9:00 | Welcome address Joe Bhatia, President and CEO, American National Standards Institute (ANSI) Welcome address Rüdiger Marquardt, Member of the Executive Board, DIN |
9:15 | Keynote Speech Recent developments in electronic medical records – Implications for standardization and public policy Tim Büthe, Associate Professor of Political Science and Public Policy, Duke University |
9:45 | The Transatlantic Trade and Investment Partnership (TTIP) Moderator: Sibylle Gabler, Senior Manager Government Relations, DIN |
| TBT Chapter and Annex on Medical devices Isabel Pastor Arenillas, Trade Counselor, EU Delegation to the USA |
| U.S. perspective Ashley Miller, Director, Industrial Goods Market Access (TTIP sectors), USTR |
10:30 | Coffee Break |
10:45 | Standards in the EU and US – A tool for meeting global requirements Moderator: Gordon Gillerman, Director, Standards Coordination Office, NIST, US DoC |
| Harmonized Standards (EU) Matthias Marzinko, Director International Standards Management, Drägerwerk AG & Co. KGaA |
| Recognized Standards (US) Scott Colburn, Director, Standards, US FDA |
| Conformity Assessment – Keys to Multiple Market Access Dr. Royth von Hahn, Global Director Functional Safety and Software, Medical and Health Services, TUV SUD Product Service Division |
| What Global Companies are Doing Elisabeth George, Vice President of Global Government Affairs, Standards & Regulations, Philips Healthcare, USA |
| Brief Panel Discussion |
12:05 | Standards in Regulation - Use cases |
| Current issues - disposable medical products Herrmann Riesenberger, Head of Working Group Standardization, BVMed, The German Medical Technology Association |
| Electromedical devices Pamela Gwynn, Principal Engineer for Medical and Home Healthcare Equipment, Underwriters Laboratories (UL) |
| Standards and Medical Imaging Diane Wurzburger, Executive, Regulatory Affairs, GE Healthcare/MITA |
| Brief Panel Discussion |
12:50 | Lunch |
13:45 | Interoperability in the medical device sector Moderator: Hermann Behrens, Head of department Innovation, DIN |
| Internet of Medical Systems and IT Services Prof. Dr. J.-Uwe Meyer, CEO, CTO, MT2IT GmbH & Co. KG |
| Implementing Information Exchange Standards in Healthcare Facilities Dezso Csipo, President, Object Forge, Inc. |
| Interchange formats of medical documents – IT-specifications Dr. Georg Heidenreich, Manager Healthcare IT Standards, Siemens Healthcare GmbH |
| Safety and Security Standards for Medical Application Platforms John Hatcliff, University Distinguished Professor, Department of Computing and Information Science, Kansas State University |
| Medical Robots Mike Yramategui, Fellow Regulatory Engineer, Intuitive Surgical, USA |
15:25 | Coffee Break |
15:45 | Innovative future topics Moderator: Carol Herman, Senior Vice President, Standards & Policy Programs, AAMI |
| Safe and dynamic networking in operating room and hospital Björn Andersen, Research Assistant, University of Lübeck Institute of Medical Informatics |
| Risk management of 3D printed medical devices Roderick McMillan, Materials Development Manager, DePuy Synthes |
| Biocompatibility and evolution of risk management in safety evaluation of medical devices Jon Cammack, Global Vice President of R&D/Clinical Quality, AstraZeneca |
| Innovation and Adaptation in the Development of Standards for Absorbable Implants Byron Hayes, Biomaterials Research and Development, W.L. Gore & Associates, Inc. |
| Standardization in the field of regenerative medicine Prof. Dr. Michael Doser, Deputy director, Head of development in Biomedical Engineering, Institute of Textile Technology and Process Engineering |
17:05 | Panel Discussion on innovative future topics - Prof. Dr. J.-Uwe Meyer, CEO, CTO, MT2IT GmbH & Co. KG
- Dr. Georg Heidenreich, Manager Healthcare IT Standards, Siemens Healthcare GmbH
- Jon Cammack, Global Vice President of R&D/Clinical Quality, AstraZeneca
- Byron Hayes, Biomaterials Research and Development, W.L. Gore & Associates, Inc
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17:45 | Closing remarks |
| Rüdiger Marquardt and Joe Bhatia |
