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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
“Can our breakthrough device be marketed in other countries?” “How can we expedite the approval of our product?” These are the questions that we in the regulatory positions ask ourselves everyday.
Regulations shift continuously as result of changes in national and international, political, economic, and healthcare environments. As technologies brought upon new innovations resulting in breakthroughs in treatment and recovery.
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 different locations to discuss regulations in the US, EU, Canada, Australia, China, Japan, and South Korea. Other countries and regions may be added if time allows.
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 a corporate executive 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.
Present until September 25: Early Bird $825 Member | $970 Nonmember
September 26 – through October 25 2022: Regular $970 Member | $1150 Nonmember
Day 1: Tuesday, October 25, 2022 9am – 4pm EST
Day 2: Wednesday, October 26, 2022 8:30am – 4pm EST
* agenda is subject to change
Chair of Faculty:Chang-Hong Whitney, RAC, MBAPresident & 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 MS
Patrick 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.
Young 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.
Sanyam GandhiRegulatory Strategy Lead, Takeda
Sanyam has Master’s degree in pharmacy and has spent 13 years in Regulatory Affairs-, Pharma, Biotech, Rare Diseases and Generics. His regulatory affairs responsibilities cover strategic planning and project management with emphasis on executing regulatory strategies, CMC-CTA authoring, and submissions. He is experienced in early sate development, such as MAA planning, IMPD, Scientific discussion and meetings with health Authorities, CMC Strategy, local requirements, as well as in post approval management, such as variations, PSUR Submissions, safety updates, CCDS update, site transfer project, change controls, annual reports, GAP analysis, renewals, compliance support. He has been certified for many regulatory and project management disciplines with RAPS (USA), TOPRA (UK) and Management forum. He won TOPRA award nomination in “Contribution” category 2021.
Roaida Johnson, BS, MA
Roaida 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.
Sanjay Shah, BS, P.Eng.Associate Director of Regulatory Affairs, LABORIE
Sanjay is a mechanical engineer with more than 20 years of experience in the medical device industry, mainly in global regulatory affairs, quality and compliance. Sanjay has worked on products such as Radiological device, Electro-mechanical devices, Image Guided Therapy solutions, Software, Catheters, Neurosurgery, Urology, and GI devices in many medical device companies in Twin cities. He has been involved in FDA, CE marking, Health Canada and many global regulatory submissions and approvals. Sanjay is a licensed professional engineer in Manitoba, Canada and has a master’s in industrial management.
* Speakers are subject to change. Other speakers may be added at later date.
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