In-vitro Diagnostic Devices Forum

Transcription

1 In-vitro Diagnostic Devices Forum 08:30-12:00, August 28 Co-Chair: Li Yaohua Deputy Director of Evaluation III Department of Center for Medical Device Technical Evaluation, CFDA. Co-Chair: Chen Yanhua Director of Regulatory Affairs and Compliance, BD. 08:30-08:35 Introductions of the Co-chairs 08:35-09:20 The Requirements for Registration Application of Drug Abuse Detection Reagents 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 and Guide for Technical Evaluations of Drug Abuse Diagnostic Test. 09:20-10:00 XXXXXX(TBD) 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. 10:00-10:15 Tea Break

2 10:15-10:50 FDA, CLSI, EUCAST and ISO: Challenges for Laboratories, Manufacturers, and Regulators with AST Systems. Brad Spring, Vice President of Regulatory Affairs and Compliance at BD Diagnostic Systems. He joined BD in 1999 and has responsibility for creating and executing global regulatory strategies, directing global product registration processes and ensuring regulatory compliance in the design, manufacture and distribution of a wide variety of IVD reagents, instruments and software. He has over 26 years of experience in the IVD industry, with 17 years of regulatory affairs experience. Prior to joining BD, he worked for Ortho Clinical Diagnostics (a Johnson & Johnson company) where he worked on PMA and 510(k) submissions, international product registrations, clinical trial designs, labeling, auditing, and regulatory compliance initiatives. He also has five years of experience in Program Management at BD; developing and launching new diagnostic platforms, and four years of sales experience in clinical laboratory instrumentation. Mr. Spring is active in several trade, scientific and standard development organizations including the Clinical Laboratory Standards Institute, Association of Molecular Pathology, the Association for the Advancement Medical Instrumentation, American Society of Microbiology, American Association for Clinical Chemistry, Regulatory Affairs Professional Society, and AdvaMed. He received his Bachelors of Science in Biology from Hobart College in Geneva, New York. 10:50-11:25 Diagnostics for Personalized Medicine - Critical Support Factors for Success Lubna Syed, RAC, B.Sc., Global Director of Regulatory Affairs at Janssen Inc., (a Johnson & Johnson company). In this capacity, she is responsible for the development of global regulatory strategy, policy, and registration of the in vitro diagnostic devices associated with product development and commercialization including companion and complementary diagnostics. She has been involved in submissions and approvals worldwide for numerous products. In 2013 alone, she obtained over 10 US FDA clearances and also received regulatory approvals from Australia, Canada, China, Japan, Singapore, Saudi Arabia, Taiwan, Turkey, and European Union. Her regulatory career has spanned both large and small companies and has included global programs, including China, Canada, US, Taiwan, Brazil, Mexico, Japan, and others. She received her university degree in Biochemistry from the University of Toronto and she has been involved with medical devices for over 22 years and in diagnostics for over 15 years and gained her experience working at Pall Biomedical, Visible Genetics, Bayer Healthcare (Diagnostics), Veridex (Johnson & Johnson) and Luminex (Molecular Diagnostics). 11:25-12:00 Supervisory Regulations and Detailed Implementing Rules after Listing in Europe Petra Kaars-Wiele, Senior Director International Regulatory, Quality & Labeling, Abbott GmbH & Co KG., Diploma and Ph.D. in Organic Chemistry, 31 years experience in Regulatory Affairs and Quality Systems for Medical Device, currently responsible for all international regulatory matters, medical event reporting, risk management, managing translation for 25 languages and labeling activities at Abbott Diagnostics Division. 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 Chairwoman of the EDMA Globalization Working Party dealing with new and revised worldwide regulations, 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, Convener of MDER III IVD working group, an initiative between the EU Commission and CFDA and Member of European Advisory Board of RAPS, member of the Association of Virology and the German Association of Blood Transfusion.

3 13:30-18:00, August 28 Co-Chair: 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. He is a member of national scientific and technological achievements appraisal committee,member of national medical apparatus and instruments of government purchasing audit committee,member of a committee that the national drug standard substance review. He 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. Besides he is Editor-in-Chief of the quality inspection and evaluation of medical devices work, won National Science & Technology Achievement Award for one time and Provincial Science &Technology Achievement Award for five times. As first inventor, he obtained for one national patent. 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. 13:30-13:35 Introductions of Co-Chairs 13:35-14:15 The Requirements on Application Material for the Registration of ToRCH Antibody and IgG Antibody Affinity Detection Reagents Han Zhaozhao, Reviewer of Evaluation Division III of Center for Medical Device Evaluation, CFDA, mainly engaged in the technical evaluation of in vitro diagnostic reagents and equipment, she is an assistant researcher. She has compiled The Guiding Principles of Technical Review of Affinity Detection Reagents for Toxoplasma, Rubella Virus, Cytomegalovirus, Herpes Simplex Virus Antibodies and Type G Immunoglobulin Antibody. 14:15-14:45 Implementation of GHTF Principles in Medical Device Regulations of Asian countries 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, he 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.

4 14:45-15:15 Introduction to Administrative Laws and Regulations and Technical Evaluation System of IVD in China YangZhen, 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. He is a member of national scientific and technological achievements appraisal committee,member of national medical apparatus and instruments of government purchasing audit committee,member of a committee that the national drug standard substance review. He 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. Besides he is Editor-in-Chief of the quality inspection and evaluation of medical devices work, won National Science & Technology Achievement Award for one time and Provincial Science &Technology Achievement Award for five times. As first inventor, he obtained for one national patent. 15:15-15:30 Tea Break 15:30-16:00 FDA Regulations and Implementation Stefanie Leschonsky,Manager Quality, Abbott GmbH & Co KG. She holds a degree as Diplom -Ingenieurin (FH) (graduate engineer) for Biotechnology from Mannheim University of Applied Science (Germany). She has 14 years of work experience in Quality, Product Operations, and R&D areas for Medical Devices. In her role as Manager Quality at ADD Wiesbaden she is responsible for leading the site quality function with approximately 80 employees. Her duties include quality oversight of CAPA, Change Control, Validation, Design Transfer and Logistics QA, applying various applicable regulatory standards, such as ISO 9001, ISO and 21 CFR Part 820. Stefanie further acts as the Management Representative for the ADD Wiesbaden site, representing the site for example during external inspections and during interactions with customers as well as regulatory authorities, such as US FDA. She holds a certificate for Quality Management from the Chartered Quality Institute (UK) and has experience in building Quality Management Systems according to ISO 9001 and ISO She completed her lead auditor training in During her career, she has applied her expertise for example during establishing departments for complaint handling, regulatory affairs and auditing at a new ADD facility in Longford / Ireland as well as during achieving first-time FDA certification for the ADD manufacturing facility in Wiesbaden / Germany. 16:00-16:30 Product Development and QRA Management in Innovative Flow Cytometry Instruments and Reagents Jeannine Holden, MD, Director of Scientific Affairs for Flow Cytometry at Beckman Coulter Inc. Prior to joining the Beckman Coulter team in 2013, she was Associate Professor and Director of Hematopathology& Flow Cytometryat Emory University School of Medicine in Atlanta, Georgia where she ran a busy reference laboratory providing expert consultation service in microscopy, flow cytometricimmunophenotyping, fluorescence in situ hybridization, cytogenetics, and molecular diagnostics. She is currently president of the International Clinical Cytometry Society, and is actively involved with both the International Society for the Advancement of Cytometry and the European Society for Clinical Cell Analysis. Her research interests are improved patient safety and quality care in the context of diagnosis and treatment of patients with leukemia and lymphoma.

5 16:30-17:00 Changes to the IVD Regulations in Europe Sun Yun, Scheme Manger and Technical Expert at British Standard Intuitions (BSI)where she is responsible for certification and technical file review for non-active devices to European Medical Device Directive 93/42/EEC and In Vitro Diagnostic Device Directive 98/79/EC. She holds a PhD Degree in Chemistry from UK, and was a research associate at University of Cambridge after her PhD. Prior to joining BSI, Dr Sun has been working in R&D in Johnson & Johnson for a number of years where she was responsible for projects from concept creation to launch and post-launch, especially on execution and sustaining.the device experience of Dr Sun includes the design, development and manufacture of artificial skin, blood purification system, neural implant and self-monitoring blood glucose system etc. 17:00-17:30 Requirements and Implementing Procedures of the Clinical Trials for IVD Zhu Yongqin, IVD Clinical Research Manager, Jyton-Kannel Medical Technology Co.,Ltd., with nearly 10 years of experience in clinical research of in vitro diagnostic reagents. 17:20-18:00 A Notified Body view of the new IVD Regulation Nick Baker, Technical Manager for Medical Devices at Lloyd's Register Quality Assurance (LRQA), with responsibility for conformity assessment activities and certification under the In-Vitro Diagnostics Medical Devices Directive. Prior to this, he was at the British Standards Institute where he was a scheme manager responsible for applying for designation as a Notified Body under the IVD Directive and the conformity assessment activities of ocular devices under the Medical Devices directive. He is a member of the IVD working group for Notified Bodies and the MHRA External Strategy Group for the IVD Revision. Nick has previously worked in the in-vitro diagnostics industry, including Wellcome Diagnostics (later Murex Diagnostics) with experience and in the design and production of immunoassays for infectious diseases. He started his career in clinical chemistry laboratories in the National Health Service and is a Fellow of the Institute of Biomedical Sciences. 08:30-12:00, August 29 Co-Chair: Li Yaohua Deputy Director of Evaluation III Department of Center for Medical Device Technical Evaluation, CFDA. Co-Chair: Tim Krauskopf Vice President of Regulatory Affairs for the CAI business unit of Siemens Healthcare Diagnostics. Joining Siemens in 2013 and based in Tarrytown, New York, USA, he leads a team of regulatory exports in achieving governmental authorizations around the world for the sale of over 3000 distinct IVD products, including instruments, reagents, software, automation and IT products and services. He has 30 years of experience with medical device and IVDs, and held the senior executive Regulatory, Quality and Clinical position at various medical device and IVD companies including Bayer HealthCare, Datascope Inc., and Cytyc Corporation. He received regulatory affairs certification from RAPS initially in 1992; formerly served as a member of the Board of Directors of MassMEDIC, and was the designated Board representative of the AdvaMed Technology and Regulation committee for Bayer Medical Care.

6 08:30-08:35 Introductions of Co-Chairs 08:35-09:20 Analysis of Performance Requirements for Genetic Mutation Detection Reagents Li Yaohua, Deputy Director of Evaluation III Department of Center for Medical Device Technical Evaluation, CFDA. 09:20-09:55 Related Control on Clinical Trial of IVD Products and Responding Situation in Japan Yabuki Muneo, Senior Expert, Sysmex Corporation of pharmacy department. He graduated from the Faculty of engineering, University of fukui. He entered Sysmex Corporation in Since 1985, he engaged in the development of medical devices and in vitro diagnostics to the Japanese pharmaceutical affairs law based registration business and coping with the national regulations for 29 years. In 2005, he served as vice chairman of the Committee of experts of JEITA ME. Since 2006, He is in charge of clinical examination Medicine Association Rules Committee operations committee. 09:55-10:30 Global Regulatory Trend for IVD Risk Assessment Christina Yang, Vice President, Global Regulatory Affairs of the Diagnostics business, Beckman. She brings over twenty years experience in regulatory and clinical affairs, quality assurance, quality engineering and quality control. Previously, she served as Senior Vice President, Regulatory Affairs and Quality of Hologic/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, she 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. 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. Dr. Yang is a Regulatory Affairs Certified (RAC), an ISO9000 certified lead auditor and a Certified Quality Auditor (CQA). Dr. Yang has been invited as the speaker in numerous international Regulatory Conferences. 10:30-10:45 Tea Break 10:45-11:20 Risk Analysis of IVD Products Tim Krauskopf, Vice President of Regulatory Affairs for the CAI business unit of Siemens Healthcare Diagnostics. Joining Siemens in 2013 and based in Tarrytown, New York, USA, he leads a team of regulatory exports in achieving governmental authorizations around the world for the sale of over 3000 distinct IVD products, including instruments, reagents, software, automation and IT products and services. He has 30 years of experience with medical device and IVDs, and held the senior executive Regulatory, Quality and Clinical position at various medical device and IVD companies including Bayer HealthCare, Datascope Inc., and Cytyc Corporation. He received regulatory affairs certification from RAPS initially in 1992; formerly served as a member of the Board of Directors of MassMEDIC, and was the designated Board representative of the AdvaMed Technology and Regulation committee for Bayer Medical Care.

7 11:20-12:00 Analysis of Main Review Points on Human Infection with Avian Influenza A (H7N9) Virus Detection Reagents Wu Kun, Reviewer of Evaluation Division III of Center for Medical Device Evaluation, CFDA. He is an engineer, mainly engaged in the technical review of in vitro diagnostic reagents and equipment. He has compiled The Guiding Principles of Application Dossiers for Registration of Influenza Virus Antigen Detection Reagents, responsible for the compilation of The Main Review Points in on Human Infection with Avian Influenza A (H7N9) Virus Detection Reagents.