Much has changed in China’s medical device regulations process in the past two years. This workshop will focus on the latest regulations for In Vitro Diagnostics (IVD) products from China’s National Medical Products Administration (NMPA), exploring the unique requirements, processes, and approval criteria for reagent products.
This workshop will present a systematic review of all elements in China’s regulatory process, from the clinical trial process to quality management, product registration, and postmarket surveillance.
This workshop will also include important discussions on specific regulations and guidance for companion diagnostics (CDx), the unique challenges, potential strategies, and pathways.
Led by instructors who are veteran regulatory managers, this workshop will also incorporate personal experience, knowledge, up-to-date information, and best practices.
This workshop will continue its tradition as an interactive forum for speakers and attendees. Speakers welcome and encourage questions and live discussions. Please submit your questions to the workshop chairperson or simply ask questions live during the workshop.
Registration Fees & Deadlines
Present - June 8, 2024: Member $825 |Nonmember $970
June 9, 2024 - July 8, 2024: Member $970|Nonmember $1150
Learning Objectives
After this program, participants will be able to:
- Understand NMPA’s regulations, processes, and requirements for IVD product registration.
- Identify key factors that would affect regulatory strategies and prepare for necessary adjustments.
- Gain up-to-date knowledge of current requirements and practices.
- Discuss their specific issues with presenters and other participants.
Who Should Attend?
This workshop is suitable for professionals with more than 3 years of experience, looking to broaden their knowledge base on international regulations or to focus on the Chinese market in the near future.
Agenda
Day 1 8:30 am – 12:30 pm (All times reflected in US Eastern Standard)
- Overview of regulations and framework for IVD reagents
- Product technical requirements and testing
Day 2 8:30 am – 12:30 pm (All times reflected in US Eastern Standard)
- Clinical trials for traditional IVD products
- Submission requirements
Day 3 8:30 am – 12:30 pm (All times reflected in US Eastern Standard)
- Regulations and guidance for CDx
- Clinical evidence for CDx
- Discussion on strategy and pathways for CDx
Speakers
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.
Quangang Qu, Roche Diagnostics, Head of Clinical Center of Excellence. Dr. Qu is now leading the CCoE team under Medical Regulatory Affairs in Roche Diagnostics China, with a broad scope from clinical portfolio management, clinical development, clinical quality, data management and statistical analytics. Before joining Roche Diagnostics China, Dr. Qu used to work for Medtronic, Beckman Coulter and Peking University Health Science Center. He has 14 years of experience in several areas including population-based epidemiological research, laboratory competency, regulatory affairs of medical device industry, clinical research, RWE/HEOR and business strategy and VBHC.
Qiman (Annie) Yin
Medical Regulatory Vice President, Roche Diagnostics (China)
Qiman (Annie) Yin currently holds the position of medical regulatory vice president, Roche Diagnostic (China). She has worked in the regulatory, clinical and medical, and quality fields within the pharmaceutical, medical device, and in vitro diagnostic sectors for more than 23 years with Eli Lilly, Roche Pharma R&D Center, Sanofi, Beckman Coulter, Medtronic, and Johnson & Johnson. Prior to that, Yin served as a hospital pharmacist for about three years. She is an active member of professional societies, including EUCCC HCE working group, AdvaMed, AHWP, the China Society for Drug Regulation (CSDR), the China Association of Medical Device Industry (CAMDI), and the Shanghai BME Association.
Sharon Cai
Sr. Regulatory Director, Roche Diagnostics, Shanghai Ltd.
Sharon Cai has more than 19 years of successful experience in the pharmaceutical, biological products, medical device, and in vitro diagnostic (IVD) products regulatory field. Cai currently is a committee member of STA/TC338, and a member of the biological IVD group of the China Medicinal Biotech Association. She holds a master’s degree in cell biology.
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
RAPS@raps.org