Forum Agenda. 18:00 19:30 Welcome Dinner. 08:30-09:00 Opening of the Forum, Welcome Speeches

Transcription

1 Forum Agenda September 4:Registration, Full Day 18:00 19:30 Welcome Dinner September 5:Opening of the Forum & Plenary Meeting 08:30-09:00 Opening of the Forum, Welcome Speeches Chair:Mr. Zhao Yajun Director-General of China Center for Pharmaceutical International Exchange of SFDA. Opening Speech: Mr.Bian Zhenjia Deputy Commissioner of SFDA. Honored Guest: Ms. Xu Youjun Director-General of Department of International Cooperation of SFDA. Welcome Speech: Mr.Zhang Ruinian General Manager of Johnson &Johnson Medical. Welcome Speech: Cheryl R. Blanchard Zimmer Senior Vice President and Chief Scientific Officer 44

2 09:00-12:00 Plenary Meeting Co-Chair:Mr. Chang Yongheng Deputy Director-General of China Center for Pharmaceutical International Exchange of SFDA. Trustee of the Board of Trustees of GMDN Agency. He used to be Director of the Division of Product Registration of the Department of Medical Devices of the State Food and Drug Administration (SFDA), and Deputy Counsel of the Department of Medical Devices of SFDA. Co-Chair:Nicole Denjoy Secretary General, European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR). She is Leadership in networking and lobbying activities at national, European and international level. She has 24 years experience in the field of Regulatory Affairs and Quality Assurance working with known international healthcare industries and 17 years experience in International & European Standardization committees. It includes a 5 year mandate as President of the French Standard Committee dealing with electromedical equipment. As of today, still a member of the Chairman Advisory Group of IEC TC :00-09:30 Current Situation and Future Development of China s Medical Device Regulatory Supervision Mr. Wang Baoting, Director-General of Department of Medical Device Supervision of SFDA. He was Dean of the Central Hospital of Coal Mining Bureau, Feicheng, Shandong, Deputy Director General of Health Department of Shandong Province, and National Food Safety Supervisor of SFDA successively before the current position. 09:30-10:00 The Revision of the EU Regulatory Framework for Medical Devices Laurent SELLES, in charge of 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 and from the University of Paris VII with an Advanced Studies Degree in Physics of Energy. After in the automotive industry in R&D activities, he joined the European Commission to launch the Polis/Telecities network of European cities. 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). After ensuring the coordination with the health ministries of the Member States, Laurent SELLES represents the European position at the steering committees of GHTF, IMDRF and ICCR. He also Chairs the GHTF/IMDRF working group on Unique Device Identification (UDI) with the aim of permitting traceability on an international level. 10:00-10:30 Annual Review Status in of CMDE, SFDA Mr. Cao Guofang, Deputy Director-General for Center of Medical Device Evaluation SFDA, with main responsibility for the evaluation of active medical device. He used to be Deputy Director of the Division of Product Registration of the Department of Medical Devices of the SFDA, and Director of the Division of Standards of the Department of Medical Devices of SFDA. 10:30-10:45 Tea Break 45

3 10:45-11:10 FDA Unique Device Identification System - Enabling the Transformation of Medical Device Safety Jay Crowley, Senior Advisor for Patient Safety, in FDA s Center for Devices and Radiological Health. He has responsibility for implementing the Unique Device Identification requirements of the 2007 FDA Amendments Act and 2012 FDA Safety and Innovation Act. He holds a master s degree in risk analysis and a bachelor s degree in mechanical engineering. He is interested in developing and implementing new methods and techniques for identifying and resolving problems with the use of medical devices. He has held variety of positions over his 25 years at FDA. 11:10-11:35 the Impact of Medical Device Regulatory Reforms in the US Janet E. Trunzo, Senior Executive Vice President, Technology and Regulatory Affairs for the Advanced Medical Technology Association (AdvaMed) and leads a team of regulatory experts. During her tenure at AdvaMed, she focused her efforts on the passage of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), its reauthorization in 2007 and most recently the negotiation for MDUFA III which was enacted into law as part of the 2012 FDA Safety and Innovation Act. She received her M.S. in health physics from Rutgers University and her B.S. in Chemistry from California University of Pennsylvania.She also concentrates on global regulatory harmonization and represents the U. S. device industry on the Global Harmonization Task Force. She currently Chairs the international Board of Trustees for the Global Medical Device Nomenclature Agency. Prior to joining AdvaMed, Trunzo held positions at Hybritech, Inc., medical device and diagnostics manufacturer and Scripps Clinic and Research Foundation, hospital, diagnostic clinic and research institute. 11:35-12:00 Global Trend in the Development of New Medical Devices -- Adopting New Technologies in the NPD Process Dr. Cheryl R. Blanchard, Senior Vice President and Chief Scientific Officer at Zimmer, responsible for Global Research and New Technology Development, Global Regulatory, Global Medical Affairs, and Zimmer s Biologics business. Prior to joining Zimmer in October 2000, she served in Manager, Professor and Fellow roles at the Southwest Research Institute, the University of Texas Health Science Center, and Oak Ridge National Laboratory, respectively. Bachelor of Science in Ceramic Engineering from Alfred University, Alfred, New York, Masters of Science and Ph.D. in Materials Science and Engineering, both from the University of Texas at Austin. The fields of study encompass many aspects of orthopaedics, including hip and knee reconstruction, early intervention treatments, including biologics, and spine reconstruction. 12:00-13:40 Lunch,VIP Luncheon (VIP Luncheon: with invitation to attend) Co-Chair: Dr.Jiang Feng 14:00-18:00 Plenary Meeting Vice Chairman of China Association for Medical Devices and Director of China Strategic Alliance of Medical Device Innovation. At the meanwhile, he is Deputy Director of Teaching Supervisory Committee of Ministry of Education for Biomedical Engineering, Director of China Instruments Manufacturers Association and Chinese Society of Biomedical Engineering, Executive Director of China Association for Disaster & Emergency Rescue Medicine, Director of Emergency Rescue Equipment Committee. He is also the expert and consultant for National Development and Reform Committee, Ministry of Commerce, Ministry of Industry and Information Technology, China Association for Science and Technology and many National Science Parks. Co-Chair:Janet E. Trunzo Senior Executive Vice President, Technology and Regulatory Affairs for the Advanced Medical Technology Association (AdvaMed) and leads a team of regulatory experts. During her tenure at AdvaMed, she focused her efforts on the passage of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), its reauthorization in 2007 and most recently the negotiation for MDUFA III which was enacted into law as part of the 2012 FDA Safety and Innovation Act. She received her M.S. in health physics from Rutgers University and her B.S. in Chemistry from California University of Pennsylvania.She also concentrates on global regulatory harmonization and represents the U. S. device industry on the Global Harmonization Task Force. She currently Chairs the international Board of Trustees for the Global Medical Device Nomenclature Agency. Prior to joining AdvaMed, Trunzo held positions at Hybritech, Inc., medical device and diagnostics manufacturer and Scripps Clinic and Research Foundation, hospital, diagnostic clinic and research institute. 46

4 14:00-14:35 Development and Prospect of Medical Device Registration Regulations in China Wang Lanming, Deputy Director-General & Inspector-General, Department of Medical Device Supervision, China State Food and Drug Administration (SFDA). M.Sc., MPA, Professor, Senior Engineer. He once worked in university and research institute, and joined the SFDA in Since 1998, he ever served as the Deputy Director-General of the Center for Drug Reevaluation, Deputy Director-General of the Department of Medical Device Supervision. 14:35-15:10 Overview and Future Direction of Japanese Medical Device Regulations Mr Kentaro Azuma, Minisitry of Health Labour and Welfare (MHLW). The specialist for new medical materials, Office of Medical Devices Evaluation, Ministry of Health Labour and Welfare (MHLW), Japan. He experienced several positions in the field of pharmaceuticals and medical devices in the MHLW. He was involved in the revision of Japanese Pharmaceutical Affairs Law in 2002 and the revision of Japan s National Health Insurance Drug Price List in He was appointed the current position on July 2009 and is working for Global Harmonization Task Force (GHTF), and Harmonization by Doing (HBD). He received his MS from the University of Tokyo and his MBA from Duke University. 15:10-15:45 Prospects of China s Medical Device Industry Dr. Jiang Feng,Vice Chairman of China Association for Medical Devices and Director of China Strategic Alliance of Medical Device Innovation. At the meanwhile, he is Deputy Director of Teaching Supervisory Committee of Ministry of Education for Biomedical Engineering, Director of China Instruments Manufacturers Association and Chinese Society of Biomedical Engineering, Executive Director of China Association for Disaster & Emergency Rescue Medicine, Director of Emergency Rescue Equipment Committee. He is also the expert and consultant for National Development and Reform Committee, Ministry of Commerce, Ministry of Industry and Information Technology, China Association for Science and Technology and many National Science Parks. 15:45-16:15 Introduction to Pharmaceuticals and Medical Devices Agency, Japan (PMDA) Dr. Atsushi Tamura, International Coordination officer for Medical Devices, Pharmaceuticals and Medical Devices Agency (PMDA), Japan. After, he joined MHW(MHLW), he dealt with post market safety measurements, medical device review and clinical trial consultation for drugs. In addition, he has an experience to stay a visiting researcher at CDER in US FDA in and to be a visiting scholar at University of Southern California in Currently he is a representative of Japanese regulatory agency for GHTF SC and SG1 and for IMDRF MC. 16:15-16:30 Tea Break 16:30-17:00 Development of Medical Device Standard Administration in China Li, Jingli, Deputy Director of Medical Device Standards Management Center, SFDA (National Testing Institute of Food and Drug Control; Medical Device Standards Management Center), Chief pharmacist, responsible for medical device standards management. She has been the deputy chief for Spot-check management office of SFDA Post-market supervision, responsible for medical device spot-check management. 17:00-17:30 The Regulatory Affairs Consultation on R&D Strategy Mr. Ishikawa, Technical Expert, Division of Office of Review Management Pharmaceutical Affairs Consultation Group on R&D Strategy, Pharmaceutical 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. 47

5 17:30-18:00 KFDA & Korean Medical Device Industry Mr. Piao Xibing,Executive Vice President of KMDICA, Vice President of Korean Medical Device Research Association. Master of Engineering in Yonsei University. He was service engineer of medical device in ROK Army in USA, Planning Manager of construction in hospital in Konkuk University and Purchasing Manager in Konkuk University, Vice Minister of Korean Medical Device Industry Association, CEO of Medipert Consultancy Company, Member of KFDA Medical Device Committee, Committee Member of New Technology Evaluation Association in KATS, Committee Member of Korean Association, ECDF Consultant of Korean Imports and Exports Bank, Member of KOR-U.S.A. Free Deal Negotiation Association in Ministry of Foreign Affairs, Consultant of South Korean consulate in Israel, Consultant of Ministry of Health in Indonesia. (Full Day of Sep. 6 and Morning of Sep.7: Sub-forums) 13:30-16:30, September 7: Plenary Meeting Co-Chair: Mr. Cao Guofang Deputy Director-General for Center of Medical Device Evaluation SFDA, with main responsibility for the evaluation of active medical device. He used to be Deputy Director of the Division of Product Registration of the Department of Medical Devices of the SFDA, and Director of the Division of Standards of the Department of Medical Devices of SFDA. Co-Chair: Mr. Ma Zheng Director of Consulting Division of China Center for Pharmaceutical International Exchange 13:30-14:00 Current Situation and Updates of QMS Inspection in Japan Mr. Kenichi Ishibashi, Inspector, Office of GMP/QMS Inspection, Pharmaceutical and Medical Devices Agency(PMDA), Japan. He is responsible for implementing medical device QMS inspection under Japanese legislation and working to educate Japanese QMS regulation. He is a member of GHTF SG3 and IMDRF MDSAP working group. 14:00-14:30 Establish Scientific Medical Device Technical Evaluation Pattern Shi Xinli, Director of Division II of Evaluation, Center for Medical Device Evaluation, SFDA, Vice Chair for National Technical Committee on Biological Evaluation on Medical Device of Standardization Administration of China, Member of National Technical Committee on Implants for Surgery and Orthopaedic Devices of Standardization Administration of China. She used to be engaged in medical device standardization administration with main responsibility for ISO standard conversion for biological evaluation of medical device. She leaded the compilation of Guidance for Standard of Biological Evaluation on Medical Device (2000). During the technical review for medical device, she established the following regulations: Guidance on Document for Non-active Implantable Medical Device Application, Guidance on Documents for Drug-containing Device Application, Guidance on Medical Device Utilizing Animal Tissues Application. 48

6 14:30-15:00 The Overview of Medical Device Review in PMDA Madoka, Dr. Madoka Murakami, Unit Chief of Division of Regulatory Cooperation in the Office of International Programs since April International harmonization activities such as the Global Harmonization Task Force (GHTF) and the Harmonization By Doing (HBD). Graduated from Keio University in 2003, and then received her master s degree and doctoral degree from Tokyo Medical Dental University in 2005 and She joined PMDA in 2005 and worked as a reviewer of Office of Medical Device till March :00-15:15 Tea Break 15:15-16:30 Interaction Between Center for Medical Device Evaluation of SFDA and All Participants 16:30-17:00, September 7: Lucky Draw, Closing of the Forum Chair:Mr. Chang Yongheng Deputy Director-General of China Center for Pharmaceutical International Exchange of SFDA. Trustee of the Board of Trustees of GMDN Agency. He used to be Director of the Division of Product Registration of the Department of Medical Devices of the State Food and Drug Administration (SFDA), and Deputy Counsel of the Department of Medical Devices of SFDA. 49

7 UDI/GMDN Forum 08:30-12:00, September 6 Co-Chair:Mr. Chang Yongheng Deputy Director-General of China Center for Pharmaceutical International Exchange of SFDA. Trustee of the Board of Trustees of GMDN Agency. He used to be Director of the Division of Product Registration of the Department of Medical Devices of the State Food and Drug Administration (SFDA), and Deputy Counsel of the Department of Medical Devices of SFDA. Co-Chair:Ms. Lindsay Tao Corporate Director, Global Health Policy, Johnson & Johnson, with the responsibility of global regulatory policy across J&J business sectors, including pharmaceutical, medical device and consumer. Before moving to current position, she worked in International Government Affairs Dept, led regulatory government affairs in Asia Pacific & Latin America and was the head of Strategic Medical Affairs of Johnson & Johnson Medical Greater China (including China, HK, Taiwan), responsible for regulatory affairs, medical affairs and clinical research, quality and compliance, health policy and reimbursement, government affairs for over 12 years. She is now concurrently holding leadership positions in industry associations, including: Vice Chair, AHWP; Chair, Asia Pacific Working Group, AdvaMed; Steering Committee Member, APEC Life. 08:30-08:50 Welcome Speech Mr. Wang Baoting, Director-General of Department of Medical Device Supervision of SFDA. He was Dean of the Central Hospital of Coal Mining Bureau, Feicheng, Shandong, Deputy Director General of Health Department of Shandong Province, and National Food Safety Supervisor of SFDA successively before the current position. 08:50-09:25 Using International Experience asreference inexploring the ChineseRoad Mr. YangLianchun, Director of Registration Division II of the Department of MedicalDevice Supervision, SFDA. Chairman of the UDI/GMDN Special Task Group of AHWP. 09:25-10:00 Paving the Way for a Globally Harmonized Post Marketing Surveillance - UDI implementation Plan Laurent Selles, in charge of 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. 50

8 10:00-10:15 Tea Break 10:15-10:50 Device Post-marketing Management is a Global Public Challenge: The US UDI Implementation Process Jay Crowley,Senior Advisor for Patient Safety in FDA s Center for Devices and Radiological Health, responsibility for implementing the Unique Device Identification requirements of the 2007 FDA Amendments Act and 2012 FDA Safety and Innovation Act. Holds a master s degree in risk analysis and a bachelor s degree in mechanical engineering. He is interested in developing and implementing new methods and techniques for identifying and resolving problems with the use of medical devices. He has held variety of positions over his 25 years at FDA. 10:50-11:25 Device Post-marketing Management is a Global Public Challenge: The European UDI Implementation Process Laurent Selles, in charge of 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. 11:25-12:00 Device Post-marketing Management is a Global Public Challenge: The Japan UDI Implementation Process Mr.Ishikawa, Technical Expert, Division of Office of Review Management Pharmaceutical Affairs Consultation Group on R&D Strategy, Pharmaceutical and Medical Devices Agency (PMDA), Japan. Responsible to support consultation activities to promote and activate the innovative medical devices in Japan. In international affairs, he is the member of the UDI working group of IMDRF, as a representative of PMDA. 13:30-18:00, September 6 Co-Chair:Mr. 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. 51

9 Co-Chair:Ms. Carol Yan Senior Director of Regulatory Affairs of Johnson & Johnson Medical China, with responsibilities of JJMC regulatory affairs management as well as providing regulatory strategies to China R&D and NBD functions to drive business growth. She currently is the member of the J&J Medical China Management Board. Carol is actively involved in shaping regulatory environment. She is the Eucomed China Representative. And from 2011, she serves as co-chair of Special Task Group in Asian Harmonization Working Party (AHWP) and Secretariat of AHWP WG 01 (Pre-market & CSDT WG) to drive regulation harmonization activities in Asian countries. 13:30-14:05 China UDI/GMDN Work Panning and Prospect Li Jun, Deputy Director of the Center for Medical Device Standards Management of SFDA Medical Device Standard (Research Institute of Medical Device Standards Management, National Institutes for Food and Drug Control). She is responsible for technical study of medical device standard system and medical device nomenclature and encoding. 14:05-14:35 Global Trend in Unifying Naming of Medical Devices -- Adoption of Global Medical Device Nomenclature Chang Yongheng, Deputy Director-General of China Center for Pharmaceutical Agency. He used to be Director of the Division of Product Registration of the Department of Medical Devices of the State Food and Drug Administration (SFDA), and Deputy Counsel of the Department of Medical Devices of SFDA. 14:35-15:05 Global Medical Device Nomenclature (GMDN) and the Relationship with UDI Mark Wasmuth, CEO, GMDN Agency. He is a Chartered Engineer and Member of IET. He has been at the GMDN Agency since 2010 and has recently been appointed as the CEO. This follows 15 years at the British Standards Institution responsible for Technical Help to Exporters and then International Projects. Before that he was a Senior Engineer with Instron Materials Testing and Molins PLC. 15:05-15:35 Current Situation and Vision of GSI Standard Application in European Medical Institutions Dennis Black, e-business for BD Director, with over 20 years of experience in the healthcare industry, an active participant in the adoption of data standards for use in UDI and other business processes; the GS1 Healthcare U.S. Leadership Team and the GS1 Healthcare Leadership Team. He has participated in related work groups within HSCSC, CHeS, SMI, AdvaMed and MedSC. Dennis is involved in a number of pilot and implementation projects to enable BD and the healthcare industry to benefit from the use of data standards also has responsibilities related to achieving the Perfect Order, leading operational effectiveness initiatives, and other e-business processes. 15:35-15:50 Tea Break 52

10 15:50-16:25 GS1 Resources Support Promoting Global UDI Implementation Strategy Ulrike Kreysa, 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. 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. GS1 Healthcare has the mission to lead the Healthcare sector to the successful development and implementation of global standards. She worked for multiple years in public pharmacies and more than eleven years in the German University Hospital of Aachen, where she held the post of Head of Supplies and Coordination of Group Purchasing for Northrhine-Westfalian University Hospitals in Germany. 16:25-17:00 From Top Solve Unified Coding and Naming is the Foundation to Solve Regulation 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. 17:00-17:30 The Development History of Japan Equipment Coding and UDI Application Hamano Michio,COO & Executive Director GS1Japan / EPC global Japan. Graduated the Faculty of Engineering, University of Tokyo. In the1990s, he was director of Technology Evaluation Division, Industrial Technology Bureau, Ministry of International Trade & Industry (MITI). Between 2001 and 2004, he was director of new Energy and Industrial Technology Development Organization (NEDO). In 2004, he was director General of Statistics Department, Economic & Industrial Policy Bureau, Ministry of Economy, Trade and Industry (METI). 17:30-18:00 GMDN from a Manufacturers Perspective Leighton Hansel, Director, Regulatory Affairs in the Abbott Quality and Regulatory organization. His focus is global device regulatory matters and the coordination of Abbott's device consensus standards and combination product activities; He is convener of ISO/TC 210/WG3, Nomenclature and Symbols for Medical Devices, member of the AAMI Board of Directors, ANSI ISO Council and Global Medical Device Nomenclature (GMDN) Policy Advisory Group. He received a BA chemistry from Miami University (Ohio) and an MBA from Xavier University. He was Program Director in Corporate Regulatory and Quality Science to develop a corporate wide complaint mangement program; the Director of the Division of Surveillance Systems in FDA s Center for Devices and Radiological Health (CDRH); While with the Center, he also served in the Office of Compliance as Director, Division of Product Surveillance with responsibility for the Medical Device Reporting (MDR) and device registration and listing programs. 08:30-12:00, September 7 Co-Chair:Mr. Chang Yongheng Deputy Director-General of China Center for Pharmaceutical International Exchange of SFDA. Trustee of the Board of Trustees of GMDN Agency. He used to be Director of the Division of Product Registration of the Department of Medical Devices of the State Food and Drug Administration (SFDA), and Deputy Counsel of the Department of Medical Devices of SFDA. 53

11 Co-Chair:Mr. 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. 08:30-09:05 Current Situation and Vision of GSI Standard Application in Chinese Medical Area Huang Zhexia, Deputy Director of ANCC Promotion and Application Department, senior engineer. Engaged in articles coding with automatically recognition technology research and promote with full experience of promotion in Supply Chain Management E-business, responsible for medical healthcare promotion. 09:05-09:40 How Industry Respond to the Global Implementation UDI Plan with Suggestion Tom Werthwine, Director, Industry Standards for Johnson & Johnson Customer & Logistics Services, leading the Johnson & Johnson companies effort to comply with Unique Device Identification (UDI). Bachelor of Arts and a Graduate Certificate in Supply Chain Information Systems from The Pennsylvania State University. Co-Chair of the ADVAMED work team on UDI and represents ADVAMED on the IMDRF (International Medical Device Regulators Forum) ad hoc working group on UDI; GS1 Global Healthcare leadership team and the GDSN Inc. board of directors. 09:40-10:15 How Industry Respond to the Global Implementation UDI Plan with Suggestions Jackie Elkin,Global Process Owner of Standard Product Identification Initiatives - Medtronic, Inc. Corporate Global Regulatory Operations, has been working in the medical device sector for more than 25 years. She has been recognized in the healthcare sector as a leader in global standards development for Auto Identification Data Capture (AIDC), the guidance on AIDC standards as related to the FDA s impending legislation on Unique Device Identification (UDI). She has also provided an advisory role in other initiatives involving UDI legislation in both the United States and Globally with the International Medical Device Regulators Forum (IMDRF). One of the founding members of GS1 Healthcare global standards group and has maintained a leadership role since its inception in She has also been involved in many of the GS1 Healthcare work teams developing global standards for healthcare product identification and AIDC. Jackie also Co-Chairs the GS1 Healthcare Public Policy work group and in this role, she has had many opportunities to engage with regulators around the world in a collaborative environment to provide guidance on implementation of global healthcare standards in order to influence movement towards harmonized standards in the global healthcare supply chain. 10:15-10:25 Tea Break 10:25-11:00 UDI based MD 3PL Cheng Junpei, General Manager of Sinopharm Logistics Co.,Ltd., a subsidiary of Sinopharm Group Co.,Ltd. Bachelor degree of Shanghai Institute of Foreign Trade majoring in International Trade Economics. MBA of Nijenrode University of Business. She has served as Vice General Manager of German ASKO Group, General Manager of Edward Keller, Vice general manager of Sinopharm Group Co.,Ltd., General manager of Shanghai Millennium Consulting Firm. 11:00-12:00 Questions and Answers 54

12 In-vitro Diagnostic Devices Forum 08:30-12:00, 9 月 6 日 08:30-12:00 September 6 Co-Chair: Ms. An Juanjuan Director of Division III of Evaluation, Center for Medical Device Evaluation, SFDA. Co-Chair:Jesús Rueda Rodríguez Regulatory Affairs Director for the European Diagnostics Manufacturer s Association (EMDA), responsible for the coordination of industry position and responses in the process of revision and recast of the IVD Directive, Member of the European Commission Medical Devices Expert Group and several key subgroups, including the IVD Technical Group. He focuses on the furthering of interests of EDMA member companies, relative affairs at GHTF, WHO and other international standardization bodies such as ISO and CEN. 08:30-09:20 Clinical Trial for Combination IVD with Drug (Remote Speech) Sally AHojvat, Director, Division of Microbiology Devices, Office of In VitroDiagnostic Device Evaluation and Safety, CDRH/FDA.She has held theposition of Director of the Division of Microbiology Devices, Office of IVDDevice Evaluation and Safety, Center for Devices and Radiological Health at thefda since She is responsible for ensuring that all devices, commercialand non-commercial, which are developed to detect and diagnose infectiousdisease agents are safe and effective and benefit the nation s publichealth. Prior to joining the FDA, Herexperience included 18 years in the IVD Industry, holding positions in IVDresearch and development and manufacturing quality control. The last commercialposition she held was Director of Clinical Research for the Diagnostic Divisionof a major U.S. Pharmaceutical Company. She received a B.Sc.(Hons.) from theuniversityofwales,uk, a M.Sc. in Microbiologyfrom theuniversityofalberta,canada,and a Ph.D. in Biochemistry froml oyolauniversitymedicalschool,chicago. She also completed post-doctoraltraining fellowships in Clinical Chemistry from Loyola Medical School andpharmacology from the University of Chicago. Her numerous research publications and presentations areconcentrated in the fields of Clinical Microbiology, Pharmacology,Neuroendocrinology, Human Subject Protection, Clinical Research, and theregulation of Emerging/Neglected Infectious Diseases and CBRN agents. 09:20-10:05 Key Points about Technical Review of Influenza Virus Reagents Wu Kun, Reviewer of Division III of Evaluation, Center for Medical Device Evaluation, SFDA. 10:05-10:20 Tea Break 10:20-11:05 Introduction of Revised EU 98/79 Directive Jesús Rueda Rodríguez, Regulatory Affairs Director for the European Diagnostics Manufacturer s Association (EMDA), responsible for the coordination of industry position and responses in the process of revision and recast of the IVD Directive, Member of the European Commission Medical Devices Expert Group and several key subgroups, including the IVD Technical Group. He focuses on the furthering of interests of EDMA member companies, relative affairs at GHTF, WHO and other international standardization bodies such as ISO and CEN. 55

13 11:05-11:50 Good Review Practice: MDUFA III & Quality 510 (K) Submission Ms. Hang Gaozhen, Head of Regulatory Affairs, Ortho-Clinical Diagnostics, Inc (OCD), part of the Johnson & Johnson family of companies., a RAC US certified RA specialist, holds a BS in Biopharmaceutical Science, a MS in Pharmacology and a MS in Regulatory Affairs and Health Policy. She is responsible for US and China regulatory submission for clinical chemistry products. She is recently involved in providing comments to FDA 510(k) draft guidance through AdvaMed. She coauthored several peer-reviewed journal articles when she worked at Merck Research Laboratories as an oncology R&D scientist. 11:50-12:00 Questions & Answers 13:30-18:00, 9 月 6 日 13:30-18:00 September 6 Co-Chair:Yang Zhen Yang Zhen, Deputy Director of Institute for Medical Devices Control of National Institutes for Food and Drug Control, graduated from TsingHua University of Peking Union Medical College with microbiology and biochemical medicine PhD degree, Chief Pharmacist. He has participated in the key projects of national Eight-five-year plan to national Eleven-five-year plan, managed two of the key projects of national 863 and 973 plan and issued 32 articles on SCI or National Core Journal as the first author. He is the Editor-in-Chief of The Quality Inspection and Evaluation of Medical Devices work and won the National Science & Technology Achievement Award once and Provincial Science & Technology Achievement Award for five times. As first inventor, he obtained one national patent. Co-Chair:Ms. Gao Jie Ms. Gao Jie, Vice President of Biosino Bio-Technology and Science Inc., responsible for business strategy making and company brand prmotion. As a pediatrician for 7 years in Capital Institue of Pediatrics, then she worked for BJFDA & SFDA for over 11 years. Her job was involved in premarket approval for medical devices, formulation of Provisions for the Registration of Medical Devices in Vitro Diagnostic as well as in charge of drafting and amendment of many medical device regulations. She once worked as Chairman of WG05 (Clinical Evidence Requirments) for AHWP Techinical Committee. 13:30-14:10 Infectious Disease Diagnosis Reagent Standard Research Zhou Cheng, work for National Institutes for Food and Drug Control engaged in scientific research and assay of virus hepatitis reagent and vaccine and collaborative research for virus hepatitis standard, graduated from Xiangya Hospital Central-South University, Member of National Administrative Committee for CRM s. He won the second prize of national scientific and technologic progress at Chinese Academy of Sciences. 14:10-14:50 Traceability Research and Discussion on China IVD Reagent Wu Lebin, Professor of Institute of Biophysics CAS, Chairman of the board and President of Biosino Bio-Technology and Science Inc.., Chairman of In Vitro Diagnostic Professional Committee of the Biophysical Society of China, Member of the committee of National Clinical Medical Measurement Technical Committee and SAC/TC136, Executive Member of first session committee of Clinical Application of Biochemistry and Molecular Biology Branch of Chinese Journal of Biochemistry and Molecular Biology. He is the chairman of Engineering Master Degree Education and Instruction Committee of GSCAS and the special social supervisor of Beijing Institute of Medical Device Testing. He has involved in research and establishment of the Climbing program for the national basic research, development strategy of CAS and study on prediction of future biology. He has presided over the completion of ministry of S&T project Enterprise support for basic research in feasibility and Base construction present situation and the trend and the CAS project Life science, biotechnology and biological industry development strategy research. 56

14 14:50-15:25 European Reference Material and Traceability Management Dr. Fischer Christian, Senior Medical Director of Diagnostic Division, Abbott GmbH, Ph.D. of Philipps- University Marburg, Germany, once served in Surgery, Internal Medicine and Pediatrics departments at affiliated hospital of Philipps-University Marburg and DRK Hospital. After two years experience as a physician assistant in Laboratory medicine of University Central Lab, he worked for BIOSCIENTIA GmbH as the head of Immunology Department. He joined in Abbott Diagnostics Division in 2005 as the Associate Medical Director in international operations department. 15:25-16:00 IVD National Reference Material and High Risk Standard Management Yang Zhen, Deputy Director of Institute for Medical Devices Control of National Institutes for food and drug Control, graduated from TsingHua University of Peking Union Medical College with microbiology and biochemical medicine PhD degree, Chief Pharmacist. He has participated in the key projects of national Eight-five-year plan to national Eleven-five-year plan, managed two of the key projects of national 863 and 973 plan and issued 32 articles on SCI or National Core Journal as the first author. He is the Editor-in-Chief of The Quality Inspection and Evaluation of Medical Devices work and won the National Science & Technology Achievement Award once and Provincial Science & Technology Achievement Award for five times. As first inventor, he obtained one national patent. 16:00-16:15 Tea Break 16:15-16:50 IVD Trend in AACC Cong Yulong, Civil General, Director for Army Medical Laboratory Sciences and Quality Control Center, Chief Physician, Professor, Doctoral Supervisor. He is a member of Health Care Experts Group for Chinese PLA General Hospital and enjoys the special government allowance by the State Council. Mr. Cong Yulong is appointed as Chairman of the 4th National Medical Lab and IVD Standard Committee, Chairman of the 2nd Medical Technology Sub-committee, Certification and Accreditation Administration of the People s Republic of China, Chairman of the 7th PLA Laboratory Medicine Committee, Chairman of the 7th PLA Medical Standard Substance Committee, Chairman of the 2nd Laboratory Physician Branch of Chinese Medical Doctor Association, the 6th Chief Editor for Chinese Journal of Laboratory Medicine. He was once served as a member of the 2nd, a Standing Committee member of the 3rd, Vice Chairman of the 4th, Chairman of the 5th and 6th and 7th of Laboratory Science Branch of Chinese Medical Association. He won many Scientific and Technologic Progress Awards, Excellent Teacher, Medical Education Award. He made 260 papers, of which 23 as the chief editor. As a general chief editor, he completed the compilation of book series Test and Clinic. He made 3 Laboratory Medicine Books for University and College and the first book for national special doctor training Laboratory Medicine. 16:50-17:25 OEM products : Impact on Product Registration and Regulatory Compliance of IVD manufacturers Dr. Hubert Bayer, Director of Global Regulatory Affairs at Roche Diagnostics, PhD in Biology/Human and Animal Virology. He used to work as a research scientist at University of Freiburg for Retrovirus Research and at German Primate Center for HIV research. He is a member of Regulatory Affairs Committee for European Diagnostic Manufacturers Association (EMDA), Chair of Notified Body/ Annex II task force, and Member of Globalization Group. 17:25-18:00 Key Points about Technical Review of Flow Cytometry Diagnostic Kit Ms. Chen Tingting, Reviewer of Division III of Evaluation, Center for Medical Device Evaluation, SFDA. 57

15 08:30-12:00, September 7 Co-Chair:Sun Jingsheng Deputy Chief of Beijing Institution of Medical Device Testing, Senior Engineer, Member of National Technical Committee 136 on System of Medical Clinical Test Lab and in Vitro Diagnostic System of Standardization Administration of China. He was once appointed as Deputy Chief of Center for Medical Device Evaluation, Beijing Drug Administration mainly responsible for pre-marketing review for medical device, testing management of medical device including IVD. Co-Chair:Dr. Petra Kaars-Wiele Senior Director of International Regulatory Affairs/ Packaging and Labeling Administration, Abbott GmbH & Co KG, responsible for all international regulatory affairs, medical event reporting, translations for packaging and labeling in 25 languages and labeling managment at Abbott Diagnostics Division, Ph.D. of Organic Chemistry. She has more than 29 years experience in international regulatory affairs and quality systems for medical device. She is the Chair of EDMA Globalization Task Force; Member of EDMA Regulatory Committee and Technical Forum; Representative of GHTF SG1, IVD Subgroup, EDMA from 2003 to 2012; Member of International Task Force and Blood Safety Working Party of EUCOMED; Member of European Advisory Board of RAPS, member of the Association of Virology and the German Association of Blood Transfusion. 08:30-09:05 Introduction to Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory use Liang Zhenshi, Deputy Director of Electromechanics Lab-1,Beijing Institute of Medical Device Testing(BIMT, Senior Engineer, Master of Engineering. He has long been engaged in electrical safety test of medical electrical equipment and In-vitro diagnostic device (IVD). 09:05-09:40 Effect and Requirement of EU IVD Regulation Standard Jesús Rueda Rodríguez, Regulatory Affairs Director for the European Diagnostics Manufacturer s Association (EMDA), responsible for the coordination of industry position and responses in the process of revision and recast of the IVD Directive, Member of the European Commission Medical Devices Expert Group and several key subgroups, including the IVD Technical Group. He focuses on the furthering of interests of EDMA member companies, relative affairs at GHTF, WHO and other international standardization bodies such as ISO and CEN. 09:40-10:15 IVD Clinical Research Ms. Zhang Li, Chief Pharmacist of Center for Drug Evaluation, SFDA 10:15-10:30 Tea Break 58

16 10:30-11:00 XXX Mr. Wang Jiankang, Technical Secretary of Drug Clinical Trial Institute of the General Hospital of the Air Force, Pharmacist-in-charge. With a long time experience in clinical evaluation of drug and medical device, he made clinical evaluations of 80 medical devices and 100 IVD reagents. He participated in 100 Phase II-IV drug clinical trials. As the main research fellow, he finished 10 Phase I clinical trials. He has published 40 papers. 11:00-11:30 IVD Packaging and Labeling Administration Dr. Petra Kaars-Wiele, Senior Director of International Regulatory Affairs/ Packaging and Labeling Administration, Abbott GmbH & Co KG, responsible for all international regulatory affairs, medical event reporting, translations for packaging and labeling in 25 languages and labeling managment at Abbott Diagnostics Division, Ph.D. of Organic Chemistry. She has more than 29 years experience in international regulatory affairs and quality systems for medical device. She is the Chair of EDMA Globalization Task Force; Member of EDMA Regulatory Committee and Technical Forum; Representative of GHTF SG1, IVD Subgroup, EDMA from 2003 to 2012; Member of International Task Force and Blood Safety Working Party of EUCOMED; Member of European Advisory Board of RAPS, member of the Association of Virology and the German Association of Blood Transfusion. 11:30-12:00 How IVD Manufactures React to Regulations and Technical Standards and Suggestions for Them Mr.Yu Zhiyang,Technical manager of technical regulation department for shenzhen Mindray Bio- Medical Electronics Co.,Ltd,with mainly responsible for the global pre-market submission of In vitro diagnostic medical device, and has extensive knowledge of the registration procedures and requirments of China,CE,FDA,Canada and other markets. 59

17 Cardiovascular and Cerebrovascular System Devices Forum Co-Chair:Shi Xinli 08:30-12:10,September 6 Director of Division II of Evaluation, Center for Medical Device Evaluation, SFDA, Vice Chair for National Technical Committee on Biological Evaluation on Medical Device of Standardization Administration of China, Member of National Technical Committee on Implants for Surgery and Orthopaedic Devices of Standardization Administration of China. She used to be engaged in medical device standardization administration with main responsibility for ISO standard conversion for biological evaluation of medical device. She leaded the compilation of Guidance for Standard of Biological Evaluation on Medical Device (2000). During the technical review for medical device, she established the following regulations: Guidance on Document for Non-active Implantable Medical Device Application, Guidance on Documents for Drug-containing Device Application, Guidance on Medical Device Utilizing Animal Tissues Application. Co-Chair:Zhang Mingdong Director of WW Medical Affairs and Medical Safety Officer. His job includes developing clinical strategy and evidence and clinical study roadmaps, developing and executing evidence generation strategy to support market growth in China, Designing clinical trials, post-approval (Phase IV) studies, health economic studies and outcome research, developing post-market surveillance strategy and managing PMS process, etc., Ph.D. of Molecular Virology, at Baylor College of Medicine, Houston, Texas. He used to be the Medical Officer/Epidemiologist at the Office of In Vitro diagnostic Device Evaluation and Safety, and Epidemiology Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, FDA. 08:30-09:00 About Conditional Approval of Medical Device Shi Xinli, Director of Division II of Evaluation, Center for Medical Device Evaluation, SFDA, Vice Chair for National Technical Committee on Biological Evaluation on Medical Device of Standardization Administration of China, Member of National Technical Committee on Implants for Surgery and Orthopaedic Devices of Standardization Administration of China. She used to be engaged in medical device standardization administration with main responsibility for ISO standard conversion for biological evaluation of medical device. She leaded the compilation of Guidance for Standard of Biological Evaluation on Medical Device (2000). During the technical review for medical device, she established the following regulations: Guidance on Document for Non-active Implantable Medical Device Application, Guidance on Documents for Drug-containing Device Application, Guidance on Medical Device Utilizing Animal Tissues Application. 09:00-09:30 Statistical Challenges of the Medical Device Clinical Trials Li Wei, Director & Professor at Medical Research & Biometrics Center, National Center for Cardiovascular Diseases, Visiting Professor of the Chinese University of Hong Kong, Expert of drug and medical device clinical trial at State Food and Drug Administration (SFDA), Advisor of the Ministry of State Scientific and Technological Commission and Beijing Municipal Science & Technology Commission, Reviewer of many domestic and international medical journals including journals by Chinese Medical Association, Chinese Journal of New Drugs, and American Journal of Epidemiology. She is a member of American Statistical Association, member of the Society of Clinical Trials of USA, member of the Chinese Clinical Trial Society, member of standing committee at China Association of Biostatics, head of PURE research, China at ESC. She has rich experience in clinical trial design & statistical analyses. 09:30-10:00 Cardiovascular device post market surveillance and post approval study program at US FDA Zhang Mingdong, Director of WW Medical Affairs and Medical Safety Officer. His job includes developing clinical strategy and evidence and clinical study roadmaps, developing and executing evidence generation strategy to support market growth in China, Designing clinical trials, postapproval (Phase IV) studies, health economic studies and outcome research, developing postmarket surveillance strategy and managing PMS process, etc., Ph.D. of Molecular Virology, at Baylor College of Medicine, Houston, Texas. He used to be the Medical Officer/Epidemiologist at the Office of In Vitro diagnostic Device Evaluation and Safety, and Epidemiology Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, FDA. 60

18 10:00-10:30 Leveraging AE Report of MedicalDevice Clinical Trial: What are the Global Expectations Zhang Xiaozheng, Director of Medical Safety Monitor Worldwide Clinical Research at Abbott Vascular, MD, MSPH. She used to be an Epidemiologist at the University of Colorado Health Science Center, senior manager of clinical affairs at Edwards Lifesciences, with 20 years global medical device clinical trials management experience. Prior to joining Medical Device companies, Xiaozheng was. She has successfully developed, managed and implemented global clinical trials with records of approvals received for the new medical device/new indication of the medical device submissions in US and OUS. She has a rich background of conducting both pre-and post marketing clinical research studies. 10:30-10:40 Tea Break 10:40-11:10 Comparison of centralized (e.g. China, US, Japan) and decentralized Regulatory System (Europe) for Medical Devices and the expected modifications to the European System Volker Schöwel, Vice President of Global Regulatory and Clinical Affairs in BIOTRONIK, Berlin. He has 27 years experience in medical device industry, working in regulatory affairs with class III medical devices and AIMDs (active implantable medical devices); mainly in the field of urology, gastroenterology, and cardiology. He also has 19 years of experience with the European harmonised conformity assessment procedure and successful interaction with notified bodies and competent authorities in Europe. Moreover, He is Co-Chair of the AKRP (Arbeitskreis Regulatory and Public Affairs) of BVMED in Germany, Member of the International Affairs Task Force and the Regulatory Affairs Committee (RAC) of EUCOMED as well as Member of Regulatory Affairs Professionals Society (RAPS). 11:10-11:40 Biological and Chemical Requirements for Technical Evaluation of Non-active Implantable Medical Devices Zhao Peng, Reviewer of Division II of Evaluation, Center for Medical Device Evaluation, SFDA, member of National Technical Committee on Biological Evaluation on Medical Device of Standardization Administration of China, mainly responsible for technical evaluation of non-active implantable medical device, interventional medical device, medical device utilizing animal tissues and ophthalmic non-active medical device. He attended in compilation of Guide on Document for Medical Device Utilizing Animal Tissues Application, Guide on Document for Non-active Implantable Medical Device Application and Guide on Document for Breast Implants Application. 11:40-12:10 Shelf Life Requirements for Non-active Implantable Medical Devices and Other Common Questions Jia Jianxiong, Reviewer for Division II of Evaluation, Center for Medical Device Evaluation, SFDA, mainly responsible for technical review of cardiovascular and interventional products. He is a member of Cardiovascular Implants Technical Sub Committee, National Technical Committee on Implants for Surgery and orthopedic Devices of Standardization Administration of China. Co-Chair:Zheng Yanyun 13:20-16:20,September 6 Director of Guangzhou Medical Device Supervising &Test Center of SFDA, Master, Associate Researcher, Head of Guangdong Medical Device Quality Supervision and Test Institute, Chairman for Medicine Packaging Material Committee of Guangdong Pharmaceutical Association. 61

19 Co-Chair:Brad Hossack Brad Hossack, Vice President of International Regulatory Affairs at Boston Scientific Corporation, responsible for device registrations in all regions outside of the USA, adjunct professor for Northeastern University s Masters of Science in Regulatory Affairs degree program teaching courses on device regulations in International markets, graduated from the University of Guelph, Canada. He has 25 years of regulatory affairs experience including, 10 years experience in Canada in the Biologics, Pharma, Medical Devices and Hazardous Goods areas with Baxter HealthCare Corp, and 15 years specializing in medical device and combination product registration in International markets with Boston Scientific. 13:20-13:50 Technical Review Requirements for Cardiac Electrophysiological Devices Wang Yuji, Reviewer for Division I of Evaluation, Center for Medical Device Evaluation, SFDA. 13:50-14:20 Regulatory Pathways for Product Changes: A Global Review Brad Hossack, Vice President of International Regulatory Affairs at Boston Scientific Corporation, responsible for device registrations in all regions outside of the USA, adjunct professor for Northeastern University s Masters of Science in Regulatory Affairs degree program teaching courses on device regulations in International markets, graduated from the University of Guelph, Canada. He has 25 years of regulatory affairs experience including, 10 years experience in Canada in the Biologics, Pharma, Medical Devices and Hazardous Goods areas with Baxter HealthCare Corp, and 15 years specializing in medical device and combination product registration in International markets with Boston Scientific. 14:20-14:50 Basic Technical Requirements for Heart Valve Prosthesis and Endovascular Stent Cheng Maobo, Reviewer for Division II of Evaluation for Center for Medical Device Evaluation, SFDA with main responsibility for technical review of cardiovascular and interventional products. He holds a PhD degree in Pharmacy. Mr. Cheng attended in compilation of Guide on Clinical Trial for Drug- Eluting Coronary Stents and Guide on Shelf-life of Non-active Implantable Medical Device. 14:50-15:20 The Progress of Full Degradable Coronary Stents and Its Quality Control Xi Tingfei, Director of the Cross-disciplinary science institute of the biomedical material and tissue engineering center of Beijing University, Director of biomedical material and tissue engineering center of Beijing University in Shen Zhen, Researcher, Doctoral tutor, MS at Beijing Medical School. He used to be the director of the Medical Device Test Center of National Institute of Control of Pharmaceutical and Biological Products, research fellow of the Japanese Pharmaceuticals food hygiene research institute, the international scholar of Australia Health Treatments Administration. He has been long engaged in the field of biomedical materials, artificial organ, reviews of tissue engineering and standard study and worked on 30 national and ministerial key research topics and written 200 articles. He is also the chief editor and participated in compiling 16 books and 15 national or industrial standards. 62

20 15:20-15:50 Neurosurgical Device and Material Promote the Development of Spine Cord Surgery Dr. Xiu Bo, Chief of Neurosurgical Department for Yuquan Hospital of Tsinghua University, Chief Physician, Professor, Doctor of Medicine, the Standing Member of China Spinal Cord Injury Association, International Spinal Cord Society, member of Spinal Cord Injury Department, China Disability and Rehabilitation, editorial member of Neural Regeneration Research (English version), famous spinal cord specialist in China. He is the expert who does the most anisotrophy of cerebromedullary tube operations with microscopic treatment. He won five Scientific Progress Award and Medical Achievement Prizes. He publishes over 70 papers and attends in editing and translation of five works. 15:50-16:20 Interventional Therapy Progress and Innovative Devices on Structural Heart Disease Steve Sorenson, Market Development Manager of Structural Heart at Abbott Vascular. He Proctored 120 MitraClip cases with rich Abbott Vascular Structural Heart experience. He once worked as director of sales and has 12 years experience in selling coronary stents, balloons and other Interventional and Diagnostic CV 16:20-16:35 Tea Break Drug-device Combination Product Forum 16:35-18:10, September 6 Co-Chair:Mr. Xi Tingfei Director of the Cross-disciplinary science institute of the biomedical material and tissue engineering center of Beijing University, Director of biomedical material and tissue engineering center of Beijing University in Shen Zhen, Researcher, Doctoral tutor, MS at Beijing Medical School. He used to be the director of the Medical Device Test Center of National Institute of Control of Pharmaceutical and Biological Products, research fellow of the Japanese Pharmaceuticals food hygiene research institute, the international scholar of Australia Health Treatments Administration. He has been long engaged in the field of biomedical materials, artificial organ, reviews of tissue engineering and standard study and worked on 30 national and ministerial key research topics and written 200 articles. He is also the chief editor and participated in compiling 16 books and 15 national or industrial standards. Co-Chair:Wendy Turner Group Director for Johnson & Johnson s Global Surgery Group, creating and overseeing the Regulatory Operations Center of Excellence, holds Bachelor s degree in Pre-Medicine from East Tennessee State University and a Master s degree in Quality Management from Loyola University, New Orleans. She has achieved several professional certifications, including Regulatory Affairs Professional Society (RAC) and Quality Auditor (CQA) by the American Society for Quality. She has over 25 year s medical device experience in Regulatory Affairs, Quality Management, and Product Development. She joined Ethicon Endo-Surgery, a Johnson & Johnson company in 1992 where she held positions of increasing responsibility and was instrumental in establishing and improving the company s quality systems. As Director of R&D Services, she oversaw product reliability testing, prototype development, and material biocompatibility evaluations. Additionally, she established formal design control processes and developed standard operating procedures. As Director of Regulatory Affairs, she authored and managed numerous US FDA and international submissions. Her team had responsibility for global product registrations and managed a diverse portfolio of medical devices. 16:35-17:10 Technical Review Requirements for Drug-Combination Products Ms. Tian Jiaxin, Reviewer of Center for Medical Device Evaluation, SFDA focus on technical review of dental materials product, Master of Medicine. She attended in compilation of Guidance on Technical Review of Dental Implants (System). 63

21 17:10-17:40 Gelatin / Thrombin Hemostatic Products : Registration Experiences Gary Zhang, Engineering Fellow in the ETHICON Surgical Care Group of Johnson and Johnson involved in research and development of new products, and evaluation and acquisition of new technologies. He has contributed to regulatory filings of new products and re-registrations of existing products to the US FDA and the EMA. His research experiences include both medical devices and biologics. Previously, he had worked in the medical device industry for 6 years. He obtained his B. Eng degree in Polymer Chemical Engineering from Tianjin University, Tianjin, China, and Ph.D. degree in Polymer Science and Engineering from the University of Massachusetts, Amherst campus. He has 12 issued US patents and many other patents are being applied. He published scientific papers in prominent journals such as nature and macromolecules. 17:40-18:10 Combination Products Application in US Gerardine Finn, Vice President of Regulatory Affairs for Medtronic CardioVascular in Santa Rosa, California, currently has global regulatory responsibility for Medtronic's coronary and RDN products. She has over 25 years of experience in the healthcare industry. For the past 15 years she has held regulatory affairs leadership roles in Europe and the US. Prior to joining Medtronic she held roles in R+D, Quality and Operations in a number of small in vitro diagnostic companies. She is a chemistry and biochemistry graduate from the National University of Ireland. 08:30-12:00, September 7 Co-Chair:Ms. Xu Wei Director of Center for Medical Device Evaluation, SFDA, Deputy Chief Physician, Master of Medicine. She once served as the Head of General Affairs of Center for Medical Device Supervision and Registration, SFDA, Director of Medical Device Registration Technical Evaluation Department, Head of Acceptance Office for Medical Device Registration, Head of Medical Device Standard Review Office. Co-Chair:Ms. Lin Yingqing Director of Regulatory Affairs, Health Economics and Government Affairs in Boston Scientific Corporation responsible for regulatory affairs, price administration, health economics, medical insurance, bidding and government affairs, 16 years experience in healthcare industry. She used to be the member of the secretariat for Asian Harmonization Working Party (AHWP) involved in marketing management including international and China domestic market as well as GM of foreign government loan department at GE healthcare. 08:30-09:15 FDA Regulations and Pre-market Review Requirements for Combination Products John Barlow Weiner 64

22 09:15-09:55 Demonstrating Bioequivalence of Medical Devices through the Application of In-vivo and In vitro Correlation (IVIVC) Dr. Yen-Lane Chen, Expert in the areas of local vascular pharmacokinetics for drug-eluting stents, Senior Fellow leading a Pharmaceutical Sciences group in the Drug Coating R&D Department. She has a Ph.D. in Pharmaceutics from the University of Wisconsin-Madison, and did postdoctoral research at the Chemical Engineering Department of the University of Minnesota. She has been with Boston Scientific for 8 years with the focus on the API, excipient, and polymer characterization; Prior to joining BSC, Yen-Lane worked at 3M and ev3 (Covidien). 09:55-10:35 DES Clinical Studies A Global Perspective Judith Jaege, Director of Clinical Research for Medtronic CardioVascular in Santa Rosa, California. Judith has over 25 years of extensive global experience in clinical research for pharmaceutical, medical device, and combination therapies. For the past 15 years, she has held global leadership roles in the area of clinical strategy development and trial execution for interventional cardiology products. Judith currently has global clinical responsibility for Medtronic s Resolute, Resolute Integrity and next generation drug-eluting stents. Prior to joining Medtronic, Judith held clinical research and medical affairs roles in the pharmaceutical and medical device industry. Judith is a graduate of Rutgers University. 10:35-10:50 Tea Break 10:50-11:25 Medicated Dressing Application (3M) 11:25-12:00 Cardiovascular Devices US FDA Regulatory Requirement and Clinical Trial Design An Liu, General Manager of NAMSA China responsible for establishment and development of NAMSA China business, Master of Biostatistics at University of Minnesota. NAMSA is the premier global CRO providing expert regulatory, clinical, and compliance services to medical device and healthcare product manufacturers. He used to be the Director of Biostatistics and Data Management in NAMSA. Before joining in NAMSA, he served as Statistics Manager in Medtronic, Statistician in 3M, and Statistician in the VA Medical Center. He was also an adjunct faculty for St. Cloud State University Master of Application Clinical Research program and an adjunct faculty for Metropolitan State University. An Liu earned a M.S. in biostatistics from University of Minnesota, USA. He holds a M.S. in Environmental Biology from Peking University, China and a B.S. in Ecology from Nankai University, China. 65

23 Optics and Ophthalmic Devices Forum 08:30-12:00, September 6 Co-Chair: Mr. He Tao Head of Hangzhou Center for Medical Equipment Quality Supervision and Testing of SFDA, Head of Zhejiang Institute for the Control of Medical Device, professor level Senior Engineer. He is also served as Chairman of Technical Sub-committee of National Medical Optics and Instruments Standardization focus on medical device testing management, research of medical optics standard, testing technology and methods. Co-Chair: Ms. Wang Huiling Head of China s Regulatory Affairs, J&J Vision Care responsible for regulatory and government affairs, Representative of quality management, Master of Biology, over 12 years experience in regulatory affairs and quality management, expert in pre-market approval and post-market surveillance. She once worked for many renowned international and domestic companies and is involved in AHWP and various standardization communities. 08:30-09:15 About the New Regulation of Non-Corrective Colored Contact Lens under Medical Device Supervision Ms. Lu Hong, Reviewer for Division II of Evaluation, Center for Medical Device Evaluation, SFDA with main responsibility for technical review of ophthalmic device and non-active implantable products. She joined in compilation of Guide on Technical Review of Contact lens Care Products, Guide on Documents for Contact Lens Application. She holds a master degree in biomedical engineer in Capital Medical University. Ms. Lu once worked for National Institution for Food and Drug Control and Product Standard Review Office, Center for Medical Device Evaluation, SFDA involving in product standard review. She publishes several articles in core journals. 09:15-09:55 National Standards of Contact Lens Mr. He Tao, the Head of Hangzhou Center for Medical Equipment Quality Supervision and Testing of SFDA, Head of Zhejiang Institute for the Control of Medical Device, professor level Senior Engineer. He is also served as Chairman of Technical Sub-committee of National Medical Optics and Instruments Standardization focus on medical device testing management, research of medical optics standard, testing technology and methods. 09:55-10:30 Improvement for Efficiency, Safety and Comfort of Contact Lens Xie Peiying, Head of Optometry Research Center at Peking University Health Science Center, Doctor of Medicine, Post Doctorate. She is also the Deputy Group Leader of Ophthalmic Academy, Optometry Group of Chinese Medical Association, member of Brachymetropia Research Key Laboratory of the Ministry of Health, member of National Medical Metrics Technological Committee, member of National Technical Committee on Medical Optics Standardization Administration of China. Ms. Xie Peiying serves as a member of Ophthalmic Contact Lens Association of US and Japan, International Contact Lens Educators Association. She works in Chinese Journal of Ophthalmology, Chinese Journal of Strabismus & Pediatric Ophthalmology, Chinese Journal of Optometry Ophthalmology and Visual Science as the editorial member. She used to be a Deputy Research Fellow of Beijing Tongren Hospital and the Head of Contact Lens Center. She has published over 200 papers about optometry and ophthalmology and finished 19 academic articles as the editor, chief editor and editorial member. 66

24 10:30-10:45 Tea Break 10:45-11:20 Network Sales Situation and Trend for Pharmaceutical Product Wang Huiling, Head of China s Regulatory Affairs, J&J Vision Care responsible for regulatory and government affairs, Representative of quality management, Master of Biology, over 12 years experience in regulatory affairs and quality management, expert in pre-market approval and postmarket surveillance. She once worked for many renowned international and domestic companies and is involved in AHWP and various standardization communities. 11:20-12:00 Establish an Effective Procedure for Application Document Mr. Liu Zhitao,General Affairs Division of Center for Medical Device Evaluation, SFDA. Optics and Ophthalmic Devices Forum & Odontological Devices Forum 13:30-18:00, September 6 Co-Chair:Ms. Shi Xinli Director of Division II of Evaluation, Center for Medical Device Evaluation, SFDA, vice chairman for National Technical Committee on Biological Evaluation on Medical Device of Standardization Administration of China, member of National Technical Committee on Implants for Surgery and Orthopaedic Devices of Standardization Administration of China. She used to work for Bureau of Administration Supervision, SFDA with main responsibility for Standardization Administration of Medical Device. She leaded in ISO standard conversion for biological evaluation of medical device and compilation of Guidance for Standard of Biological Evaluation on Medical Device (2000). Since 2000, she has been involved in technical review for no-active implantable medical device. She established the following regulations: Guidance on Document for Non-active Implantable Medical Device Application, Guidance on Documents for Drug-containing Device Application, Guidance on Medical Device Utilizing Animal Tissues Application. Ms. Shi publishes many papers in several professional journals. Co-Chair: Mr. Chen Hao Assistant Dean of the Affiliated Eye Hospital of Wenzhou Medical College (Zhejiang Eye Hospital), Associate Professor of ophthalmology, associate chief physician, Doctor of Ophthalmology & Optometry in the New England College of Optometry. He served as the China representative for International Center for Eyecare Education (ICEE), International Association of Contact Lens Educators (IACLE), member of ISO TC172/SC7 WG10 and Special Working Group of Standardization Administration of the People's Republic of China. His expertise includes ophthalmology & optometry, medical ophthalmology materials, new medical device technology R&D, and clinical evaluation. He publishes 23 academic papers and owns 12 patents. 67

25 13:30-14:15 Technical Review Requirements for Medical Endoscope Mr. Lianghong, Reviewer of Division Ⅰof Evaluation, Center for Medical Device Evaluation, SFDA. 14:15-14:50 New EU Guidance on Post-Market Clinical Follow-up for Medical Device Ms. Lian Hongwen, North District Manager of Beijing Branch of TechnischenUberwachungs-Vereine (TÜV) SUD Group China. Responsible for medical device system certification and CE product evaluation. She once worked in Quality and Standard Department of China National Medical Equipment Industry Corporation. Her responsibility includes set-up and modification of medical device national standard and industrial standard, harmonization work for China Secretariat of International Organization for Standardization and Supervision and Inspection of National Medical Device. When worked in Standard Division of Quality Department, SFDA, she was mainly involved in set-up and modification of drug national and industrial standard and harmonization work for China Secretariat of IEC/TC62. Besides, she was once appointed to be responsible for product certification, manufacturing license, and product registration review at Medical Device Department of SFDA. 14:50-15:25 Quality Control and Specification in Ophthalmic and Optometry Devices Clinical Trial and Scientific Research Innovation Mr. Chen Hao, Assistant Dean of the Affiliated Eye Hospital of Wenzhou Medical College (Zhejiang Eye Hospital), Associate Professor of ophthalmology, associate chief physician, Doctor of Ophthalmology & Optometry in the New England College of Optometry. He served as the China representative for International Center for Eyecare Education (ICEE), International Association of Contact Lens Educators (IACLE), member of ISO TC172/SC7 WG10 and Special Working Group of Standardization Administration of the People's Republic of China. His expertise includes ophthalmology & optometry, medical ophthalmology materials, new medical device technology R&D, and clinical evaluation. He publishes 23 academic papers and owns 12 patents. 15:25-15:40 Tea Break 15:40-16:15 Trabecular Metal Technology used in Dental Implants Mr. Hai Bowen, Ph.D., Director of Research, Zimmer Dental. He completed his Bachelor degree in Materials Science in 1992 and Master degree in Materials Physics in 1995 both from the Department of Materials Science and Engineering at Tsinghua University. He did his Ph.D. in Biomaterials in Leiden University, the Netherlands. He has 20 years of research and development experience in the areas of biomineralization, biomaterials, surface modifications and tissue regeneration for orthopedic, spine and dental applications. He is now overseeing the Global Research and Clinical Affairs Department at Zimmer Dental. 16:15-16:50 The Control and Prevention on Dental Medical Device Cross-infection Chief of technical department of Guangdong Medical Devices Quality Surveillance and Test Institute from 2004 to present, also serves as the secretary-general of National Technical Committee 99 on Dental Materials and Equipments of Standardization Administration of China, Equipments Subcommittee (SAC/TC99 SC1) and Guangdong Pharmaceutical Association on Packing Materials Professional Committee. Senior Engineer, Master Degree,On-job Ph.D. 68

26 16:50-17:25 Dental Implant Surface Modifications Mr. Hai Bowen, Ph.D., Director of Research, Zimmer Dental. He completed his Bachelor degree in Materials Science in 1992 and Master degree in Materials Physics in 1995 both from the Department of Materials Science and Engineering at Tsinghua University. He did his Ph.D. in Biomaterials in Leiden University, the Netherlands. He has 20 years of research and development experience in the areas of biomineralization, biomaterials, surface modifications and tissue regeneration for orthopedic, spine and dental applications. He is now overseeing the Global Research and Clinical Affairs Department at Zimmer Dental. 17:25-18:00 European Requirements for the EN1642 revision Kerry Foote was appointed Director of Regulatory Affairs and Quality Assurance for Zimmer Dental in January 2000, responsibilities include the management of Regulatory Submissions, Regulatory Compliance, Quality Assurance/Control, Document Control, Training, Complaint Handling, Microbiology, Chemistry, and Quality Systems (including the implementation and maintenance of Six Sigma, Kaizen, and Lean programs). He brings 20 years of experience in Microbiology, Quality and Regulatory Affairs. He holds a Bachelor of Science degree in Microbiology with a minor in Chemistry from Brigham Young University in Provo, Utah. Odontological Devices Forum 08:30-12:00, September 7 Co-Chair:Ms. Lin Hong Director of Medical Device Quality Supervision, Inspection Center, SFDA. Director of Peking University Peking University of Oral Cavity Medical Equipment Test Center; Director, researcher, medical doctor of Peking University of Oral Cavity Material Research Center; (SAC/TC 99) Secretary general. Chinese Journal of Stomatology on dental materials professional committee; the biological evaluation of medical devices technical committee. Co-Chair: Mr. Hai Bowen Director of Research, Zimmer Dental. He completed his Bachelor degree in Materials Science in 1992 and Master degree in Materials Physics in 1995 both from the Department of Materials Science and Engineering at Tsinghua University. He did his Ph.D. in Biomaterials in Leiden University, the Netherlands. He has 20 years of research and development experience in the areas of biomineralization, biomaterials, surface modifications and tissue regeneration for orthopedic, spine and dental applications. He is now overseeing the Global Research and Clinical Affairs Department at Zimmer Dental. 08:30-09:10 Establishment of Technical Review Structure and Operation Mr. Zhang Shiqing, General Affairs Division of Center for Medical Device Evaluation, SFDA. 09:10-09:40 Patient Specific Abutments CAD/CAM Ms. Melissa Burbage, Associate Director of Regulatory Affairs, Zimmer Dental. Responsibilities include Regulatory Compliance for good manufacturing practices and Regulatory Submissions for registering all Zimmer Dental products in over 60 countries. Bachelor of Science degree in Microbiology with ah minor in Chemistry from Oregon State University. Zimmer Dental offers medical devices including dental implants and regenerative product made form synthetic material, bovine or human. She has over 10 years experience in the medical device industry. 69

27 09:40-10:10 Human Tissue and Bone used in Dental Ms. Caroline A. Hartill, Executive Vice President and Chief Scientific Officer; Chief Scientific Officer. She earned a Bachelor s degree with honors in Health Sciences from Birmingham University Medical School in England, as well as a Master s degree in Management from the University of Wolverhampton in England also earned Master s level credits in Sterilization Science from Manchester University. She joined RTI in November 2001 and was named Vice President of Quality Assurance and Regulatory Affairs in January In her role at RTI, she oversees all research and development, quality assurance, regulatory affairs and clinical studies. She has served as a board member for BioFlorida and is chair for the Tissue Products Workgroup of the Advanced Medical Technology Association (AdvaMed). She also serves as chair of the Accreditation Committee of the American Association of Tissue Banks (AATB) and is an appointed member of the Agency for Healthcare Administration (AHCA), State of Florida Organ and Tissue Transplant Advisory Committee. For the previous 18 years, she worked in the areas of technology development and market approvals as a consultant working with many major and start-up biotechnology and medical device companies worldwide. 10:10-10:25 Tea Break 10:25-11:00 Notice of Oral Material Registration Inspection Mr. Xu Yongxiang, Secretary of Peking University Peking University of Oral Cavity Medical Equipment Test Center, Chinese Stomatological Association Oral Materials Committee. In 2007, got doctor science of materials and engineering in Tsinghua University. Mainly engaged in oral materials teaching, scientific research and testing, participated in a number of oral materials standard revision. 11:00-11:30 Clinical Requirements for the US and EU A Comparison Ms. Alexander founded Alquest, a dedicated medical device CRO, in 1993 with a vision to providing comprehensive, integrated services to device manufacturers. Under her leadership, the company expanded to include regulatory, clinical and compliance services for devices, biologics and combination products serving customers worldwide. She successfully led the team that sold Alquest to NAMSA in 2009 and has remained with NAMSA as Vice President with a business development focus. She is noted for her strategic regulatory and clinical insights and has personally supported more than 100 US medical product approvals. Her experience includes all classes and types of products including coated stents and iontophoretic drug delivery systems. An experienced trainer and public speaker as well as quality system advisor, she is often requested to present at conferences on topics such as combination product regulation, product approval submissions, global strategies, and FDA enforcement issues. She has a B.S. in Biology from Iowa State University and M.S. in Technical Communications from the University of Minnesota. 11:30-12:00 Bovine Material used in Dental Ms. Caroline A. Hartill, Executive Vice President and Chief Scientific Officer; Chief Scientific Officer. She earned a Bachelor s degree with honors in Health Sciences from Birmingham University Medical School in England, as well as a Master s degree in Management from the University of Wolverhampton in England also earned Master s level credits in Sterilization Science from Manchester University. She joined RTI in November 2001 and was named Vice President of Quality Assurance and Regulatory Affairs in January In her role at RTI, she oversees all research and development, quality assurance, regulatory affairs and clinical studies. She has served as a board member for BioFlorida and is chair for the Tissue Products Workgroup of the Advanced Medical Technology Association (AdvaMed). She also serves as chair of the Accreditation Committee of the American Association of Tissue Banks (AATB) and is an appointed member of the Agency for Healthcare Administration (AHCA), State of Florida Organ and Tissue Transplant Advisory Committee. For the previous 18 years, she worked in the areas of technology development and market approvals as a consultant working with many major and start-up biotechnology and medical device companies worldwide. 70

28 Orthopaedics and Surgical Instruments Forum 08:30-12:00, September 6 Co-Chair: Ms. Qi Baofen Director-General for Tianjin Medical Devices Supervision and Testing Center, SFDA, Senior Engineer. Also Vice Chairman for National Technical Committee on Implants for Surgery and Orthopedic Devices of Standardization Administration of China (SAC/TC110). Co-Chair: Ms. WinnieShi Winnie Shi, Regulatory Affairs Manager of Biomet China, graduated from China Pharmaceutical University, having been engaged in the regulatory affairs on Medical device for more than ten years. Join Biomet since 2004, responsible for the product registration in China for Global facilities, and in charge of Tender and pricing affairs and QA compliance and Training. 08:30-09:10 Inspection on Implants for Surgery Mr. Song Duo, Senior Engineer, Deputy Director-General for Tianjin Medical Device Supervision and Testing Center, member of National Technical Committee on Implants for Surgery and Orthopaedic Devices Of Standardization Administration of China, vice chairman of Technical Committee on Materials and Orthopaedic Implants, member of National Technical Committee on Dental Materials and Equipment of Standardization Administration of China. He has many years experience in inspection, standardization and GMP of implant for surgery. He attended in compilation of Foundation for Technology of Medical Device Supervision, Detailed Rules for Implant Medical Device, Good Manufacture Practice for Medical Device and Guidance on Review for Vascular Stents as well as over 20 national and industrial standards. He also publishes many academic papers. 09:10-09:40 Australia Joint Registry and Its Value in Clinical Decision-making Shamiram Feinglass, Vice President for Global Medical and Regulatory Affairs at Zimmer, Inc., responsible for global leadership in strategy development and execution of all corporate programs in Clinical Affairs, Market Access (Health Economics and Reimbursement), and Regulatory Affairs, as well as all Zimmer businesses including reconstruction, spine, dental, trauma, biologics and surgical products. She has over 15 years of legislative and regulatory experience and is involved in numerous national and international health policy activities, including work with ICOR, being a member of MedCAC and AdvaMed. Graduate of Smith College and the Emory Schools of Medicine and Public Health and completed Internal Medicine Residency at Oregon Health Sciences University, Preventive Medicine Residency at Emory School of Medicine, and the Robert Wood Johnson Clinical Scholars Program at the University of Washington, a former medical officer with CMS (Medicare). 09:40-10:15 Clinical Trial of Orthopaedic Medical Devices Professor Qiu Guixing, Academician for China Academy of Engineering, Director of Surgery Department, Director of Orthpeadics, Chief Physician in Peking Union Medical College, Ph.D. Supervisor, expert who enjoys the special government allowance, ex-chairman of Chinese Orthopedic Association, the first who bring China classification method of scoliosis internationally. He owns 5 patents and wins many national prizes including two National Science & Technology Prograss Awards (second class), Beijing Science & Technology Awards (second class), Chinese Medical Science & Technology Prizes (second class), Third Prize of Development of Science and Technology of Education Ministry of China, Second Prize granted by Ministry of Health. Mr. Qiu, as the chief editor or chief translator, finished several books including new spine surgery technology, intramedullary nail fixation technique, orthopedic surgery, etc. He publishes 376 papers in both overseas and domestic journals. 71

29 10:15-10:30 Tea Break 10:30-11:00 Clinical Data Presentations for Orthopedic Device Applications Ms. Xie Jing, Vice President of Global Clinical Research, Biomet, leading clinical research and clinical supervision team. She works on clinical research activities and strategy development of orthopaedic products, biological products, sports medicine and trauma products for medical reconstruction including publication of clinical trials of pre-market and post market approval and clinical research material after clinical trial, clinical protocol design, trial size assessment and management, statistical methods, clinical evaluation and cost-effectiveness analysis, clinical value assessment, Material and relative program analysis. Bachelor of Chemistry at Xiamen University, Master of Computer at Purdue University, Master of Chemistry, Ph.D of Materials at Alabama University, member of MEDCAC and AJRR. 11:00-11:30 Post Market Clinical Surveillance of Orthopedic Devices Kathy Harris, Director of Regulatory Strategy for Asia Pacific for DePuy, Johnson & Johnson Company. She has over 30 years experience in medical products regulations for medical devices, pharmaceuticals and consumer products. Her experience includes Regulatory Affairs, Quality Systems, Sterilization, Packaging and Technical Services. Holds a bachelor s degree in Chemistry and a Masters of Business Administration and have certifications in Regulatory Affairs, Quality Engineering and Quality Auditing. 11:30-12:00 Biologics Products Overview and How US/EU Regulate Dr. Cheryl R. Blanchard, Senior Vice President and Chief Scientific Officer at Zimmer, responsible for Global Research and New Technology Development, Global Regulatory, Global Medical Affairs, and Zimmer s Biologics business. Her research field involves in many aspects of orthopaedics including hip and knee reconstruction, early intervention treatments (biologics included), and spine reconstruction. Prior to joining Zimmer in October 2000, she served as head at the Southwest Research Institute, professor at the University of Texas Health Science Center, and research fellow at Oak Ridge National Laboratory, respectively. Bachelor of Science in Ceramic Engineering from Alfred University, Alfred, New York, and Master of Science and Ph.D. in Materials Science and Engineering at the University of Texas at Austin. 13:20-18:10, September 6 Co-Chair:Liu Bin Mr. Liu Bin, Deputy Head for Division II of Center for Medical Device Evaluation, SFDA, Associate Chief Physician, member of Subcommittee on Materials and Orthopedics Implants of National Technical Committee on Implants for Surgery and Orthopedic Devices of Standardization Administration of China. He has 20 years experiences in Orthopedic clinical research and technical evaluation for medical device. He is the main author of orthopedic part of Foundation for Medical Device Supervision and Administration. Besides, he is engaged in establishment of Guide on Documents for Non-active Implantable Device Registration and Guide on Verification Virus Inactivation of Allogeneic Bone. Co-Chair:Harris Kathy Kathy Harris, Director of Regulatory Strategy for Asia Pacific for DePuy, Johnson & Johnson Company. She has over 30 years experience in medical products regulations for medical devices, pharmaceuticals and consumer products. Her experience includes Regulatory Affairs, Quality Systems, Sterilization, Packaging and Technical Services. She holds a bachelor s degree in Chemistry and a Masters of Business Administration and have certifications in Regulatory Affairs, Quality Engineering and Quality Auditing. 72

30 13:20-13:50 Pre-clinical Testing of Artificial Joints Jin Zhongmin, Professor at the University of Leeds, Distinguished Professor for 'Thousand People Plan' at Xi'an Jiaotong University, Cheung Kong Chair Professor at Xi'an Jiaotong University, Director for Tribology Institute of Chinese Mechanical Engineering Society, Deputy Head for Basic Group, Chinese Orthopaedic Association, Bachelor of Xi'an Jiaotong University, PhD of Mechanical Engineering at the University of Leeds. He publishes 200 SCI papers on artificial joint tirbology, organizes 5 international biotribology conferences and plays a leadership role in European Union COST (533) on Biotribology activities. He won many international prizes including Thomas Stephen Prize from UK Mechanical Engineering Society, Water-Arbitration Prize of outstanding paper from UK Mechanical Engineering Society and Joint Research Fund for Overseas Natural Science of China. 13:50-14:20 Clinical Evidence of Trabecular Metal Technology in Orthopaedic Implants Yao Jianqing, PhD, Senior Director of Research and Development, Zimmer Asia Pacific Region. He has 25 years experience of research and development in biomechanics, biomaterials and tissue engineering. He has been conducting extensive orthopaedic research and published 136 scientific articles in international journals/conferences. He is currently serving on the Editorial Boards of two leading international journals ( Journal of Engineering in Medicine, the official journal of Institution of Mechanical Engineers; Cartilage, the official journal of International Cartilage Repair Society). He was awarded Tribology Bronze Medal and Thomas-Stephen Award by the Institution of Mechanical Engineers (UK) for his research on tribology. 14:20-14:50 Biological Evaluation of Ceramic Implant Materials Katharina von Struensee, Manager Regulatory Affairs, CeramTec GmbH. Holds a diploma engineer of pharmaceutical chemistry. She has several years experience in Regulatory Affairs for pharmaceuticals and medical devices, with an expert knowledge in the field of implants and implant materials. 14:50-15:25 How to Make the Osteoporosis Diagnosis Instrument and Treatment Instrument Benefit Maximization and Harm Minimization Liu Zhonghou, Chairman for Osteoporosis Committee of China Gerontological Society (OCCGS), Chief Editor for Editorial Board of Chinese Journal of Osteporosis, Research Fellow. As the most active academic societies in China, OCCGS and Chinese Journal of Osteporosis are the pioneers in osteoporosis, bone and mineral research fields and have numbers of cooperation activities with international academic committees and journls. He makes an outstanding contribution to osteoporosis and bone mineral research. Graduated from Jilin Medial University, he once worked on osteoporosis in Kanazawa Medical University as the visiting scholar. He is the chief editor for reference books in osteoporosis fields including osteoporosis, bone mineral and clinical application, osteoporosis diagnosis and publishes more than 100 papers. 15:25-15:35 Tea Break 15:35-16:05 The Process for Taking Novel Implants to Market, From Start to Approval, Using US As an Example Mark Gordon, Vice President, Global Regulatory and Clinical Affairs, Synthes, Inc., responsible for leading the global regulatory and clinical organizations dedicated to the support of Synthes divisions and geographies; Received a Bachelor s and Master s degree in Bioengineering from the University of California, San Diego; He has over 31 years experience in the medical device industry, including 23 years in Regulatory Affairs, Clinical Affairs, and Quality Assurance and eight years in Research and Development. He has previously held regulatory leadership positions in large and small organizations, including: Vice President, Global Regulatory Policy and Advocacy, Boston Scientific; Vice President, Regulatory and Clinical Affairs, Quality Assurance, Medtronic; LuMend, Inc.; Kyphon, Inc. Other experiences including: Co-Chairman, AdvaMed Technology and Regulatory Committee; Member, MDMA FDA Regulatory Strategy Group; FDA and Hill Negotiations, MDUFA2/FDAAA (AdvaMed, MDMA, Boston Scientific); Chairman, Regulatory Affairs Professional Society Board of Directors; Industry Member, FDA Grassroots Task Force; US Representative, Global Harmonization Task Force, Clinical Study Working Group; Industry Member, FDA Risk Communication Advisory Committee. 73

31 16:05-16:35 Highly Crosslinked UHMWPE: in Vitro Testing and 10+ Years of Outstanding Clinical Performance Yao Jianqing, PhD, Senior Director of Research and Development, Zimmer Asia Pacific Region. He has 25 years experience of research and development in biomechanics, biomaterials and tissue engineering. He has been conducting extensive orthopaedic research and published 136 scientific articles in international journals/conferences. He is currently serving on the Editorial Boards of two leading international journals ( Journal of Engineering in Medicine, the official journal of Institution of Mechanical Engineers; Cartilage, the official journal of International Cartilage Repair Society). He was awarded Tribology Bronze Medal and Thomas-Stephen Award by the Institution of Mechanical Engineers (UK) for his research on tribology. 16:35-17:05 Post market surveillance management of Medical Device Ms. Xie Jing, Vice President of Global Clinical Research, Biomet, leading clinical research and clinical supervision team. She works on clinical research activities and strategy development of orthopaedic products, biological products, sports medicine and trauma products for medical reconstruction including publication of clinical trials of pre-market and post market approval and clinical research material after clinical trial, clinical protocol design, trial size assessment and management, statistical methods, clinical evaluation and cost-effectiveness analysis, clinical value assessment, Material and relative program analysis. Bachelor of Chemistry at Xiamen University, Master of Computer at Purdue University, Master of Chemistry, Ph.D of Materials at Alabama University, member of MEDCAC and AJRR. 17:05-17:35 Contrast the Chinese and US Regulatory Processes for Orthopedic Devices Mark Gordon, Vice President, Global Regulatory and Clinical Affairs, Synthes, Inc., responsible for leading the global regulatory and clinical organizations dedicated to the support of Synthes divisions and geographies; Received a Bachelor s and Master s degree in Bioengineering from the University of California, San Diego; He has over 31 years experience in the medical device industry, including 23 years in Regulatory Affairs, Clinical Affairs, and Quality Assurance and eight years in Research and Development. He has previously held regulatory leadership positions in large and small organizations, including: Vice President, Global Regulatory Policy and Advocacy, Boston Scientific; Vice President, Regulatory and Clinical Affairs, Quality Assurance, Medtronic; LuMend, Inc.; Kyphon, Inc. Other experiences including: Co-Chairman, AdvaMed Technology and Regulatory Committee; Member, MDMA FDA Regulatory Strategy Group; FDA and Hill Negotiations, MDUFA2/FDAAA (AdvaMed, MDMA, Boston Scientific); Chairman, Regulatory Affairs Professional Society Board of Directors; Industry Member, FDA Grassroots Task Force; US Representative, Global Harmonization Task Force, Clinical Study Working Group; Industry Member, FDA Risk Communication Advisory Committee. 17:35-18:10 Registration Requirements for Hip Joint Prostheses Mr. Liu Bin, Deputy Head for Division II of Center for Medical Device Evaluation, SFDA, Associate Chief Physician, member of Subcommittee on Materials and Orthopedics Implants of National Technical Committee on Implants for Surgery and Orthopedic Devices of Standardization Administration of China. He has 20 years experiences in Orthopedic clinical research and technical evaluation for medical device. He is the main author of orthopedic part of Foundation for Medical Device Supervision and Administration. Besides, he is engaged in establishment of Guide on Documents for Non-active Implantable Device Registration and Guide on Verification Virus Inactivation of Allogeneic Bone. 08:30-12:00, September 7 Co-Chair:Huang Jiahua Director General for Shanghai Medical Device Supervision and Testing Center, SFDA, Chief for Shanghai Center for Medical Device Testing, Senior Engineer. He once served as Deputy Director General for Shanghai Center for Drug and Medical Device Evaluation, responsible for technical evaluation for medical device registration in Shanghai. He is the main author for Medical Device Registration and Administration. He obtained Second Class of Shanghai Scientific and Technological Progress Award and Second Class of Excellent New Products Achievement Award of both China and Shanghai Municipality separately. 74

32 Co-Chair:Chadaporn (Miang) Tanakasemsub Regional QA/RA Vice President of Asia Pacific, Zimmer, Inc. Member of senior leadership team in Asia Pacific, Japan & Global Quality and Regulatory Affairs team. Holds a Bachelor degree of Pharmacy in Chulalongkorn University and MB. A degree of Mahidol University in Thailand. She has more than 16 years experience in regulatory affairs with numbers of international drug and device companies with board endeavor in regulatory affairs, clinical research, reimbursement, government Affairs and quality assurance in Asia Pacific including Japan. She is vice chairman of AHWP TC, member of GHTF SG02 (postmarket surveillance), involvedin harmonization activities of GHTF, AHWP and ACCSQ, one of the speakers and consultants of Malaysian medical devices regulatory framework formalization in early stage. Recently, she was also nominated to be one of the experts in medical devices area to WHO. Currently, she is nominated to be one of WHO medical device experts. 08:30-09:10 Application and Implementation of Objective Performance Criteria in Orthopaedic Products Ms. Liu Yinghui, Reviewer for Center for Medical Device Evaluation, SFDA responsible for technical review of orthopedic implantable products. She holds a PhD degree in Pharmacology. She has been involved in compilation of Guide on Technical Review of Virus Inactivation Validation for Allogeneic Implantable Medical Device. 09:10-09:40 PEEK Standard Update and High Important Technique Application for PEEK and General Introduction for PEEK Family Craig Valentine, Global Regulatory Affairs Director, Invibio Ltd, member of ASTM sub-committee, polymer expert, responsible for all polyarylether ketone (PAEK) standards. He has a very solid Polymer Chemistry and Technology background and more than 20 years working experience on polymer especially on PEEK polymer technology. He is familiar with requirements on peek based medical device from main regulatory authorities and provides regulatory and technical support to customers globally. In addition, he extends the FDA Master File for peek material which brings big convenience to the customer on FDA approval. He serves as a polymer expert supporting Invibio s material development efforts, and manages those activities related to products within the current portfolio. To date, Craig has co-authored 19 patents. 09:40-10:10 Good Quality Governance of Orthopaedics Products Chadaporn (Miang) Tanakasemsub, Regional QA/RA Vice President of Asia Pacific, Zimmer, Inc. Member of senior leadership team in Asia Pacific, Japan & Global Quality and Regulatory Affairs team. Holds a Bachelor degree of Pharmacy in Chulalongkorn University and MB. A degree of Mahidol University in Thailand. She has more than 16 years experience in regulatory affairs with numbers of international drug and device companies with board endeavor in regulatory affairs, clinical research, reimbursement, government Affairs and quality assurance in Asia Pacific including Japan. She is vice chairman of AHWP TC, member of GHTF SG02 (postmarket surveillance), involvedin harmonization activities of GHTF, AHWP and ACCSQ, one of the speakers and consultants of Malaysian medical devices regulatory framework formalization in early stage. Recently, she was also nominated to be one of the experts in medical devices area to WHO. Currently, she is nominated to be one of WHO medical device experts. 10:10-10:25 Tea Break 10:25-10:55 Quality Assurance of Clinical Trials Gemma Ritchie, Vice President of Regulatory and Clinical Affairs for Emerging Markets and International Markets at Smith & Nephew (Shanghai), Master of Public Health degree. She has 20 years experience in phase III and IV clinical trials for drugs and medical devices and has worked in a wide variety of therapeutic areas. She once served for the National Health Medical Research Centre (NHMRC) Clinical Trials Department at the University of Sydney, Australia for 10 years, a clinical trial methodology research unit, conducting large scale trials, as well developing and implementing quality assurance systems for clinical trials. In the following 11 years, she has been working in pharmaceutical and medical device companies, holding senior positions in regulatory and clinical affairs departments. Besides she has rich experience in teaching and clinical research especially in Asia-Pacific countries. 75

33 10:55-11:25 The New Standard for Composite Materials Based on a High-purity Alumina Matrix with Zirconia Reinforcement: ISO Dr. Jens Hagen, Head of Regulatory Affairs, CeramTec GmbH, over 10 year experience in International Regulatory Affairs of Medical Devices and. PhD in Pharmaceutical Biology. He was long-term member of the Federal association of German medicinal product manufacturer, Dental Device Regulatory task force. His experience includes Biological evaluations, Risk Management, Sterilization, Quality Systems, Regulatory Requirements for OEM manufacturers and worldwide regulative strategies. 11:25-12:00 ISO Standards and Their Appropriate Uses for Orthopaedic Products Yao Jianqing, PhD, Senior Director of Research and Development, Zimmer Asia Pacific Region. He has 25 years experience of research and development in biomechanics, biomaterials and tissue engineering. He has been conducting extensive orthopaedic research and published 136 scientific articles in international journals/conferences. He is currently serving on the Editorial Boards of two leading international journals ( Journal of Engineering in Medicine, the official journal of Institution of Mechanical Engineers; Cartilage, the official journal of International Cartilage Repair Society). He was awarded Tribology Bronze Medal and Thomas-Stephen Award by the Institution of Mechanical Engineers (UK) for his research on tribology. 76

34 Medical Imaging Devices Forum 08:30-12:00, September 6 Co-Chair:Ms. Liu Xiaoyan Director of Evaluation Division I of Center for Medical Device Evaluation, SFDA. Co-Chair:Ms. Feng Yan The vice-chairman of COCIR in China. She is also a member of AHWP and has been working in the field of healthcare equipment regulatory affairs for many years, being responsible for various regulatory affairs, such as the standards of healthcare equipments, registration and certification, quality monitoring, security regulation. She has extensive experience in the field of global standards, law and regulatory systems for different countries in the healthcare equipment industry. Currently, she is the director of quality, regulatory and government affairs department of Philips Healthcare China. 08:30-09:15 Main Points of Medical Device Software Technical Review Peng Liang, Reviewer of Division I of Evaluation, Center for Medical Device Evaluation, SFDA. 09:15-09:50 Latest Situation for Medical Devise Software in Japan Mr. Susumu Takahashi, Chairman of International Committee, Japan Medical Imaging and Radiological Systems Industries Association(JIRA); Vice chairman of Committee on Electromedical Systems, Japan Electronics & Information Technology Industries Association (JEITA); Vice chairman of General Administration Committee, Japanese Association of Healthcare Information Systems Industry (JAHIS); Member of Asia NGS-WG, The Japan Federation of Medical Devices Associations (JFMDA); Senior Staff, Global Business Operations Department, Toshiba Medical Systems Corporation; Senior Staff, 3R (Refurbishment/Reuse/Recycle) Promotion Department, Toshiba Medical Systems Corporation. 09:50-10:25 Medical Imaging Device and Its Diagnosis Integration Mr. Dai Jianping, He used to be the President of Beijing Temple of Heaven Hospital and the Chief of Nerve Radiation Lab of Beijing Neurosurgical Institute. He holds the awards for experts from the State Council and enjoys the special subsidies from the government as being the expert made outstanding contribution. He was the Vice Chairman of China Hospital Information Management Association (CHIMA), Vice Chairman of China Association for Medical Devices Industry (CAMDI), Managing Director of Chinese Medical Doctor Association and China Medical Association. 10:25-10:40 Tea Break 77

35 10:40-11:15 InternationalConsiderations and Regulatory Aspects for Medical Software Dr. Peter Linders, Director of Global Quality and Regulations for Philips Healthcare. He has been with Philips Healthcare for more than 25 years. He was involved in X-ray imaging R&D for over 14 years, in various management positions. In that period, he became increasingly involved in development of international standards for regulatory purposes. In 1999 he became director of development of standards and regulations at Philips Healthcare. Since then, he has been active in the development of standards and regulations at the European and international level. He is chair of CENELEC/TC 62 and is involved in technical committees of IEC and ISO. He is also active in European industry associations related to medical devices, in particular in COCIR, where he is chair of the Technical and Regulatory Affairs Committee. For COCIR, he participated in GHTF as member in Study Group 1. Since early 2012, he is member in Working Group 1 of AHWP, with special interest in medical software. 11:15-11:50 Clinical Trial of Imaging Device s New Technologies Mr. Becker has been with Siemens for more than 20 years and has worked in a variety of leadership functions in IT, Supply Chain Management, Service and Quality & Regulatory Affairs in Germany and the USA. After 4 years as the Vice President of Quality, Regulatory Affairs & EHS for the Siemens Ultrasound business, Mr. Becker was appointed in August 2009 the global position of Vice President Quality Management, Process Management & Regulatory Affairs for the Healthcare Sector of Siemens. 11:50-12:00 Tea Break 13:30-18:00, September 6 Co-Chair:Wang Jianjun Deputy Head of Liaoning Institution for Medical Device Testing, Professor-level Senior Engineer, Bachelor of Wireless Technique in Dalian University of Technology, MS of Biomedical Engineering in Northeastern University; a member ofsubcommittee 1 on Medical X-ray Equipment and Appliance of National TechnicalCommittee 10 on Medical Electrical Equipment of Standardization Administration of China. Mr. Wang Jianjun once served as Deputy Director and Assistant to Head of Liaoning Medical Device Test Institution. With rich experience and wideknowledge in medical device testing, he hosts and joins in testing for various medical X-ray units both at home and abroad. Besides, Mr. Wang Jianjun takes responsibility for establishment and amendment of many technical standards and publishes number of technical papers. Co-Chair:XXX (Siemens) 13:30-14:15 Safety Standard of Medical X-Ray Equipment (Third Edition) Hou Yaofang, Deputy Director of Standard Lab, Liaoning Medical Device Test Institute. 78

36 14:15-14:55 Prospect of IEC rd Edition in China He Jun, Director of Test Lab II, Shanghai Center for Medical Equipment Quality Supervision and Testing, SFDA, Secretary-General for National Technical Committee on Medical Electrical Equipment of Standardization Administration. 14:55-15:35 Transition Plan of IEC rd Edition Naoki MOROOKA,Expert for Pre-market Approval and QMS for Medical Device; Chairman of Regulation committee of Japan Industries Association of Radiological Systems (JIRA); Member of QMS/RA committee of The Japan Federation of Medical Devices Association (JFMDA); Member of GHTF SG1 as the representative of JFMDA; Member of IMDRF-RPS-WG as the representative of DITTA/JIRA; Manager for QMS, Regulatory Affaires and Standards of Medical Systems Division of Shimadzu Corporation. 15:35-15:50 Tea Break 15:50-16:30 IEC rd Transition and Introduction to YY0505 Yu Xinhua, Deputy Director for Institute of Medical Device Standard Administration, National Institute for Food and Drug Control. He once served as director of standard administration division II, Center for Medical device Standardization Administration, SFDA. 16:30-17:10 MRI Development and Prospect Jin Zhengyu, Chief physician, professor, Ph.D. supervisor. Director of the radiology department of the Chinese Academy of Medical Sciences and Beijing Union Medical College Hospital, Beijing Union Medical. College Hospital Academic Committee,a member of Board of Education, Peking Union Medical College Degrees Committee, Textbook Committee members. In diagnostic imaging and interventional radiology for more than 20 years, was promoted to professor, chief physician in 1996, 1995, he was appointed Master instructor in 2000 before any of the PhD supervisor. Respectively to the United States, Germany learning the professional skills, and completed fellowship studies in the United States receive a diploma. Now the Ministry of Education national key disciplines, Peking Union Medical College The charge of China Medical Imaging Department. 17:10-17:50 Development and Technical Evaluation Requirements of MRI Mr. Yang Pengfei, Reviewer of Division I of Evaluation, Center for Medical Device Evaluation, SFDA holding responsibility for technical review of imaging instruments including magnetic resonance imaging system. He holds a Doctor degree in engineering. 17:50-18:00 Questions and Answers 79

37 Co-Chair: Xia Yiwu 08:30-12:00, September 7 Deputy Director of Hubei Medical Device Quality Supervision and Testing, SFDA, Technical Leader, Chief Pharmacist, Senior Engineer, Member of Advisory Committee of Hubei Drug (Medical Device) Side Effects and Group Unexpected Event Emergency Treatment, Director of Wuhan Branch, Chinese Pharmaceutical Association, Executive Member of Wuhan Pharmaceutical Management Committee, Inspector of Hubei Drug GMP Inspection. He has long been engaged in testing and biological safety evaluation for drug and medical device. Co-Chair:Mr. Sun Zhuohui Enrolled in GE Healthcare since 2009 as business manager of regulatory affairs, organized Working Group for Standardization GE China that has been actively joining the implementation of IEC :2005 and IEC (YY0505 new edition) directed by the SFDA. keen on activities held by Department of Medical Device Supervision; giving comments on formulating normative administrative documents; giving comprehensive explanation of Chinese laws and regulations in GE and meanwhile help confirm substantial effects such as the right understandings of the staff and implementation. 08:30-09:20 Technical Evaluation Requirements for Imaging Ultrasonic Diagnostic Equipment Guo Zhaojun,Reviewer of Division I of Evaluation, Center for Medical Device Evaluation, SFDA. Mainly responsible for ultrasound diagnosis device products. 09:20-10:05 Common Questions about Performance Test of Ultrasonic Diagnostic Equipment Li Jing, Deputy Director of Evaluation Division I of Center for Medical Device Evaluation, SFDA. Engaged in Medical device testing for more than 6 years. Mainly responsible for ultrasound device products detection. 10:05-10:20 Tea Break 10:20-11:05 Various Aspects of Medical Imaging Devices Regulation Consideration Mr. Wang Xinbing, Technical manager of technical regulation department for Shenzhen Mindray Bio-Medical Electronics Co., Ltd, with mainly responsible for the international regulatory affair of all medical products, including concerned environment regulations, and has extensive regulatory practice of the registration procedures and implementation of regulations of main international areas, such as EU, Asia Pacific, NA, LA, Middle East and CIS. 11:05-11:50 Safe Use and Maintenance of Medical Devices, Product Upgrades Sarah Wang, Master degree, RA Director of GE Healthcare. She had been with GE for more than 13 years. She held positions on regulatory affairs in GE Healthcare for X-ray, ultrasound, patient monitor, anesthesia, and respiratory device pre-market approval. She accumulated abundant experiences in medical device pre-market approval and post-market surveillance. 11:50-12:00 Questions and Answers 80

38 Medical High Molecule Products and Consumables Forum 08:30-12:00,September 6 Co-Chair:Ms.Deng Jie Director of Evaluation Division Ⅳ of Center for Medical Device Evaluation, SFDA. Co-Chair:Yen-Lane Chen Dr. Yen-Lane Chen, Senior Fellow leading a Pharmaceutical Sciences group in the Drug Coating R&D Department. She has expertise in the areas of local vascular pharmacokinetics for drugeluting stents. She has a Ph.D. in Pharmaceutics from the University of Wisconsin-Madison, and did postdoctoral research at the Chemical Engineering Department of the University of Minnesota. She has been with Boston Scientific for 8 years, focus on the API, excipient, and polymer characterization. Prior to joining BSC, Yen-Lane worked at 3M and ev3 (Covidien). 08:30-09:20 Safety Evaluation of New Plasticizer in Medical High Molecule Products Mr. Yang Xiaodong, Reviewer of Evaluation Division Ⅳ of Center for Medical Device Evaluation, SFDA. 09:20-09:55 Extraction and Quantitation of Plasticizer in Medical Device Ms.Wei Zhao, Director, Regulatory Affairs at Covidien in the US. Leading regulatory affairs team in providing regulatory direction and strategy for new product design and development, medical device commercialization application and registration world-wide, and post market product surveillance. Earned a Master Degree of Biochemical Toxicology from Iowa State University in the US; Graduated from Beijing Medical University with Medical Degree; Ophthalmologist in Beijing Tong-Ren Hospital. 09:55-10:45 Approach to global harmonization of biological safety evaluation for medical devices Extraction methods, hemocompatibility and PVC plasticizers Keisuke Sakaguchi, Principal Research Manager of TERUMO Corporation R&D Headquarters Evaluation Center. Head of GLR sub-working group of Japan Federation of Medical Devices Associations.Co-chairperson of Japanese committee of ISO/TC194 (Nominated Expert of ISO/ TC/194). Diplomate of Japanese Society of Toxicology 81

39 Keisuke Nakahashi, General Manager of Terumo Corporation Environmental Management Department. Vice-chairman of Environmental committee of Japan Federation of Medical Devices Associations. Leader of WG11 in Japanese committee of ISO/TC194 (Nominated Expert). 10:45-11:00 Tea Break 11:00-11:50 Chemical Characterization of Medical Devices in Support of Biological Safety Dr. Hollie Beckord, Biocompatibility Manager, Boston Scientific Corporation. She earned her Ph.D. in organic chemistry in 2003 from the University of MN. She received a B.A. in 1997 from the University of St. Thomas in St. Paul, MN, with concentrations in chemistry and biology. She has worked for Boston Scientific Corporation for over eight years in various roles. She joined BSC in 2003 as a chemist supporting quality control operations for DES combination products in the Maple Grove, MN analytical laboratory. In 2008, she began supervising the analytical lab before she moved on to become Manager of Analytical Design Assurance in 2009, where she provided analytical and technical quality assurance to medical device R&D. She joined the Biocompatibility and Toxicology department in 2010 as a chemist supporting the chemical characterization of materials in BSC medical devices. In 2012, she began managing the Biocompatibility group and now oversees biocompatibility operations in the US and Ireland. Mr. Don R. Pohl, Senior Project Manager at NAMSA. He graduated from The Ohio State University and has 18 years experience in NAMSA specializing in medical device biocompatibility issues. He is also a member of Association for the Advancement of Medical Instrumentation (AAMI). 11:50-12:00 Questions and Answers September6,13:30-18:00 Co-Chair:Ms.Deng Jie Director of Evaluation Division Ⅳ of Center for Medical Device Evaluation, SFDA. Co-Chair:Mr. Udo Graf Vice President of Research and Development for Mentor Worldwide LLC, a Johnson & Johnson company and leading provider of aesthetics products for plastic and reconstructive surgery. He received a Bachelor of Science in Physics from the University of Texas Pan American and a Masters degree in Physics from Texas A&M University. He joined Mentor in 1994 as a Research Engineer and has served in a management role with the company since During his tenure at Mentor, he has overseen various areas of Research and Development including Analytics and Urology. 82

40 13:30-14:15 Related Technical Issues about Registration Application of Absorbable Material Products Ms. Ju Shan, Reviewer of Evaluation Division Ⅳ of Center for Medical Device Evaluation, SFDA. 14:15-14:50 Shelf-life/Stability Evaluations Mr.Zhu Hongyi, system engineering manager for Covidien Emerging Markets of Asia. Responsible for building the system team and technology for Covidien China and making system design for China developed products. PHD in engineering and Master and Bachelor degree in Physics, Zhejiang University. Before he joined Covidien, he was the system and sustaining engineering manager of GE healthcare China. Product reliability design and reliability tests were part of his responsibility in his career. 14:50-15:25 The Preclinical /Chemical Testing Requirements for Breast Implants Udo Graf, Vice President of Research and Development for Mentor Worldwide LLC, a Johnson & Johnson company and leading provider of aesthetics products for plastic and reconstructive surgery. He received a Bachelor of Science in Physics from the University of Texas Pan American and a Masters degree in Physics from Texas A&M University. He joined Mentor in 1994 as a Research Engineer and has served in a management role with the company since During his tenure at Mentor, he has overseen various areas of Research and Development including Analytics and Urology. 15:25-16:00 Some issues about Gradable Stents Evaluation Mr. Gu Hanqing, Professor of Biomedical Engineering and Urology Surgery at Tianjin Medical University, Research Fellow, Doctoral and Post-doctoral Supervisor at Educational Center. He is the Deputy Director-General and General Secretary of Chinese Society of Biomedical Engineering, Chairman of Artificial Organs Branch of Chinese Society of Biomedical Engineering, Vice Chairman of Biomaterial Branch of Chinese Society of Biomedical Engineering, Deputy Director-General of Tianjin Biomedical Engineering Society, Standing Director of Medical Instrument Branch of Chinese Instrument Manufacturers Association, a Member of Chinese Institute of Electronics, Vice Deputy- General of Life Electronics Branch. Mr. Gu holds positions in many professional technical journals as the chief editor or vice chief editor. He has published 116 papers and made many books as the chief editor or editorial member. He was awarded as the outstanding experts by the State Council and enjoys the special government allowance. Besides he received Tianjin Labor Model and Medals. 16:00-16:10 Tea Break 16:10-16:45 XXX Ms. Shi Yanping, Deputy Head for Shandong Quality Inspection Center for Medical Devices, Researcher of Engineering Technology Application, Vice Chairman of National Technical Committee 248 on Biological Evaluation on Medical Device of Standardization Administration of China. She has many years experiences in research, testing, standardization, quality management on sterile medical device, like medical polymer. She participates in experimental verification, compilation as well as modification of many standards. Ms. Shi Yanping is one of the participants for compilation or modification of Guide on Biological Evaluation Standard for Medical Device, Production Management of Disposable Sterile Medical Device, Medical Device Registration and Supervision, Foundation for Technology of Medical Device Supervision. She publishes many academic papers. 83

41 16:45-17:20 Medical Device Process Validation Wang Huifang, Dept. Manager, Senior Auditor of Quality Management System and Training Advisor for Beijing Hua Guang Certification of Medical Devices Co., Ltd., takes responsibility for medical device quality management certification and audit, training for company QMS and safety management. She is a Bachelor of Plastics Engineering and a Master of Polymer Material in Chengdu University of Science and Technology. As the medical device GMP auditor, she is involved in SFDA issues including medical device GMP drafting and training after promulgation. 17:20-18:00 Chemical Properties Requirements for Medical High Molecule Products Mr. Yang Xiaodong, Reviewer of Evaluation Division Ⅳ of Center for Medical Device Evaluation, SFDA. 84