In-vitro Diagnostic Devices Forum

In-vitro Diagnostic Devices Forum08:30-12:00, 9 月 6 日 08:30-12:00 September 6Co-Chair: Ms. An JuanjuanDirector of Division III of Evaluation, Center for Medical Device Evaluation, SFDA.Co-Chair:Jesús Rueda RodríguezRegulatory Affairs Director for the European Diagnostics Manufacturer’s Association (EMDA),responsible for the coordination of industry position and responses in the process of revision andrecast of the IVD Directive, Member of the European Commission Medical Devices Expert Group andseveral key subgroups, including the IVD Technical Group. He focuses on the furthering of interestsof EDMA member companies, relative affairs at GHTF, WHO and other international standardizationbodies such as ISO and CEN.08:30-09:20 Clinical Trial for Combination IVD with Drug (Remote Speech)Sally Hojvat09:20-10:05 Key Points about Technical Review of Influenza Virus ReagentsWu Kun, Reviewer of Division III of Evaluation, Center for Medical Device Evaluation, SFDA.10:05-10:20 Tea Break10:20-11:05 Introduction of Revised EU 98/79 DirectiveJesús Rueda Rodríguez, Regulatory Affairs Director for the European Diagnostics Manufacturer’sAssociation (EMDA), responsible for the coordination of industry position and responses in theprocess of revision and recast of the IVD Directive, Member of the European Commission MedicalDevices Expert Group and several key subgroups, including the IVD Technical Group. He focuseson the furthering of interests of EDMA member companies, relative affairs at GHTF, WHO and otherinternational standardization bodies such as ISO and CEN.60

14:50-15:25 European Reference Material and Traceability ManagementDr. 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 departmentsat affiliated hospital of Philipps-University Marburg and DRK Hospital. After two years experience asa physician assistant in Laboratory medicine of University Central Lab, he worked for BIOSCIENTIAGmbH as the head of Immunology Department. He joined in Abbott Diagnostics Division in 2005 asthe Associate Medical Director in international operations department.15:25-16:00 IVD National Reference Material and High Risk Standard ManagementYang Zhen, Deputy Director of Institute for Medical Devices Control of National Institutes for food anddrug Control, graduated from TsingHua University of Peking Union Medical College with microbiologyand biochemical medicine PhD degree, Chief Pharmacist. He has participated in the key projectsof national Eight-five-year plan to national Eleven-five-year plan, managed two of the key projectsof national” 863 “and “973”plan and issued 32 articles on SCI or National Core Journal as thefirst author. He is the Editor-in-Chief of The Quality Inspection and Evaluation of Medical Deviceswork 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 Break16:15-16:50 IVD Trend in AACCCong Yulong, Civil General, Director for Army Medical Laboratory Sciences and Quality ControlCenter, Chief Physician, Professor, Doctoral Supervisor. He is a member of Health Care ExpertsGroup for Chinese PLA General Hospital and enjoys the special government allowance by theState Council. Mr. Cong Yulong is appointed as Chairman of the 4th National Medical Lab and IVDStandard Committee, Chairman of the 2nd Medical Technology Sub-committee, Certification andAccreditation Administration of the People’s Republic of China, Chairman of the 7th PLA LaboratoryMedicine Committee, Chairman of the 7th PLA Medical Standard Substance Committee, Chairman ofthe 2nd Laboratory Physician Branch of Chinese Medical Doctor Association, the 6th Chief Editor forChinese Journal of Laboratory Medicine. He was once served as a member of the 2nd, a StandingCommittee member of the 3rd, Vice Chairman of the 4th, Chairman of the 5th and 6th and 7th ofLaboratory Science Branch of Chinese Medical Association. He won many Scientific and TechnologicProgress Awards, Excellent Teacher, Medical Education Award. He made 260 papers, of which 23 asthe 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 nationalspecial doctor training Laboratory Medicine.16:50-17:25 OEM products”: Impact on Product Registration and Regulatory Complianceof IVD manufacturersDr. Hubert Bayer, Director of Global Regulatory Affairs at Roche Diagnostics, PhD in Biology/Humanand Animal Virology. He used to work as a research scientist at University of Freiburg for RetrovirusResearch and at German Primate Center for HIV research. He is a member of Regulatory AffairsCommittee 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 KitMs. Chen Tingting, Reviewer of Division III of Evaluation, Center for Medical Device Evaluation,SFDA.62

10:30-11:00 XXXMr. Wang Jiankang, Technical Secretary of Drug Clinical Trial Institute of the General Hospital ofthe Air Force, Pharmacist-in-charge. With a long time experience in clinical evaluation of drug andmedical device, he made clinical evaluations of 80 medical devices and 100 IVD reagents. Heparticipated in 100 Phase II-IV drug clinical trials. As the main research fellow, he finished 10 Phase Iclinical trials. He has published 40 papers.11:00-11:30 IVD Packaging and Labeling AdministrationDr. Petra Kaars-Wiele, Senior Director of International Regulatory Affairs/ Packaging and LabelingAdministration, Abbott GmbH & Co KG, responsible for all international regulatory affairs, medicalevent reporting, translations for packaging and labeling in 25 languages and labeling managment atAbbott Diagnostics Division, Ph.D. of Organic Chemistry. She has more than 29 years experiencein international regulatory affairs and quality systems for medical device. She is the Chair ofEDMA Globalization Task Force; Member of EDMA Regulatory Committee and Technical Forum;Representative of GHTF SG1, IVD Subgroup, EDMA from 2003 to 2012; Member of InternationalTask Force and Blood Safety Working Party of EUCOMED; Member of European Advisory Board ofRAPS, 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 andSuggestions for ThemMr.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 Invitro diagnostic medical device, and has extensive knowledge of the registration procedures andrequirments of China,CE,FDA ,Canada and other markets.64