterprises and Industry, European Commission |
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| Session 100 — Regulation | Session 101 — Effective Medical Device and Diagnostic Development  |
| 10.30 Chair Mika Reinikainen, Managing Director, Abnovo |
10.30 Chair John H. (Jack) Linehan, PhD, Stanford University and Jan Pietzsch, Wingtech, Inc. Introduction Martyn W.C. Howgill, Executive Director, InHealth Device and Diagnostic Development: A Road Map Jan Pietzsch, Wingtech, Inc. |
| 10.45 The Future of Medical Regulations in Europe Mika Reinikainen, Managing Director, Abnovo |
10.45 Phase I: Needs Assessment and Risk Analysis Bernd Schöller, VP Innovation Management, Weinmann Geräte für Medizin GmbH + Co. KG |
| 11.30 Eucomed’s Response to the Recast John Brennan, Director Regulatory Affairs, Eucomed |
11.30 Phase II: Formulation/Concept and Feasibility Dr. Dieter Engel, Technical Director, Maquet GmbH & Co. KG Invited |
| 12.15 How Will the Amendments to the MDD Affect your Notified Body Audit? Françoise Schlemmer, Manager of Quasys & Director of TEAM-NB - The European Association Medical devices – Notified Bodies |
12.15 Phase III: Design and Development/Verification and Validation Dr. Konstantin von Martius, Principal Consultant, Quintiles |
| 13.00 Lunch | 13.00 Lunch |
| 14.15 A Competent Authority Viewpoint Matthias Neumann, Bundesministerium für Gesundheit Referat 116 "Medizinprodukte" Federal Ministry of Health, Germany |
14.15 Phase IV: Final Validation/Product Launch Preparation Dr. Gabriela Soskuty, VP Government Affairs, Health Policy & Economics, B. Braun Melsungen AG |
| 15.00 Break | 15.00 Break |
| 15.15 Round Table Q&A | 15.15 Phase V: Product Launch and Post Launch Assessment Dr. Ing. Hans-Jürgen Wildau, VP Health Services, Biotronik GmbH & Co. KG |
| 16.00 End | 16.00 Discussion |
| 16.15 End | |
Wednesday, 4 March 2009
| 08.45 Registration and Coffee 09.00 Chair's Opening Address Paul Lafferty, Principal Consultant, Quintiles 09.15 Keynote Address: Integration of European Regulations into the Design Process for Medical Devices Jean-Marc Abbing, Senior Consultant, DHV B.V., Environment & Safety – Industry. Currently with Medtronic |
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| Session 200 — International Compliance and Sustainable Development | Session 201 —Testing Medical Devices for Increased Reliability throughout the Product Life Cycle |
| 10.30 Chair Paul Lafferty, Principal Consultant, Quintiles |
10.30 Chair Dr. Dieter R. Dannhorn CEO and President, mdt Medical Device Testing GmbH |
| 10.45 Risk Management: A Process for Sustainability Paul Lafferty, Principal Consultant, Quintiles |
10.45 Requirements for Good Testing Practices in the field of Medical Devices (MDD, IVDD, EN ISO/IEC 17025, GLP) Dr. Undine Soltau, Director, ZLG |
| 11.30 The Philips Healthcare Way to Greener Products Stefan Kreider, EcoDesign Representative and Hans van der Wel, Senior Manager Ecodesign and Sustainability, Philips Healthcare |
11.30 Shelf Life Studies of Medical Devices and Medical Device Packages Dr. Dieter R. Dannhorn CEO and President, mdt Medical Device Testing GmbH |
| 12.15 EuP: The COCIR Self Regulatory Approach Dr. Freimut Schröder, Vice President Environment, Health & Safety and Product Testing Laboratory for Siemens Healthcare |
12.15 Preclinical Testing for the Medical Device Industry: Testing of Material Properties, Leachables and Surface Cleanliness Jonas Weissenrieder, PhD, Group Leader - Principal Scientist, Pace Analytical Life Sciences |
| 13.00 Lunch | 13.00 Lunch |
| 14.15 Drug-device Combinations and Converging Solutions. GHTF and ICH;Two Worlds United? Dr. Jos Kraus, Senior Inspector, Dutch Inspectorate of Health Care, The Netherlands, and Member of the GHTF Steering Committee |
14.15 Clinical Investigation of Medical Devices for CE-Marking: Practical and Regulatory Guidance Dr. Dieter R. Dannhorn CEO and President, mdt Medical Device Testing GmbH |
| 15.00 Break | 15.00 Break |
| 15.15 EU Law on Advertising and Marketing of Medical Devices Linda R. Horton, Partner, Hogan & Hartson LLP |
15.15 Reprocessing of Medical Devices: Validation of Cleaning, Disinfection and Sterilization According to EN ISO 17664 and How to Implement the Results in the Instructions for Use Clemens v. Brühl, Product Manager Accessories, Heraeus Medical GmbH |
| 16.00 End | 16.00 End |
Thursday, 5 March 2009
| 08.45 Registration and Coffee | |
| Session 300 —Legal and Regulatory Issues From An Industry Perspective | Session 301 —Total Project Planning and Management |
| 09.10 Chair Introduction: Actual Legal Developments Rainer Hill, Deputy Director General, BVMed |
09.10 Chair Peter Lawes, PhD, CEng, F.I.Mech.E, MIET, MTech. BSc. Dip Mgmt., Medical Devices Consultancy .....from concept to market..... |
| 09.15 MDD Recast; New Approach Review and Protection of the CE marking Rainer Hill, Deputy Director General, BVMed |
09.15 Total Project Planning and Management Peter Lawes, PhD, CEng, F.I.Mech.E, MIET, MTech. BSc. Dip Mgmt., Medical Devices Consultancy .....from concept to market..... |
| 10.00 Market Surveillance in Germany from a Federal Authority’s Perspective Dr. Dirk Wetzel, Head of the Medical Devices Division, German Federal Institute for Drugs and Medical Devices (BfArM) |
10.00 Materials Selection in Medical Device Industry: The challenges of Balancing Engineering and Regulatory Risks in Device Development Anna Norlin-Weissenrieder, Ph. D., Principal Scientist, R&D Science and Technology Cardiovascular Division, St. Jude Medical, Inc. |
| 10.45 Break | 10.45 Break |
| 11.00 Directive 2007/47/EC - Particular Aspects: E-Labelling and Clinical Evaluation Dr. Joachim Wilke, Director Regulatory/Quality & Compliance Austria/Germany/Switzerland, Medtronic |
11.00 A Systematic Approach to Biocompatibility Ken Brummitt, Principal Research Engineer, DePuy international a Johnson and Johnson company |
| 11.45 Directive 2007/47/EU and RECAST - Regulatory Consequences for the Medical Device Industry Dr. Jos Kraus, Senior Inspector, Dutch Inspectorate of Health Care, The Netherlands, and Member of the GHTF Steering Committee |
11.45 Material Related Failure Modes in the Device Industry; Why Material Knowledge Gaps Can Introduce Fundamental Design Flaws into your Device Anna Norlin-Weissenrieder, PhD., Principal Scientist, R&D Science and Technology Cardiovascular Division, St. Jude Medical, Inc. |
| 12.30 Lunch | 12.30 Lunch |
| 14.15 New MEDDEV-System, Post Market Surveillance and Practical Issues Dr. Wilhelm Emmerich, Regulatory & Public-Affairs Mgr. G/S/A, BD |
14.15 Validation: A Thought for the Closet? Or Is It Make or Break David Sanders, CEO of Always The Best Lda Quality Management Consultancy, Medical Devices and Health Care Organizations |
| 15.00 Break | 15.00 Break |
| 15.15
New Vigilance MEDDEV and Practical Issues Hauke Schik, Quality & Regulatory Affairs Manager, Philips Medizin Systeme Boeblingen |
15.15
Information Systems to Support Medical Device Design Sarah Egan, Product Manager and Senior Information Author, Granta Design |
| 16.00 End | 16.00 End |