The new Hainan Real World Data (RWD) policy allows for unapproved NMPA devices in China to be sold and used in clinical settings. The China Hainan Real-World Data/Study (RWD/S) Pilot Program reduces the approval process from years to months, which allows for medical devices from overseas, IVDs and drugs that have NOT been approved in China to be used in clinical settings in the Lecheng Hainan Province. This is especially significant for overseas manufacturers with high-value and innovative devices that normally require clinical trials by the China NMPA. This webinar will provide fantastic value and guidance of the RWD/S program will be provided by Hainan officials. Register for this webinar on Wednesday, December 2 from 10:30 AM – 11:30 AM ET to find out more about how you can benefit from the program to accelerate your China commercialization.
- What are the latest scope/requirements for Hainan urgent use and RWD/S Pilot program?
- How to leverage the RWS evidence to supplement the NMPA regular submission
- Learn about the latest practices and case studies of Hainan RWD program
- How you can benefit from the program to accelerate your China commercialization with RWD/S
Grace Fu Palma, MBA, CEO, China Med Device, LLC
Grace brings 20+ years of industry experience to the medical device industry. She is the CEO of China Med Device (www.ChinaMedDevice.com) with offices in Beijing and Boston providing turnkey solutions for western medical device/IVD/CDx/combination products companies to entier China with NMPA (CFDA) regulation and CRO services. The company has processed 1,000+ CFDA certificates, 250+ Chinese and western companies' success. A seasoned bilingual and bicultural MedTech executive, she held a variety of marketing, operational and strategic development management positions at both large multinationals and startups. She specializes in China NMPA (CFDA) regulatory (RA/QA/CRO/CER) and commercialization services. In addition, she founded the Chinese American Heart Association (CNAHA) (500+ cardiovascular clinicians) in 2005. A regular speaker at key national and local MedTech meetings, and frequent contributing writer to multiple journals. She grew up in Beijing, China and received a BA from Peking University, China and an MBA from Yale University in New Haven, CT.
Jason Zhang, MD, Director of CRO, China Med Device, LLC
Jason Zhang, MD, is the director of CRO services at the Beijing office of China Med Device, LLC (www.ChinaMedDevice.com). With 12+ year in clinical trial, clinical evaluation, real world study and other clinical research management experience, Jason manages CER writing, overseas clinical data review and analysis, and real-world data and study. He also supervises full service CRO related activities at China Med Device.
He held a patent at Philips, several publications in MRI guided HIFU. Worked as the clinical affairs manager at Philips Healthcare and clinical data manager at Merck & Co. Jason has proven track record in the entire spectrum of clinical trials, from site selection to the preparation of PRT, CIB, CRF, ICF, IRB, and PRT discussion meeting, clinical data monitoring, management, statistical analysis, clinical research, evaluation and reporting and final site closing. Product examples include, but not limited to: NanoFuse for bone trauma, Hemoconcentrator, Focused ultrasound for contouring, Precision infusion project, Polysaccharide hemostatic material project. MR-HIFU (MR guided High Intensity Focused Ultrasound) in Uterine Fibroid treatment, MRI imaging systems etc.
Jason received MD from North China Medical College (NCMC) and master in Pathology from Peking Union Medical College (PUMC) with specialties in Clinical Medicine, Clinical Pharmacology, Pharmacology, and Medical Statistics etc.
Sun Xin, Professor and Director of Clinical Epidemiology and Evidence-based Medicine Research Center, West China Hospital, Sichuan University in Chengdu, China
Dr. Xin Sun is Professor and Director of the Clinical Epidemiology and Evidence-based Medicine Research Center at West China Hospital, Sichuan University in Chengdu, China. He also serves as the director of Chinese Evidence-based Medicine Center, Cochrane China Center, IDEAL China Center and MAGIC China Center, and works as Executive Editor-in-Chief of the Chinese Journal of Evidence-based Medicine and Journal of Evidence-based Medicine, and associate editor of Value in Health Regional Issue. Dr. Sun is an external expert of the Center for Drug Evaluation (CDE), Center for Medical Devices Evaluation (CMDE), and Center for Drug Re-evaluation (CDR) of National Medical Products Administration.
Dr. Sun leads a group of researchers (CREAT Group) with particular research interests in medical products evaluation and policy research (i.e., regulatory and insurance policy); and disease management and healthcare policy research. In the past several years, Dr. Sun has received over 20 public research grants including those from Natural Science Foundation of China, Chinese Ministry of Science and Technologies, National Medical Products Administration, and China Medical Board. He has published over 110 peer-reviewed articles, including those published in NEJM, JAMA, and BMJ. He became the most productive BMJ author from China, and recently received the BMJ Award for excellence in research.
Dr. Sun also severs as President of ISPOR West China Chapter, Vice Chairs of Evidence-based Medicine Committee of the Chinese Medical Doctor Association, Rational Drug Use Committee of the Chinese Geriatric Research Association, and Evidence-based Pharmacy Committee of the Chinese Pharmacy Association.