Medical Device Clinical Trial Forum

Transcription

1 Medical Device Clinical Trial Forum 08:30-12:00, August 28 Co-Chair: Feng Xiaoming Research Fellow of China Food and Drug Testing Institute, Deputy Director of Biomaterial and Tissue Engineering Lab, working on safety evaluation and testing of biomaterial and tissue engineering as well as analytical instruments application in biomaterial field. He is standing director of analytic instruments branch, China Instrument and Control Society, deputy director of Chinese Society of Medical Biomedical Engineering, evaluation expert of medical device registration, CFDA, GMP auditor, accreditation reviewer of medical device testing lab, China National Accreditation Board For Laboratories. He undertakes as members for many academic journals. Co-Chair: Carol Yan Vice President of Regulatory Affairs in Johnson & Johnson Medical China, with responsibilities of JJMC regulatory affairs management as well as providing regulatory strategies to the China NBD and Johnson & Johnson Asia Pacific R&D functions to drive business growth. She also serves as member of the J&J Medical China Management Board. She is actively involved in shaping regulatory environment in both China and the Asia Pacific Region. From 2012 until now, she holds the various leading positions in EUCCC and AmCham China. In the meantime, she holds co-chair position of Special Task Group in AHWP (Asia Harmonization Working Party) to drive regulation harmonization in ASPAC region since She received her Bachelor s degree in clinical medicine from Capital University of Medical Science and MBA from Rutgers Business School, State University of New Jersey. 08:30-08:35 Introduction of the Co-Chairs 08:35-09:15 Medical Device Clinical Trials Under New Laws and Regulations Wu Aijun, Director of Research and Evaluation Division of Medical Device Supervision Department, CFDA. He once served as the Head of the General Affairs Division of Center for Medical Device Evaluation, SFDA. 09:15-09:45 Clinical Evaluation Systematic Literature Review Kathy Harris, Worldwide Vice President, Regulatory Affairs for DePuy Synthes Joint Reconstruction, a Johnson & Johnson Company, with over 35 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. Kathy holds a bachelor's degree in Chemistry and a Masters of Business Administration. She holds certifications in Regulatory Affairs, Quality Engineering and Quality Auditing. 9

2 09:45-10:15 Clinical Trial and Clinical Evidence Requirement for Device Approvals in US FDA Zhang Mingdong, Chief Medical Officer, Boston Scientific China. He worked as Assistant Professor of Epidemiology, Medical Officer/Epidemiologist, US FDA, Chinese University of Hong Kong, Special Volunteer (Adjunct Investigator), Viral Epidemiology Branch, Division of Cancer Epidemiology and Genetics, NCI, NIH. He got Ph.D. at Molecular Virology in Baylor College of Medicine and published more than forty research articles internationally. 10:15-10:30 Tea Break 10:30-11:00 The Statistical Considerations for Single-Arm Objective Performance Criteria Medical Device Clinical Trials Li Wei, Director of Medical Research & Biometrics Center, National Center for Cardiovascular Diseases, Visiting Professor of the Chinese University of Hong Kong, External Advisor of CFDA for Drug & Medical Device Clinical Trial, External Advisor of National Science & Technology Commission, Member of the American Statistical Association (ASA), Member of the Drug Information Association (DIA), Member of the American Clinical Trial Association, Member of the China Clinical Trials Statistics Working Group (CCTS). 11:00-11:30 Statistical Design of Clinical Trials Jennifer Mischke, Director of Biostatistics and Data Management for NAMSA, responsible for a team of statisticians, data managers, database developers, and trial administrators which handles all aspects of database design, data and file management as well as statistical aspects of the design, execution, and analyses of clinical studies. She has authored numerous regulatory submissions, manuscripts, presentations, marketing materials, and other publications, with a focus on statistics and scientific considerations. With 15 years working in clinical research, Jennifer's background includes experience on all phases of clinical studies, including pre-clinical, clinical, post-market, shelf-life for drug/device combination products, and in vitro diagnostics. She is also adjunct faculty at St. Cloud State University, instructing Masters-level biostatistics courses. She earned her M.P.H in epidemiology with a concentration in biostatistics from the University of Minnesota, and her B.A. in applied mathematics from Augsburg College. 11:30-12:00 The Differences Between Medical Device and Pharmaceutical Clinical Investigations Danielle Giroud, MBA, Founder, WMDO & MD-CLINICALS. With over 25 years of experience, she is founder and senior faculty board member of the World Medical Device Organization (WMDO). She also founded MD-CLINICALS, a 100% medical device dedicated Clinical Research Organisation with main activities in the Asia Pacific, South American, European and Middle East countries. She is regarded as a recognized clinical research and regulatory expert within the medical device industry, having shared her extensive knowledge and experience with multi-national corporations and startup companies from around the globe. She is also currently convener for the expert group on clinical investigations; TC 194 WG4 for the ISO14155 as well as liaison with the EU Commission-CIE (Clinical Investigation and Evaluation) task force. 10

3 13:30-18:00, August 28 Co-Chair: Xu Wei Director of Center for Medical Device Evaluation, CFDA, 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: Glen Sabin Regulatory Affairs Director at GE Healthcare, responsible for global regulatory submissions associated with GE Healthcare's magnetic resonance imaging devices. With over 14 years of experience in the medical device industry, he is MR Section Chair of the Medical Imaging &Technology Alliance (MITA), and a member of the IEC committee responsible for maintaining MR safety and performance standards. 13:30-13:35 Introduction of the Co-Chairs 13:35-14:05 A Latest Update Concerning the ISO Standard on Medical Device Clinical Investigations in Humans Danielle Giroud, MBA, Founder, WMDO & MD-CLINICALS. With over 25 years of experience, she is founder and senior faculty board member of the World Medical Device Organization (WMDO). She also founded MD-CLINICALS, a 100% medical device dedicated Clinical Research Organisation with main activities in the Asia Pacific, South American, European and Middle East countries. She is regarded as a recognized clinical research and regulatory expert within the medical device industry, having shared her extensive knowledge and experience with multi-national corporations and startup companies from around the globe. She is also currently convener for the expert group on clinical investigations; TC 194 WG4 for the ISO14155 as well as liaison with the EU Commission-CIE (Clinical Investigation and Evaluation) task force. 14:05-14:35 Fracture Treatment Concept and Clinical Performance for Far Cortical Locking Device Kwan Han Ong, MHSM, BSc., Associate Director Clinical Research, Clinical Affairs, Asia-Pacific Region, Zimmer. With more than 18 years of experience in clinical research in the Asia-Pacific region, he has held numerous portfolios in his endeavor in multinational pharmaceutical and medical device companies. 11

4 14:35-15:05 Clinical Expert Report (CER) to Prove Safety and Efficacy Instead of a Clinical Trial Jonathan Batiller, Director of Clinical Development for ETHICON, responsible for the global clinical development organization within the Biosurgery and Energy business platforms for Johnson &Johnson Global Surgery Group of companies. These business units develop class II and III devices, including Biologic-device combination products for use during surgery. He has been with Johnson & Johnson for the past 14 years with growing responsibilities within Clinical Development in various companies involving product development including products for interventional cardiology, cardiovascular surgery, general surgery, plastic/reconstructive surgery and women's health & Urology, among others. Jonathan graduated from Fairleigh Dickinson University with a BS in Biomedical Technology, attended the University of Medicine and Dentistry of New Jersey, and also has an MBA in Pharmaceutical Management from Silberman College of Business. 15:05-15:35 Supervision of Medical Device Clinical Trials at Hospital Level Wang Jiankang, Technical Secretary of Drug Clinical Trial Institute of the General Hospital of the Air Force, Pharmacist-in-charge. He holds a Medicine Master degree. 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. Mr. Wang 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. 15:35-15:50 Tea Break 15:50-16:20 Mapping Your Succcess - Understanding Clinical Equivalence Gert W. Bos, Head of Regulatory and Clinical Affairs at BSI Healthcare (NB0086 / NB0535) and Head of Notified Body at BSI-Germany (NB0535).He earned his PhD at Twente University of Technology, Enschede, the Netherlands. He has 21 years of experience in lifesciences (devices and pharma), in university, industry as well as in four Notified Bodies. He is president of the Notified Body association TEAM-NB, vice-chair of the Medical Notified Body forum NB-Med in Brussels, and participates in the Notified Body Recommendation group (NBRG), the Clinical Investigation and Evaluation Group (CIE), Medical Device Expert Group (MDEG) and the MDEG workgroups on animal tissue, on MRA's, e-labeling, EUDAMED and on IVD's. He is one of the Regulators representing Europe in the IMDRF Workgroup on regulated Product Submissions. He is a member of the board of the Dutch RA Chapter. 16:20-16:50 Case Analysis of Common Problems in Clinical Research During Registration Yu Hong, Manager of Clinical Research of Jyton-Gowin Medical Technology Co., Ltd., mainly responsible for registration and post-market researches of domestic and overseas medical device clinical trials and has almost 10 years experience in drug and medical device clinical trials. She is involved in clinical trials in fields including orthopaedics, cardiovasology, stomatology, medical imaging, dialysis, diagnostic equipment, reagents, laser, ultrasound and polymer consumable products. She is in longstanding cooperation with more than 30-plus research units in China and is familiar with operational process and requirements of clinical trials in hospitals. 16:50-17:20 Substantial Equivalence for 510(k): MR Practice Glen Sabin,Regulatory Affairs Director at GE Healthcare, responsible for global regulatory submissions associated with GE Healthcare's magnetic resonance imaging devices. With over 14 years of experience in the medical device industry, he is MR Section Chair of the Medical Imaging &Technology Alliance (MITA), and a member of the IEC committee responsible for maintaining MR safety and performance standards. 12

5 17:20-18:00 A Brief Discussion of Technical Requirements for Patient Monitor and Technical Review Requirements for Clinical Assessment Zhang Song,Reviewer of Evaluation Division I of Center for Medical Device Evaluation, responsible for technical review of medical electrical equipment. He holds a master degree. 08:30-12:00, August 29 Co-Chair: Lan Wengchi Office Deputy Director of Center for Medical Device Evaluation, CFDA. She once served as a member of Preparation Team of Medical Device Standard Committee, SFDA holding responsibility for national standard and industry standard of non-active medical devices. Co-Chair: Keith Proctor Corporate Vice President of Regulatory and Clinical Affairs, Zimmer Inc. with many decades of medical device experience. He has several patents, published papers, medical device approvals in all regions of the world. He has been employed by large multinational corporations and also small startup enterprises. His current responsibilities are to lead the world wide regulatory and clinical affairs organizations for Zimmer. 08:30-08:35 Introduction of the Co-Chairs 08:35-09:25 Concerns about Artificial Arthroplasty Clinical Trials and Product Review Zhang Jiazhen, Reviewer of Evaluation Division II of Center for Medical Device Evaluation, CFDA, Master of Material Processing Engineering, mainly responsible for technical review of non-active orthopedic implants and surgical instruments. He has been involved in compilation of Guidelines for Technical Review of Hip Joint Arthroplasty System Registration and formulation of many standards including Neurosurgical Implants, Preformed Skull Plate and Implant for Surgery-Skeletal Pins-Part 2:Kerning Needle Size. 09:25-10:00 Managing Global Medical Device Clinical Trials Linda S. Alexander, Clinical and Consulting Vice President of Global Market,NAMSA. She founded Alquest, a dedicated medical device CRO, in 1993 with a vision to providing comprehensive, integrated services to device manufacturers. 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. Ms. Alexander has a B.S. in Biology from Iowa State University and M.S. in Technical Communications from the University of Minnesota. 13

6 10:00-10:15 Tea Break 10:15-10:50 Clinical Trials Design of Joint Product and Comparative Analysis of Clinical Practices Lin Jianhao, Director of Joint Disease Diagnosis and Treatment Research Center of Peking University People's Hospital Chief Physician, Professor, Doctoral Supervisor. He obtained his bachelor's degree of medicine at Zhejiang Medical University and doctor's degree of surgery at Peking University Health Science Center. Mr. Lin is engaged in surgical treatment of various arthritis, especially the orthopedics of arthritis occurs in lower limbs i.e. hip joint, knees and ankles. His major research fields include: comprehensive treatment and prevention of common osteoarthritis happening to aged people; pathogenesis analysis of osteoarthritis. He was in listed among the first batch of health science experts of Beijing (2011~2013) and serves as vice chairman of the Spinal Joint Disease Special Committee of Gerontological Society of China (2011~), associate editor of Chinese Journal of Joint Surgery (2012~2016), executive member of the Osteoarthritis Research Society International (OARSI)( ), committee member of Joint Surgery Group of the Chinese Orthopaedic Association, editorial board member of HSS Journal, editorial board member of BMC Musculoskeletal Disorders, etc.. 10:50-11:25 Practice on Clinical Research Management Xu Yimin, Senior Vice President of Regulatory Affairs of Shanghai MicroPort Medical (Group) Co., Ltd. and a member of CEC. He was Vice President of Quality and Regulatory of Shanghai MicroPort Medical (Group) Co., Ltd until Jan He has over 14 years of experience in medical device industry. Prior to joining MicroPort, he served as project manager in Project Department of Shanghai Zhangjiang Hi-Tech Development Co., Ltd.. 11:25-12:00 Common Challenges for IVD Clinical Trials: An Infectious Diseases Perspective Tobi B. Karchmer, MD, MS, Vice President of Corporate Clinical Development for BD, responsible for the design and execution of clinical trials to support evidence generation for new products for BD. She joined BD in 2007 as a Medical Director for BD Diagnostics and became VP, Medical Affairs for BD Diagnostics in She received her medical degree from Harvard Medical School and Master of Science from the University of Virginia. She is a fellow of the Society for Healthcare Epidemiology of America (SHEA) and a member of the Infectious Diseases Society of America (IDSA) as well as an Associate of the American College of Physicians. She served on the Board (Academic Councilor) of SHEA, , and has served on various committees and task forces of SHEA and IDSA. 14