Medical Device Innovation Forum 08:30-12:00, September 12 Co-Chair: Guo Xiaolei Reviewer of Evaluation Division ll of Center for Medical Device Evaluation, CFDA, is primarily responsible for technical evaluation of non-active orthopaedic implants.
Co-Chair: Lynn Pawelski Johnson & Johnson
08:30-08:35 Introduction of the Co-Chairs
08:35-09:15 Overview the Performance of International Medical Device Regulatory Forum (IMDRF) Wang Lanming, Deputy Director-General (Director-General level), Department of Medical Device Registration, China Food and Drug Administration (CFDA). Professor, M.Sc., MPA. Vice-chair of the Advisory Committee, Chinese Society of Biomedical Engineering (CSBME); Member (representative of CFDA) of the Management Committee, International Medical Device Regulators Forum (IMDRF). He once worked in university and research institute, and then joined the SDA/ SFDA/CFDA in the field of medical device. He ever served as Director-General of the Department of Medical Device Supervision in SFDA, and Director-General of the Department of Medical Device Registration in CFDA.
09:15-09:45 Innovative Medical Devices and Global Universal Healthcare Markets: Asscess and Value Eugene Salole, Principal at Value-Based Access P/L, an independent Sydney-based healthcare consultancy, which develops evidence-based value propositions for innovative medical devices and diagnostics in support of premium pricing, reimbursement, funding and market access strategies for the Australian and major Asia-Pacific markets. Previous experience includes senior Market Access roles in global medical device and pharmaceutical companies, and pro bono consultancy for the WHO Essential Drugs Programme in sub-Saharan Africa, advisory work for the Departments of Health in Canada, Nigeria, Taiwan and Britain. Regularly contributes to the peer-reviewed literature on the value of innovative healthcare technology. Serve as Conjoint Associate Professor in the Faculty of Medicine, University of New South Wales, Sydney, Australia.
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09:45-10:15 Reuse and Reprocessing Considerations in Medical Device Development David Locke, Senior Regulatory Program Lead for Johnson and Johnson (Ethicon) which is located in Blue Ash, Ohio.Dr. Locke's background includes over twenty years of combined experience in medical device development, drug development, clinical medicine and surgery. He is also an adjunct instructor for Johns Hopkins University. His professional and research interests include medical device regulations, reprocessing of single-use devices, regulatory training, medical device intellectual property and antisense technology. Dr. Locke received his Bachelor of Science degree in Biology from Wright State University, his Master of Science degree in Bioscience Regulatory Affairs from Johns Hopkins University and his Doctorate Degree in Regulatory Science from the University of Southern California.
10:15-10:30 Tea Break
10:30-11:00 Fostering a Regulatory Framework that Encourages Innovation William Lee, Senior Director, Regulatory Affairs, Greater Asia, has more than 25 years of pharmaceutical and healthcare industry experiences in the areas of manufacturing, quality compliance, medical information, regulatory due diligence, clinical development and regulatory affairs in both local and regional roles in large and medium sized pharma, medical devices and biologics companies. He has deep experiences in drugs and device development and regulatory affairs across many therapeutic areas, drug modalities and medical devices. William has developed and formulated regulatory strategies for key strategic products that resulted in successful approvals and launches across Asia Pacific and Greater Asia. A licensed pharmacist, William obtained his MBA from the University of Strathclyde, UK and B.Sc. (Pharmacy) Honors from the National University of Singapore.
11:00-11:30 Advance in Research and Development of Full-degradable DES Xi Tingfei, Director of Tissue Engineering Center of Beijing University, Director of Biomedical Material and Tissue Engineering Center of Beijing University in Shenzhen, Researcher, Ph.D Supervisor, Master of Medicine at Beijing Medical School. He used to be 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 over 200 articles. He also participated in compiling 16 booksas the chief editor or editor and 15 national or industrial standards.
11:30-12:00 EU Medical Device Regulation on SUD Peter Schroeer, Senior Director, Regulatory Policy Innovation, Johnson& Johnson Medical Devices. He is responsible for ensuring global regulatory policies are appropriately interpreted, effectively communicated and efficiently implemented in the Johnson & Johnson Medical Devices companies. He worked in the medical device industry for over 20 years leading manufacturing, quality and regulatory affairs teams. Peter Schroeer does have broad experience in EU and Europe Middle East Africa product approvals and is a member of various Eucomed Working groups and is the chair of the Eucomed Reuse Task force. He received is Diploma (Dipl. Ing. ) in Chemical Engineering from the University of Muenster, Germany.
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13:30-18:00, September 12 Co-Chair: Jia Jianxiong Comprehensive Business Division of Center for Medical Device Evaluation, CFDA.
Co-Chair: Joyce Wang As the VP of Quality and Regulatory Affairs, Medtronic Greater China to drive and sustain functional excellence in the areas of Quality and Regulatory Affairs, contribute to the development and execution of the overall strategic plan and the associated business imperatives for future growth and success. Joyce spent most of her career at Baxter Healthcare China, mainly in manufacturing, operation, quality and regulatory compliance. She has been with this industry for around 20 years.
13:30-13:35 Introduction of the Co-Chairs 13:35-14:10 Introduction of Special Review and Approval in Innovation Medical Devices Regulations Jia Jianxiong, Comprehensive Business Division of Center for Medical Device Evaluation, CFDA.
14:10-14:40 Need for Innovative Device Regulations Priya Jagasia, Director, Regulatory Affairs of Abbott Vascular. She has extensive experience in regulatory affairs for both drugs and devices. She has managed the regulatory strategy for multiple device applications for both DES and BVS applications in US, Canada and other geographies. Most recently, she was part of the BVS panel prep team in the US. She is also part of the AdvaMed working group for combination products. Priya holds a Master’s degree in Analytical Chemistry from Mississippi State University in the US.
14:40-15:10 3D Printing Application in Orthopaedics Zion Xu, Zimmer Biomet medical holding AsPac R&D centre director. He is responsible for all innovation activities in Asian Pacific region, including understand customer needs in emerging marketing, find technical solution and commercialize with respect to regulatory requirements. He and his team recently dedicate in developing Chinese patient specific orthopaedic implants. he was engaged in R&D after graduated from CAU, worked in several top orthopaedic companies to develop reconstructive and trauma implants for more than 12 years. He is also the member of China implant technical standard committee.
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15:10-15:40 Innovation through Regulatory Policy Reform-How You Can Contribute Susumu Nozawa, RAPS Board Member; Director, Regulatory and Technical Policy at Corporate Regulatory Affairs, BD. He is responsible for establishing and implementing a global technical and regulatory policy management program within BD, which program monitors and influences technical standards and regulatory policy developments through standards developing organizations and trade organizations in order to realize and maintain BD' s market access worldwide. He also publishes periodic policy reports to communicate significant and actionable policy information to the senior management. In his career, he has held various positions in R&D, Regulatory Affairs and Compliance, and Quality Assurance for global operation. Immediately before joining BD, he was the Chief Operating Officer of a California-based medical device company, specializing in development of objective retinal function analyzers. He is a Board Member of RAPS and holds RAC (US&EU). As a Director, he led the publication projects of Fundamentals of Japanese Regulatory Affairs (First Edition in both Japanese and English) and Terms and Definitions of Japanese Regulatory Affairs (a bilingual edition) as the Editor in-Chief, and is currently working on revising the publications to further demystify the Japanese Regulatory System. 15:40-15:50 Tea Break 15:50-16:20 FDA Regulations for Innovative Medical Devices Kristy Katzenmeyer-Pleuss, Ph.D. Senior Medical Research Manager for NAMSA, a medical device CRO providing full-service support throughout the product development process. Kristy was previously based in the U.S. with NAMSA's regulatory team and is currently based in Berlin, Germany with NAMSA's EU regulatory, quality, validation, and biosafety team. Kristy's role is to help clients with U.S. regulatory strategy, premarket submissions and responses to additional information requests, global regulatory research, developing and reviewing protocols and reports for reprocessing and sterilization validations, and preparing biological risk assessments. Kristy is a former U.S. FDA lead medical device reviewer; her experience includes premarket submissions for a variety of device types, including general surgical, dermatologic, cardiovascular, peripheral venous, oncologic, orthopedic, and aesthetic devices. While at the FDA, Kristy also served as a subject matter expert in the areas of biocompatibility, reprocessing (reusable and reprocessed single-use devices), and sterilization. She was actively involved in medical device policy development, including drafting Guidance documents, new classification regulations, and proposed Orders/Rules. Kristy also participated in manufacturing site inspections to provide scientific/technical support to FDA’s district and national field officers. Kristy holds a Ph.D. in Bioengineering from the University of Washington and a B.S. in Chemical Engineering from the University of Wisconsin-Madison. 16:20-16:45 3D Printing Regulation and Custom Made Products Regulation Update in US/EU Sharon Starowicz, Director of Regulatory Policy Innovation, Global Orthopaedics, for Johnson & Johnson, where she is responsible for providing strategic regulatory guidance and expertise and, with a focus on the external environment, shaping the evolving regulatory policies that impact our industry. Sharon holds a BS degree in Engineering Science and Mechanics and an MS degree in Engineering Mechanics from Virginia Polytechnic Institute and State University (Virginia Tech). Sharon currently serves as the President of the Orthopedic Surgical Manufacturers Association (OSMA), an industry trade organization whose membership consists of manufacturers of orthobiologics, orthopedic and spinal devices, who work with FDA and other regulatory agencies and health care professionals on issues that lessen the regulatory burden and improve the application of device law. Sharon has over 30 years of regulatory affairs experience, specializing in Class I, II and III orthopedic and spinal devices. She has worked for Johnson and Johnson for over 19 years in 3 operating companies, having previously been a member of the Indigo Medical, Inc. management board with responsibilities for regulatory affairs, clinical affairs and quality systems, and having regulatory affairs and regulatory compliance responsibilities for DePuy Orthopaedics, Inc. prior to joining DePuy Spine, Inc. in 2004.
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16:45-17:10 Accelerating Access to Medical Device Technology: Innovative Approaches of the US FDA Pat Shrader, Vice President of Global Regulatory Affairs Medtronic. In this role, Pat leads the Regulatory Affairs function for the company, developing and implementing a regulatory strategy designed to meet Medtronic's overall short and long-term business goals and objectives. She serves as the primary company representative interacting with regulatory authorities across the globe to proactively influence regulatory policy and to respond to regulatory issues. She leads the Corporate Regulatory Affairs department and the global regulatory affairs leadership council. Prior to joining the corporate staff at BD, Pat led the Regulatory Affairs team for BD's Diagnostic Systems business. Before joining BD, Pat was an attorney with the Washington, DC firm Hogan &Hartson as a member of the FDA Practice Group. Pat was a founder of the In Vitro Diagnostics Roundtable, an FDA and industry group. She participates in the Advanced Medical Technologies Association as co-chair of the Technology and Regulatory Working Group, is Regulatory Affairs Certified and is a board member of the Food and Drug Law Institute. Pat is a graduate of Georgetown University Law Center and is a member of the bars of Pennsylvania, Maryland, and the District of Columbia.
17:10-17:35 Standards Development Process and Importance of Harmonized Approach Susumu Nozawa, RAPS Board Member; Director, Regulatory and Technical Policy at Corporate Regulatory Affairs, BD. He is responsible for establishing and implementing a global technical and regulatory policy management program within BD, which program monitors and influences technical standards and regulatory policy developments through standards developing organizations and trade organizations in order to realize and maintain BD' s market access worldwide. He also publishes periodic policy reports to communicate significant and actionable policy information to the senior management. In his career, he has held various positions in R&D, Regulatory Affairs and Compliance, and Quality Assurance for global operation. Immediately before joining BD, he was the Chief Operating Officer of a California-based medical device company, specializing in development of objective retinal function analyzers. He is a Board Member of RAPS and holds RAC (US&EU). As a Director, he led the publication projects of Fundamentals of Japanese Regulatory Affairs (First Edition in both Japanese and English) and Terms and Definitions of Japanese Regulatory Affairs (a bilingual edition) as the Editor in-Chief, and is currently working on revising the publications to further demystify the Japanese Regulatory System.
17:35-18:00 Inventive Intraocular Lens Designs to Accommodate the Life Styles of Patients in the New Millennium Liu Yueai, Ph.D.Principal Scientist and Assistant Director in Optical Design of Intraocular Lenses at Alcon, a Novartis Company. She has more than 15 years' design and development experience with ophthalmic optics specializing in the refractive and diffractive optic design of intraocular lenses, optical design of progressive addition spectacle lenses, and optical metrology of ophthalmic lenses. Many of her inventions have been patented. Dr. Liu gained her B.Eng. Degree from Changchun College of Optics and Fine Mechanics, her M.Sc. Degree from the Institute of Optics and Electronics, Chinese Academy of Sciences, and her Ph.D. Degree from King's College London.
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