In-vitro Diagnostic Devices Forum

Transcription

1 In-vitro Diagnostic Devices Forum 08:30-12:00 September 12 Co-Chair: Ms. An Juanjuan Director of Division III of Evaluation, Center for Medical Device Evaluation, SFDA. 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 promotion. As a pediatrician for 7 years in Capital Institute 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 Requirements) for AHWP Technical Committee. 08:30-08:35 Introduction of the Co-Chairs 08:35-09:10 EU IVDD Update 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. 09:10-09:45 Technical Requirements for Registration of Virus Specific IgM Reagent Li Yaohua, Deputy Director of Evaluation III Department of Center for Medical Device Technical Evaluation, CFDA, Engineer, responsible for evaluation of clinical laboratory analytical instruments and reagents. He is a member of National Technical Committee 421 on Biochip of Standardization Administration of China. He has been involved in compilation of many product guides for registration application including reagents of tumor maker, Influenza virus nucleic acid, virus specific IgM, flow cytometry, etc. 09:45-10:15 Regulatory Paths and Performance Evaluation of Companion Diagnostic Tests Songbai Wang, Director of Biostatistics and Bioinformatics at Janssen Diagnostics Inc, Johnson & Johnson Company. He has worked in medical and clinical research arena in both academic and industrial settings for more than 25 years. In the last 13 years his research focused on clinical trial design and data analysis methodology and its application for in-vitro-diagnosis tests and medical devices. He was lead statistician for over 30 regulatory submissions including NDA, PMA, BLA and 510k in areas of cancer, autoimmune diseases and infectious diseases, and was co-author for over 20 peer-reviewed papers and/or presentations. He earned a professional degree of medicine from Tongji Medical University and MSPH with focus in biostatistics from University of South Florida. His career includes employment at China-Japan Friendship Hospital, University of Michigan Comprehensive Cancer Center, Parexel International Corporation, Gen-Probe Incorporated, and Johnson & Johnson. 18

2 10:15-10:30 Tea Break 10:30-11:00 IVD Shelf Life Management From R & D Perspective Debra J. Rasmussen, Senior Director of Global Regulatory Affairs at Johnson & Johnson s Janssen Pharmaceuticals based in Raritan, New Jersey. Johnson and Johnson established a new group, Janssen Diagnostics. For Janssen Diagnostics, she is responsible for development of regulatory strategy, policy, and registration of the in vitro diagnostic devices associated with Johnson and Johnson drug development and commercialization. She holds an MBA from St. Mary s College and a Bachelor of Science degree in Bacteriology/Immunology from the University of California, Berkeley. Her regulatory and quality career has spanned both large and small companies and both US and global programs. She has been in diagnostics for over 25 years and gained her experience working at Bio-Rad Laboratories, Roche Molecular Systems, Chiron Corporation, Applied Imaging Corporation, and Visible Genetics. 11:00-11:30 Deciding When to Submit a 510(k) for a Change to an Existing IVD assay" in FDA Lesley Traver, VP of Quality, Regulatory, and Clinical Affairs for the Chemistry, Automation, Immunoassay and IT (CAI) Business Unit at Siemens Healthcare Diagnostics. She is an active member of APS and ASQ and is a certified Six Sigma black belt. She holds a MS in Neuroendocrinology from Miami University of Ohio and a Bachelor of Science in Biology from Bucknell University. Previous roles include Vice President of Worldwide Regulatory Affairs and Design Quality at J&J Diabetes Care, Director of Quality, Regulatory and Compliance at Ortho Clinical Diagnostics, and various technical and leadership roles in R&D and QA/RA at ETHICON, Inc. During her career, she has had the opportunity to lead substantial Quality Management System improvement efforts. 11:30-12:00 IVD Software Markus Preidel, Senior Director of Software Engineering Department, Siemens.. He also is chair of the Siemens Healtcare Diagnostics Software Council. S. He started his career as software developer and project manager in an engineering firm in northern Germany. In 1997 he moved to Behring Diagnostics, which became a part of Siemens Healthcare Diagnostics. His first position was in head of Software Verification at the Schwalbach Engineering site. Later he moved to Software Engineering at Schwalbach and is now head of this department. ince many years Markus is strongly involved in the EDMA software task force. In this function he plays an active role in the EDMA s work on standards and regulations. 13:30-18:00 September 12 Co-Chair:Mr.Li Yaohua Deputy Director of Evaluation III Department of Center for Medical Device Technical Evaluation, CFDA, Engineer, responsible for evaluation of clinical laboratory analytical instruments and reagents. He is a member of National Technical Committee 421 on Biochip of Standardization Administration of China. He has been involved in compilation of many product guides for registration application including reagents of tumor maker, Influenza virus nucleic acid, virus specific IgM, flow cytometry, etc. Co-Chair:Ms. Jing Zhang Regulatory Affairs and Government Affairs Director, Greater China, BD, is responsible for regulatory and government affairs in China, Taiwan and Hong Kong. MS. Zhang holds a MS in Bioengineering from Pennsylvania State University.She has over 20 years Regulatory and Quality experience in medical device industry (medical devices, IVD, capital equipment) and 3 years experience in biotech. Before this role, she was Director of Regulatory Affairs and Compliance in Nippon BD, held responsibilities for developing and implementing regulatory strategies, plans and policies for Nippon BD to meet business needs.ms. Zhang also worked in the US for over 15 years and has extensive experience in U.S. and EU device regulations and working knowledge of US and EU biologics/cell therapeutics regulations. 19

3 13:30-13:35 Introduction of the Co-Chairs 13:35-14:10 Requirements for Clinical Trial of HIV Reagent Dong Jinchun, Reviewer for Evaluation III Department Divsion of Center for Medical Device Evaluation, CFDA, Associate Chief Technician, responsible for evaluation of clinical laboratory analytic instruments and reagents. He is a member of National Technical Committee 136 on System of Medical Clinical Test Lab and in Vitro Diagnostic System of Standardization Administration of China. He has been involved in compilation of many technical guides including guides of accuracy research method, Kyodex Reagent and HIV reagent clinical trial. 14:10-14:40 Re-used Instruments: Accepted Process Within a Quality System Dr. Petra Kaars-Wiele, Senior Director International Regulatory Affairs, Division Labeling Administration, Abbott GmbH & Co KG, responsible for all international regulatory matters, medical event reporting, managing translation for 25 languages and labeling activities at Abbott Diagnostics Division. Diploma and Ph.D. in Organic Chemistry. Almost 30 years experience in Regulatory Affairs and Quality Systems for Medical Device, She has experience in building Quality Management System according 9001 and and has passed a lead auditor training in Since then she has used that knowledge in training, setting up a QMS or consulting in that field internally and externally. She is the Chairwoman of the EDMA Globalization Working Party; Advisor to AHWP Technical Committee; Member of the EDMA Regulatory Committee and Technical Forum; Member of the International Task Force and the 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; Past Member of the GHTF SG1, IVD Subgroup representing EDMA, from 2003 until :40-15:10 IVD UDI Andrea Guentner, Senior Director of Regulatory Affairs, Siemens. She started her career in the Regulatory Affairs Department of Behringwerke AG many years ago. Since then the company merged with other companies and was renamed Behring Diagnostics, Dade Behring and Siemens Healthcare Diagnostics Products GmbH in Since 2005 she became Senior Manager, Regulatory Affairs (RA) and heading an RA team in charge of international product registrations in specified countries, among others China, as well as European animal epidemic protection law. Besides international product registrations Andrea is participating in international teams to streamline global regulatory requirements and proceedings. She is a member of EDMA and VDGH animal-by-products working groups. Since April 2013 she became an RA team member in the company s international UDI team. 15:10-15:40 Quality Audits as a Proactive Approach to Regulatory Compliance Christina Yang, Vice President, Global Regulatory Affairs of the Diagnostics business, she provides global regulatory guidance, strategy and policy recommendations to executive management. She has a B.S. in Biology from National Taiwan Normal University, Taipei, Taiwan and a Ph.D in Zoology from Iowa State University, Iowa. She brings over twenty years experience in regulatory and clinical affairs, quality assurance, quality engineering and quality control. Previously, Dr. Yang served as Senior Vice President, Regulatory Affairs and Quality of Gen-Probe from 2007 until Prior to that, Dr. Yang was the Vice President, Quality and Regulatory Affairs of Focus Diagnostics, owned by Quest Diagnostics, consisting of laboratory services, clinical trial and IVD production units with focus on infectious disease. Immediately prior, Dr. Yang held a variety of management positions in R&D, quality systems, diagnostic operations, and technical manufacturing. From 1987 to 1995, Dr. Yang served in quality control, biochemistry and allergy, and organic chemistry management positions at Diagnostic Products Corporation in Los Angeles. Dr. Yang is a Regulatory Affairs Certified (RAC), an ISO9000 certified lead auditor and a Certified Quality Auditor (CQA). 15:40-15:55 Tea Break 20

4 15:55-16:25 IVD Co-development of Companion Diagnostics and Therapeutics Pamela Swatkowski, Director of Regulatory Affairs ABBOTT MOLECULAR INC. Responsible for strategic regulatory programs including companion diagnostics regulatory and business development support, product lifecycle management, and global product registration for the molecular diagnostics product line. She received a bachelors degree in biology from Loyola University of Chicago. Notable are her twenty plus years as a regulatory and quality professional in the in vitro diagnostics and medical device industry. Pamela is the Regulatory Affairs lead, responsible for global regulatory strategy development and worldwide approval for the Abbott ALK FISH test used in identifying those non-small cell lung cancer patients eligible for treatment with the Pfizer drug XALKORI (crizotinib). She gained Food and Drug Administration (FDA) approval to begin global ALK FISH testing to enroll lung cancer patients in the Pfizer drug Phase 2 and 3 clinical trials. She has a passion for personalized healthcare and works toward communication and conveying the importance of having companion diagnostics products that are beneficial to the patient. 16:25-16:55 Regulatory Overview on Companion Diagnostics Tracy Bush, Director and Global Coordinator of Companion Diagnostic Regulatory Affairs, Dr. Bush coordinates Roche s global regulatory strategy for companion diagnostics across all Roche Diagnostics business areas, including molecular and tissue diagnostics. She has over 10 years of experience in IVD regulatory affairs, with extensive submissions experience that encompasses a wide variety of assay platforms and technologies. She has negotiated the clearance of several 510(k) assays based on clinical data, and she also led the submission of the first human DNA-based genetic assay to gain FDA clearance. Prior to joining the regulatory group, as a member of Roche s Scientific Affairs team, she provided guidance to cardiologists and clinicians concerning the selection and interpretation of Roche s novel cardiac marker assays. She received a PhD in analytical chemistry from the University of Michigan and completed a post-doctoral fellowship in clinical chemistry at Washington University School of Medicine in St. Louis, Missouri. She is board certified in clinical chemistry and holds a regulatory affairs certification. 16:55-17:25 IVD Manufacturing GMP Requirement Jing Zhang, Regulatory Affairs and Government Affairs Director, Greater China, BD, is responsible for regulatory and government affairs in China, Taiwan and Hong Kong. MS. Zhang holds a MS in Bioengineering from Pennsylvania State University.She has over 20 years Regulatory and Quality experience in medical device industry (medical devices, IVD, capital equipment) and 3 years experience in biotech. Before this role, she was Director of Regulatory Affairs and Compliance in Nippon BD, held responsibilities for developing and implementing regulatory strategies, plans and policies for Nippon BD to meet business needs.ms. Zhang also worked in the US for over 15 years and has extensive experience in U.S. and EU device regulations and working knowledge of US and EU biologics/cell therapeutics regulations. 17:25-18:00 Basic Requirements for Registration Application of IHC Antibody Test Kit and Reagents Han Zhaozhao, Reviewer of Evaluation Division III of Center for Medical Device Evaluation, CFDA, Associate Professor, responsible for evaluation of clinical laboratory analytic instruments and reagents. She has been involved in compilation of Guide for Technical Evaluation of HBV DNA Reagents. 8:30-12:00,September 13 Co-Chair:Mr. Yang Zhen Deputy Director of Institute for Medical Devices Control of National Institutes for food and drug Control, graduated from TsingHua University of Peking 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 62 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. 21

5 Co-Chair:Mr. Hubert Bayer Head of APAC Regulatory Affairs for Roche Diagnostics. He holds a PhD in Biology (human and animal virology) from University of Freiburg. After 5 years as research scientist Hubert started at Roche Diagnostics in R&D in Global Regulatory Affairs responsibility started in 1996 for the Roche Professional Diagnostics. Since July 2013 the responsibility changed to APAC Regulatory Affairs for all Roche Diagnostics. Current functions at European IVD Manufacturer Association (EDMA) are member of the Regulatory Affairs Committee, Chair of IVD Technical Group and Member of the Globalization Task Force. 08:35-09:10 Establishment of IVD Reference Laboratory 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. 09:10-09:40 IVD Classification Dr. Hubert Bayer, Head of APAC Regulatory Affairs for Roche Diagnostics. He holds a PhD in Biology (human and animal virology) from University of Freiburg. After 5 years as research scientist Hubert started at Roche Diagnostics in R&D in Global Regulatory Affairs responsibility started in 1996 for the Roche Professional Diagnostics. Since July 2013 the responsibility changed to APAC Regulatory Affairs for all Roche Diagnostics. Current functions at European IVD Manufacturer Association (EDMA) are member of the Regulatory Affairs Committee, Chair of IVD Technical Group and Member of the Globalization Task Force. 09:40-10:10 PAL Administration in IVD Products and MHW s Latest Activities Yabuki Muneo, Senior Expert of Pharmacy Planning for Pharmacy Department, Sysmex Corporation, working on pharmacy affairs including registration of medical device and IVD reagent based on PAL and pharmacy regulations implementation of other countries. He is vice chair for JEITA, operation member for JACRI. He graduated from Facility of Engineering, University of Fukui with his major electric information. 10:10-10:20 Tea Break 10:20-10:50 The Key and Difficult Point of IVD Reagents Entering into Potential Korea Market Perry Zhao, Senior Regulatory technical manager of UL Health Science department, master, responsible for regulator consulting service, familiar with MFDS registration, FDA 510(k), software evaluation, risk management, clinical requirements, test standard for IVD device and reagent. 22

6 10:50-11:25 National Reference Material Management of Reagent for Clinical Diagnosis and Implementation of Related Metrology Plan Yang Zhen, Deputy Director of Institute for Medical Devices Control of National Institutes for food and drug Control, graduated from TsingHua University of Peking 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 62 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. 11:25-12:00 Basic Requirements for Registration Application of HBV DNA Reagent Lv Yunfeng, Reviewer of Evaluation Division III of Center for Medical Device Evaluation, CFDA, Ph.D, Associate Professor, responsible for evaluation of In-vitro diagnostic reagents and medical instruments. She has been involved in compilation of Guide for Technical Evaluation of HBV DNA Reagents. 23