Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Our new book is a comprehensive look at a vital part of medicines development and regulatory affairs. Grab your copy today!
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
“How can we expedite the approval of our product?” this is the question every regulatory professional asks themselves daily.
Regulations shift continuously as result of changes in national and international, political, economic, and healthcare environments. As regulators around the globe observe and learn from each other, their policies evolve as the government agencies try to balance risks and benefits of their decisions. All this, while maintaining support of technology innovations, healthcare services for the population, and even for national security interests.
This workshop brings together experts from many different locations to discuss regulations in the US, EU, Canada, Australia, China, Japan, and South Korea. During this workshop we will explore special programs, policies and practices that these countries and regions have installed to foster adaption of new technologies, to address unmet clinical needs, and to respond to national health emergencies. The workshop will also feature corporate executives to discuss corporate strategies and market access, where regulatory is just a piece of a larger puzzle.
This workshop is aimed at providing the fundamentals that attendees can use as well as high-level perspectives that may shape a company’s business and regulatory strategies.
Day 1: Monday, Nov 15, 2021
Day 2: Tuesday, Nov 16, 2021
* agenda is subject to change
Chair of Faculty: Chang-Hong Whitney, RAC, MBA
President & CEO, Whitney Consulting Ltd.
Chang-Hong Whitney has spent more than 30 years in the medical device industry in both China and the US. She founded Whitney Consulting Ltd., focusing on Chinese regulations for medical devices and IVDs, servicing exclusively international clients around the world, including Fortune 500 companies. Whitney is an active member of the RAPS community, presenting China regulatory updates at RAPS conferences, organizing workshops and seminars, editing educational material, and serving on volunteer committees. She holds an MBA from Babson College and undergraduate degrees in electrical engineering and international business in China.
Patrick Lee, RAC MSPatrick Lee is currently the director of regulatory affairs at a device and biologics company in California. He has been involved in regulatory, quality, and clinical activities at various Bay Area medical device companies for 20 years. Lee has worked on products such as neuro-implants, cardiovascular devices, cellular therapy, blood processing, stem cell harvesting, drug delivery, and laser and electro-mechanical devices. He has been involved in FDA, CE marking, and many OUS regulatory submissions and approvals. Lee has been a long-time instructor for various institutions including the University of California at Santa Cruz, RAPS and ASQ. He received his academic degrees from Cornell, Columbia, and UCLA, and is a licensed professional engineer in New Jersey and California. Lee is RAC (US) and CQA certified.
Fumiaki Ikeno, M.D.Fumiaki Ikeno graduated from Jichi Medical University in Shimotsuke, Japan with an MD. He began his research career in the department of cardiology at Stanford University in 2001, where he was involved in research and development, animal testing, and clinical trials for US medical device companies. Ikeno has been teaching at Stanford since 2002 as a Stanford Biodesign Advisory Faculty member, where he is training medical device entrepreneurs. He is a co-author of more than 90 scientific peer-reviewed papers. Ikeno has extensive advisory experience in the medical device field in Japan and the US. He is deeply involved in the establishment of the Japanese version of Stanford Biodesign program, and is working to establish a Silicon Valley-style medical device ecosystem in Japan, as well as a cross-border medical device ecosystem. Ikeno has been a member of the “Harmonization by Doing” Working Group since 2008, instrumental in facilitating joint review efforts between US FDA and Japan’s PMDA.
Kirk Zeller, DBA (Doctorate of Business Administration)Kirk Zeller is a healthcare entrepreneur, who is passionate about bringing innovative medical devices to market. Over his 27-year career, He has facilitated the launch of a wide range of medical devices in international markets, and is a frequent speaker on related topics. Zeller is a board member of US Japan MedTech Frontiers, a non-profit working to enhance collaboration between the US and Japan on healthcare. He is co-founder and actively involved in two market access firms: Nichibei MedTech Advisors, LLC (US market entry) and MedMarket Access, LLC (Japan, Asia, and Latin America market entry). Zeller is the founder of the Silicon Prairie Center, a unique entrepreneur live-work community, and co-founder of two healthcare companies incubated at the center. He has a Doctorate of Business Administration (DBA) from the International School of Management (Paris) and an MBA from Imperial College London with a specialization in biopharma and health technology entrepreneurship.
Young KimYoung Kim has worked at public and private medical and pharmaceutical companies for more than 25 years. She founded Synex Consulting, Ltd., a Seoul-based consulting firm specializing in solutions for regulatory approvals, clinical trials, reimbursement listing, market research and business model development, in 2002. Kim is active in the Korea Medical Device Industry Association, Korea Society of Food, Drug and Cosmetics Regulatory Sciences, and the Korea Association of Health Technology Assessment. She also has been invited to advisory roles to Korea Food and Drug Administration (KFDA), Health Insurance Review and Assessment Service (HIRA), and Ministry of Health and Welfare (MOHW). Prior to starting Synex, she worked at the US Embassy in Soul as senior commercial specialist, focusing on market access to the Korean healthcare industry, and participated in US-Korea bilateral trade policy negotiation.
Mark Swanson, MBA BS MBA, ASQ CMQ/OE, CQE, CMDAMark Swanson is the president and lead consultant of Quality and Regulatory Expert Partners, LLC, a partnership focused on supporting small to mid-sized companies’ regulatory and quality systems. He has more than 20 years of experience in the medical device industry, including numerous quality and regulatory roles. Swanson is a senior member of ASQ, a RAPS member, and a corporate AAMI member, serving on several AAMI standard development committees. He is an active member of ISO Technical Committee 210 (ISO TC210), Working Group 1 (WG1) working on ISO 13485 - 2016, a co-lead for ISO 13485 guidebook and a lead US member of Working Group 6 (WG6) on postmarket surveillance (ISO TR 20416). He has participated with ISO TC176 on ISO 9000/9001:2015 and in the AAMI group responsible for TIR 102, to formally compare ISO 13485 to the US FDA Quality System Regulation. Swanson also participated in the US TAG for risk management (ISO 14971) and the workshop that created IWA 31 (agreement on the application of risk management in standards).
Roaida Johnson, BS, MARoaida Johnson has more than 18 years of experience in the medical device industry, working in regulatory affairs. Currently, she is leading the regulatory effort at Hyperfine, where she is responsible for US FDA and global registrations for its portable MRI device. Prior to being at Hyperfine, Johnson was responsible for global registrations for a range of women's health and fertility products at CooperSurgical. She also has held management positions in the orthopedic spine industry, has worked in minimally invasive technology, and in mammography. She has a master’s in international relations from the American Graduate School in Paris.
Rachel Chung, Managing Director/Medical Device Group 1, Synex Consulting, Ltd.