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This workshop will focus on China’s NMPA regulations for In Vitro Diagnostics (IVD) products, exploring the unique requirements, processes, and approval criteria for reagent products, in comparison to regulations for IVD instruments. This workshop will present a systematic review of all elements in the Chinese regulations from clinical trial, to quality management, product registration and post market surveillance.
By participating in this workshop, attendees will be able to:
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 is suitable for professionals with more than three years of experience, looking to broaden their knowledge base on international regulations or to focus on the Chinese market in the near future.
19 November 2020 – 15 July 2021: Early Bird $800 Member | $900 Nonmember
16 July 2021 – 15 August 2021: Regular $900 Member | $1000 Nonmember
Day 1 Monday, 16 August 2021
9:00 - 9:15 am Welcome, introduction of speakers and class schedule
9:15 - 10:45 am NMPA - structure, responsibilities, and key regulations
10:45 - 11:00 am Break
11:00 - 12:00 pm Classification and testing
12:00 - 1:00 pm Lunch
1:00 - 2:30 pm Clinical Evaluation and Clinical Trial
2:30 - 2:45 pm Break
2:45 - 3:45 pm Pathways: traditional vs. new
3:45 - 4:15 pm Panel discussion
Day 2 Tuesday, 17 August 2021
9:00 - 10:30 am Pre-submission: dossier, key documents and filing review
10:30 - 10:45 am Break
10:45 - 11:15 am Submission and review by NMPA, consultation with NMPA
11:15 - 12:00 pm Amendments and renewal
12:00 - 1:00 pm Lunch
1:00 - 2:00 pm Post-market Risk Re-evaluation and its comparison to EU MDR requirements
2:00 - 3:00pm Quality - Manufacturing, distribution, field inspection; UDI
3:00 - 3:15 pm Break
3:15 - 3:45 pm Strategic considerations for China
*All agendas are subject to change
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..
Qiman (Annie) Yin, Medical Regulatory Vice President, Roche Diagnostics (China) 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 is senior regulatory director, Roche Diagnostics, Shanghai Ltd. She 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.
Yin Huang, MS, Regulatory Affairs Specialist, Ortho Clinical Diagnostics joined the international regulatory affairs team at Ortho Clinical Diagnostics as a regulatory affairs specialist in 2018. She is mainly responsible for transfusion medicine and clinical chemistry product registrations. Huang has considerable experience in product extension and change permission in China. She is an expert on regulatory requirements for product change from China’s National Medical Products Administration (NMPA). Huang also has worked as a project lead in the bioinformation center of the Shanghai Institute of Biological Sciences, and as scientific editor at biomedical journals. She has a master’s degree in genetics and holds the RAC credential. p>
Weiping Zhong, PhD, Global Director of Risk Management, GE Healthcare is the global director of risk management for GE Healthcare (GEHC), leading risk management, cybersecurity-safety risk management, and clinical evaluation for all GEHC device products covering imaging, patient care, and digital healthcare. Prior to joining GEHC, Weiping held multiple positions in Bayer Healthcare – Diabetes Care, including QA/RA head for APAC, statistician, and reliability and quality engineer. He holds a PhD in mechanical engineering and a master’s in industrial and operations from the University of Michigan, as well as a master’s in mechanical engineering from Dalian University of Technology in China. p>
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.
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cancellations by phone. Please specify the name of the person registered and event title.
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