UDI/GMDN Forum. 08:30-12:00, August 28

Transcription

1 UDI/GMDN Forum 08:30-12:00, August 28 Co-Chair: Yang Lianchun Director of Registration DivisionⅡof the Department of Medical Device Supervision, CFDA, Chairman of the UDI/GMDN Special Task Group of AHWP, Maste. He was once appointed as pharmacist, pharmacist-in-charge, associate chief pharmacist in Air Force General Hospital, PLA, associate chief pharmacist, Chief pharmacist in Center for Certification of Drug, CFDA. Co-Chair: Dennis Hahn Director of Regulatory Environment Asia-Pacific & Latin America for Johnson & Johnson Global Surgery Group. He has worked in the medical device industry for 30 years, the past 20 in Regulatory Affairs. He has held positions of increasing responsibility in Research & Development, Engineering and Regulatory Affairs. He has broad experience with in the registration of medical devices globally, with numerous 510(k) and PMA approvals to his credit, as well as significant approvals in Japan, Taiwan, China, Korea, Thailand, European Union and other markets. He received his Bachelor of Engineering degree in chemical engineering from the Stevens Institute of Technology. 08:30-08:35 Introduction of the Co-Chairs 08:35-09:15 Introduction on Progresses of Naming and Numbering of Medical Devices in China Yang Lianchun, Director of Registration Division Ⅱ of the Department of Medical Device Supervision, CFDA, Chairman of the UDI/GMDN Special Task Group of AHWP, Master. He was once appointed as pharmacist, pharmacist-in-charge, associate chief pharmacist in Air Force General Hospital, PLA, associate chief pharmacist, Chief pharmacist in Center for Certification of Drug, CFDA. 09:15-09:45 UDI Now and How Ulrike Kreysa, Vice-President Healthcare, GS1 Global Office, Brussels. She is responsible for the Healthcare sector at the GS1 Global Office in Brussels and works with her local colleagues in 111 countries across the world to develop and implement GS1 standards in the healthcare industry. Having started her career as a Pharmacist she manages GS1 Healthcare, the global GS1 user group, formed by the stakeholders in the healthcare supply chain, including pharmaceutical and medical device manufacturer, wholesaler/distributor, group purchasing organizations, hospitals, pharmacies, logistic providers, governmental and regulatory bodies and associations. She works with decision makers from stakeholders and regulatory bodies to drive harmonization of standards in the implementation across the world to achieve supply chain efficiencies and increase patient safety. She is a regular speaker at conferences worldwide. 15

2 09:45-10:15 UDI Current Situation in Japan Hiroshi Ishikawa, Technical Expert, Division of Office of Review Management Pharmaceutical Affairs Consultation Group on R&D Strategy, Pharmaceuticals and Medical Devices Agency (PMDA), Japan. He is responsible to support consultation activities to promote and activate the innovative medical devices in Japan, especially for academia and venture business. About the international work, he is the member of the UDI working Group of IMDRF as a representative of PMDA. 10:15-10:30 Tea Break 10:30-11:00 GMDN A Requirement for UDI Barry Daniels, Technical Lead at GMDN Agency with responsibility for management of the GMDN dataset and overseeing the Agency's IT infrastructure. He started his career as a medical doctor, training in a number of surgical specialties before moving into medical IT as a systems analyst with particular interest in the implementation of medical coding systems. Then, after a period working as software developer specializing in website and database development, he joined the GMDN Agency. 11:00-11:30 UDI Drives Information Management Improvement Alex Jiang, Senior Quality Assurance Manager of Smith & Nephew China. He is responsible for Quality Management System, post-market surveillance (product complaint and recall implementation), product quality management, product registration process management, etc., and also responsible for the projects of Emerging Markets and International Markets, and participates in the global processes/ systems development representing this region. He has distinctive understanding of global Unique Device Identification (UDI) system under the global regulatory framework for medical devices, with his particular expertise of computer pattern recognition. He actively participates in promoting and developing the regulations and standards for the identification of medical devices. He has the systematic experience for labeling conversion, product registration information management and inventory management software systems. To meet the requirements of global UDI regulations, he built the integrated system, associating the standard process for product registration and the requirements of UDI, to control all kinds of labeling conversions, which has been certified underiso13485 quality management system certification. 11:30-12:00 Unique Device Identification Dennis Hahn, Director of Regulatory Environment Asia-Pacific & Latin America for Johnson & Johnson Global Surgery Group. He has worked in the medical device industry for 30 years, the past 20 in Regulatory Affairs. He has held positions of increasing responsibility in Research & Development, Engineering and Regulatory Affairs. He has broad experience with in the registration of medical devices globally, with numerous 510(k) and PMA approvals to his credit, as well as significant approvals in Japan, Taiwan, China, Korea, Thailand, European Union and other markets. He received his Bachelor of Engineering degree in chemical engineering from the Stevens Institute of Technology. 16

3 13:30-18:00, August 28 Co-Chair: Li Jingli Director of Medical Device Standards Management Center, CFDA (National Testing Institute of Food and Drug Control; Medical Device Standards Management Center), Chief Pharmacist, instructing and organizing 23 standardization technical committees of China for medical device standardization system construction, medical device standard formulation and modification, key standards research, nomenclature and classification coding technique research. She has been the deputy chief for spotcheck management office of SFDA Post-market supervision, responsible for medical device spotcheck management. Co-Chair: Jackie Rae Elkin Global Process Owner of Standard Product Identification for Medtronic, Inc. Global Regulatory Affairs. She has been working in the medical device sector for more than 27 years and recognized in the healthcare sector as a leader. She has co-chaired the AdvaMed Auto-Identification Committee since She is one of the founding members of GS1 Global Healthcare and has also been involved in many of the GS1 Global Healthcare work teams. She also chairs the GS1 Global Healthcare Public Policy work group for the medical device sector. In this role, she has engaged with regulators around the world to provide guidance on implementation of global healthcare standards and advocates for movement towards harmonized standards in the global healthcare supply chain. 13:30-13:35 Introduction of the Co-Chairs 13:35-14:20 Unique Device Identification - Situation in the International Medical Device Regulators Forum (IMDRF) and in the European Union Laurent SELLES, International Relations for the Health Technology and Cosmetics Unit of the Directorate General Health and Consumers of the European Commission, graduated from the 'Physics and Chemistry School of Paris' (including research at Northeastern University, Boston, USA) and from the University of Paris VII with an Advanced Studies Degree in 'Physics of Energy'. After 12 years in the automotive industry in R&D activities, he joined the European Commission to launch the Polis/Telecities network of European cities. He was in the Cosmetics and Medical Devices unit as a deputy head of unit, for all policy and international issues regarding public safety. The international cooperation consists of bilateral dialogues between the EU and its main trading partners and of multilateral frameworks (such as the Global Harmonization Task Force for Medical Devices GHTF, the International Medical Device Regulators' Forum IMDRF and the International Cooperation on Cosmetics' Regulation ICCR).He also chairs the GHTF/IMDRF working group on Unique Device Identification (UDI) with the aim of permitting traceability on an international level. 14:20-15:00 Latest Progresses of Technology Studies on Medical Device Nomenclature Li Jingli, Director of Medical Device Standards Management Center, CFDA (National Testing Institute of Food and Drug Control; Medical Device Standards Management Center), Chief Pharmacist, instructing and organizing 23 standardization technical committees of China for medical device standardization system construction, medical device standard formulation and modification, key standards research, nomenclature and classification coding technique research. She has been the deputy chief for spot-check management office of SFDA Post-market supervision, responsible for medical device spot-check management. 17

4 15:00-15:40 New UDI Guidance from Europe Gert W. Bos, Head of Regulatory and Clinical Affairs at BSI Healthcare (NB0086 / NB0535) and Head of Notified Body at BSI-Germany (NB0535).He earned his PhD at Twente University of Technology, Enschede, the Netherlands. He has 21 years of experience in life sciences (devices and pharma), in university, industry as well as in four Notified Bodies. He is president of the Notified Body association TEAM-NB, vice-chair of the Medical Notified Body forum NB-Med in Brussels, and participates in the Notified Body Recommendation group (NBRG), the Clinical Investigation and Evaluation Group (CIE), Medical Device Expert Group (MDEG) and the MDEG workgroups on animal tissue, on MRA's, e-labeling, EUDAMED and on IVD's. He is one of the Regulators representing Europe in the IMDRF Workgroup on regulated Product Submissions. He is a member of the board of the Dutch RA Chapter. 15:40-15:55 Tea Break 15:55-16:00 Introduction of GS1 China Li Jianhui, Director of the Application & Promotion Department GS1 China, General Engineer, Secretary-General of Chinese ECR Committee. She is mainly responsible for application and promotion of article numbering, product bar code, electronic product code and auto-identification technology in fields such as food safety, product tracing & recalling, logistics, electronic business, medical care, mobile commerce and Internet of Things, and has years of experience in research, technology application and management of article numbering & auto-identification technology, standardization, supply chain management, electronic business and other fields. 16:00-16:40 Application and Forecast of Uniform Numbering of Medical Devices in the Age of Big Data Huang Zexia, Deputy Director of the Promotion Department GS1 China, Senior Engineer. She has engaged in article numbering and Auto-ID work, and has years of experience in supply chain management, logistics information standardization and other domains. She was responsible for compiling the GS1 system- based UDI coding specification. As a key participant, she has drafted over 20 national standards on article numbering, barcoding and EDI. She has also participated in doing the researches on the General Specification of Supply Chain and the Article Barcoding and the Entity Code Application System for the Society, ratified by the Ministry of Science and Technology (MOST), the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) and the China National Institute of Standardization (CNIS). Meanwhile, she also played the leading role in some important initiatives and projects, such as food traceability between China and France, implantable medical device traceability and cosmetics market supervision system and mobile commerce.etc. She has been awarded the third prize of Advancing Quality Supervision on Technology by AQSIQ. She holds Master Degree in Project Management of Beihang University. 16:40-17:20 Strategy Study and Practice of Whole-process Visualization of Medical Devices Supply Chain Lu Jian, Deputy Director of logistics in Shanghai Shine-Link International Logistics Co., Ltd. (SLC), EMBA from Shanghai Jiaotong University, AMP from China Europe International Business School. With 15 years working experience at well-known international logistics company, he is an expert in bonded logistics, logistics network design and supply chain management. Now he is the leader for Shine-Link medical device network program construction, REID IT system development and training and talent construction for medical device logistics field. Mr. Lu is the vice chairman for Executive Master Association at Shanghai Jiaotong University, adjunct professor for Shanghai Jiguang Polytechnic College. 18

5 17:20-18:00 Researches on Development of UDI System of Medical Devices and Establishment of Central Database in China Yao Disong, Deputy President of Shanghai Honghui Information Technology Co., Ltd. and General Manager of Shanghai Yidao Information Technology Co., Ltd., has worked in information management software industry over 15 years and in the field of medical device supervision information about 8 years. In 2006, he joined into the first project of China implantable medical device traceability. He took charge of the core software design for Shanghai implantable Medical Device Traceability Supervision System, and helped to establish UDI third party service database that made the high risk medical device traceability management realization in China. This is the first real successful UDI case which supported by the government and being benefit for global strategy development on post-market surveillance. In these 8 years of China hospital information management development, they also have many fruits in hospital logistic management and financial settlement. Now, he is still developing the new function base on UDI for the government, hospital, and health care insurance and medical device adverse event surveillance. 08:30-12:00, August 29 Co-Chair: Yan Liang President of the Shanghai Pudong Medical Device Trade Association, Vice President of Medical Devices Industry Association, and Senior Consultant of policy & regulations and international cooperation, Institute of Food and Drug Safety, Shanghai Food and Drug Administration. He served as the Director of Medical Device Registration Division, Director of Legal Affairs and International Affairs Division of Shanghai Food and Drug Administration, and retired from civil servant position in He has been engaged in the government administrative work for more than 35 years, focusing on the pharmaceutical and medical device industry management and administrative regulations area. He received a Global Leadership award in 2011 from Regulatory Affairs Professional Society (RAPS). In 2006, he used UDI concept to organize a first pilot project of the implantable medical device traceability system in Shanghai in 120 hospitals. In 2009, he headed China medical device nomenclature translation research group to complete the first Chinese version of GMDN (global medical device nomenclature system). He was a member of GHTF AHWG UDI, as well as the first chairman of AHWP STG for device naming and coding harmonization in Asia. Co-Chair: Elise Owen Associate Vice President, Global Strategy and Analysis at the Advanced Medical Technology Association (AdvaMed). In this role, Ms. Owen leads AdvaMed's activities in China with the objectives of increasing opportunities for the medical technology industry in China while, at the same time, supporting China's long-term health and development goals. Prior to joining AdvaMed, she was Director of International Development for the American National Standards Institute (ANSI). In this role, she worked to increase transparency and promote best practices for standardization, regulatory, testing and certification programs in China, India and other emerging economies. Prior to joining ANSI, Ms. Owen was a specialist on standards and technical barriers to trade at the U.S. Department of Commerce's International Trade Administration. In this capacity, Ms. Owen advocated on behalf of U.S. industry positions in government meetings such as the U.S.-China Joint Commission on Commerce and Trade (JCCT) and backstopped key U.S. interventions in the World Trade Organization (WTO). 08:30-08:35 Introduction of the Co-Chairs 19

6 08:35-09:15 Latest Progresses of Technology Studies on Coding of Medical Devices Li Jun, Deputy Director of the Center for Medical Device Standards Management of CFDA Medical Device Standard (Research Institute of Medical Device Standards Management, National Institutesfor Food and Drug Control). She is responsible for technical study of medical device standard system and medical device nomenclature and encoding. 09:15-09:50 UDI Implementation Considerations and Challenges Jackie Rae Elkin, Global Process Owner of Standard Product Identification for Medtronic, Inc. Global Regulatory Affairs. She has been working in the medical device sector for more than 27 years and recognized in the healthcare sector as a leader. She has co-chaired the AdvaMed Auto-Identification Committee since She is one of the founding members of GS1 Global Healthcare and has also been involved in many of the GS1 Global Healthcare work teams. She also chairs the GS1 Global Healthcare Public Policy work group for the medical device sector. In this role, she has engaged with regulators around the world to provide guidance on implementation of global healthcare standards and advocates for movement towards harmonized standards in the global healthcare supply chain. 09:50-10:25 Implementation of UDI Rules by GS1 Standards Brad Depke, Director GS1 Programs at Abbott, including responsibility for the implementation of GLN, GTIN and GDSN programs for the enterprise. He joined Abbott in 1983 and has served in a variety of information technology and program management roles for several Abbott Businesses. Currently, Brad is governing a multi-division program to address the U.S. FDA UDI Rule for Device Class III products. This program will build on the GDSN Solution previously implemented. He earned Bachelor s degrees in business and systems management from Central College, Pella, IA and a MBA from Keller Graduate School of Management with a concentration in project management. 10:25-10:40 Tea Break 10:40-11:20 Establishment of Global UDI Supervision System in China for Promotion of Development of Open Medical Devices Supervision System Yan Liang, President of the Shanghai Pudong Medical Device Trade Association, Vice President of Medical Devices Industry Association, and Senior Consultant of policy & regulations and internationalcooperation, Institute of Food and Drug Safety, Shanghai Food and Drug Administration. He served as the Director of Medical Device Registration Division, Director of Legal Affairs and International Affairs Division of Shanghai Food and Drug Administration, and retired from civil servant position in He has been engaged in the government administrative work for more than 35 years, focusing on the pharmaceutical and medical device industry management and administrative regulations area. He received a Global Leadership award in 2011 from Regulatory Affairs Professional Society (RAPS). In 2006, he used UDI concept to organize a first pilot project of the implantable medical device traceability system in Shanghai in 120 hospitals. In 2009, he headed China medical device nomenclature translation research group to complete the first Chinese version of GMDN (global medical device nomenclature system). He was a member of GHTF AHWG UDI, as well as the first chairman of AHWP STG for device naming and coding harmonization in Asia. 11:20-12:00 Panel Discussion Interact and Communication between All Speakers and Audiences 20