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This workshop will cover different clinical evaluation and pathways and how to decide which pathway to choose to support China NMPA medical device/IVD regulatory approval or post market study requirements. With the release of “Regulation on the Supervision and Administration of Medical Devices”, Order 739 from the State Council, China NMPA is encouraging more versatile clinical evidence to support clinical evaluation to simplify the China NMPA regulatory approval process.
In addition to the traditional clinical evaluation report/clinical trial, we will go in-depth on the latest requirements for overseas clinical data acceptance and real-world data/study to mitigate the redundancy of clinical trial burden. Key considerations on the feasibility and gap justification of overseas clinical data acceptance will be discussed, especially the ethnic difference considerations.
Finally, attendees will learn about the emerging use of Real-World Data (RWD), other clinical evaluation alternatives such as CER, geographic special policies of real-world study –a faster alternative to the traditional clinical trial. Overseas manufacturers can obtain approval for the RWD pilot program through the Hainan provincial NMPA to start using devices in clinical settings prior to national NMPA approval, cutting years down to to months for the initial clinical use.
Don’t miss out on the opportunity to learn more about this new policy and the versatile clinical evidence updates from Order 739!
31 March 2021 - 27 April 2021: Early Bird $480 Member | $540 Nonmember
28 April 2021 - 26 May 2021: Regular $540 Member | $600 Nonmember
Grace Fu Palma has more than 20 years of medical technology and diagnostic industry experience. She is the CEO of China Med Device, providing turnkey solutions for western medical device/IVD/CDx products companies entering China. The company has processed more than 1,000 China National Medical Products Administration (NMPA) certificates, and accelerated more than 250 companies’ success. A seasoned bilingual and bicultural MedTech executive, Fu Palma has held a variety of marketing, operational and strategic development management positions at both large multinationals and startup companies. She specializes in China NMPA and commercialization services. She grew up in Beijing, and has a bachelor’s degree from Peking University, China, and an MBA from Yale University.
Yan Sheng grew up in China and has years of experience working in the life science industry in both the US and China, and has more than eight years of experience as a project manager at a CRO. She has experience with drug development companies in both the US and China such as Alfa Chemistry Inc. in the US, and Hangzhou Huadong Medicine Group Co. Ltd. in China. Sheng has six years of experience in the academic field working with cutting edge technologies in both chemistry and microbiology, and has extensive research expertise in natural products chemistry, molecular biology and microbiology, genetic manipulation, protein expression and purification, and in vitro enzymatic reactions. Sheng has been published in a number of academic journals and has a PhD in pharmaceutical sciences.
Dr. Gang Chen is Vice President of Medical Affairs for Genetron Health. Prior to joining Gentron Health, Dr. Chen served as Medical Affairs Director at Boston Scientific Greater China and Varian Medical Systems for 6 years. While working at Boston Scientific, he established a clinical evaluation team and lead the team to complete multiple Clinical Evaluation Reports (CER), with more than 20 new products received regulatory approvals in China via CER pathway. During 2009-2015, Dr. Chen served as Epidemiologist reviewer at FDAâ€™s Center for Device and Radiological Health. During his tenure at FDA, he actively involved in numerous PMA and PAS reviews, and participated in the development of multi-stakeholder National Medical Device Registry as FDA representative. Dr. Chen is also a special advisor for Hepatitis B Foundation, has been leading public health initiatives on hepatitis B and liver cancer prevention in US and China. He completed his postdoc training at Fox Chase Cancer Center after receiving MD and PhD in cancer epidemiology at Shanghai Medical University.
Vivian has 20+ years of experience on clinical research and medical affairs teams in pharmaceutical, IVD and medical devices industry. She has also led and supported different types of clinical evidence deliverables to support class II and class types of devices NMPA submission. Vivian has practical experience in China NMPA CER, overseas clinical data acceptance, clinical trial and post market clinical follow up studies.
Dr. Xiaoguang Ma works as an associate regulatory affairs director for Medtronic Greater China and leads a team providing expertise and guidance on registration strategy, clinical evaluation, and epidemiological and biostatistical methods. He currently serves as the chair of the Clinical Evaluation Task Force at COCIR, European trade association for the medical imaging, radiotherapy, health ICT and electromedical industries. Ma has worked in the healthcare system with both academia and industry for more than 14 years. Before joining Medtronic, he was an associate professor at Zhejiang University School of Public Health, and published more than 30 scientific papers and co-authored or editied several textbooks. He received his MD from Peking University, MPhil in public health from the University of Hong Kong, and PhD in epidemiology and biostatistics from the University of South Carolina.
Qianqian Zhu has more than eight years of experience working on China NMPA registration, covering type test and clinical trials, and has obtained more than 20 approvals of Class III medical devices, IVDs and drugs in China. Zhu is an expert on China CER and PRER technical writing. She has worked with China’s Center for Medical Device Evaluation (CMDE) on the drafting and release of five technical review guidance documents. Zhu also worked with the Beijing Institute of Medical Device Testing (BIMT) and the National Institutes for Food and Drug Control (NIFDC) on national standards development. She practiced law and worked on international trade in China and the UAE prior to coming to the US, and she has the RAC (Global).
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 via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and the event title. Substitutions may be accepted with written approval from RAPS and must be submitted to firstname.lastname@example.org.
Following the virtual event, please complete the evaluation survey located in the RAPS Learning Portal. Attendees will then have immediate access to their Certificate of Attendance.
Call RAPS Solutions Center at +1 301.770.2920, Ext 200 or email email@example.com.