Webcast: Fast-Track Your Initial Clinical Use in China with the Hainan RWD/S Pilot Program
1.0
RAC CREDITS
Wednesday, 18 November 2020 (11:00 AM) – (12:00 PM) Eastern Time (US & Canada)
Learn how the Hainan Real-World Data/Study (RWD/Study) pilot program can shave months off your timeline for initial clinical use of NMPA unapproved devices in a real-world setting. This initiative allows overseas medical devices, IVDs and drugs that have NOT been approved in China to be sold and used in real world clinical settings in Lecheng Hainan province and is particularly significant for overseas manufacturers with high-value and innovative devices that normally require clinical trials by China NMPA.
In this webcast you’ll receive guidance on how the program works, and the RWD/S in NMPA registration approval directly from Hainan officials. Tune in to learn if and how the program can accelerate your commercial sales and registration in China.
Key Highlights:
- The latest scope and requirements for urgent use and Hainan RWD/S Pilot program
- How to leverage the RWS evidence to supplement the NMPA regular submissions
- The latest practices and case studies of the Hainan RWD/S Pilot program
- How overseas device manufacturers can benefit from the Hainan RWD/S Pilot program
- How to determine whether your unapproved device meets Hainan program requirements
Learning Level:
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Who should attend?
- Clinical affairs professionals
- Managers in the life sciences industry
- Regulatory affairs professionals
- Quality affairs professionals
- Medical affairs professionals
- R&D managers
- Compliance managers
- Operations managers
- Marketing and business executives
- Chief financial and commercial managers
Speakers
Gu Gang
President of LeCheng Medical Pilot Zone Bureau
Gu Gang is currently Secretary of the Party Committee and Chairman of Hainan Development Holdings Co., Ltd., the Director of the Administration Bureau of Hainan Boao Lecheng International Medical Tourism Pilot Zone, and the Executive Chairman of Hainan Airlines. He has served as the Secretary of the Party Committee and Chairman of Hainan Development Holdings Co., Ltd. since September 2018. He has served as the director of the Hainan Boao Lecheng International Medical Tourism Pilot Zone Administration since August 2019, and has also served as the executive chairman of Hainan Airlines in since March 2020.
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 currently serves as the director of Chinese Evidence-based Medicine Center, Cochrane China Center, IDEAL China Center and MAGIC China Center. He also 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 on the Center for Drug Evaluation (CDE), Center for Medical Devices Evaluation (CMDE), and Center for Drug Re-evaluation (CDR) of National Medical Products Administration in China.
He 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. Over 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 serves 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.
Grace Fu Palma,
CEO, China Med Device LLC
Grace brings 20+ years of MedTech and diagnostic industry experience. She is the CEO of China Med Device (www.ChinaMedDevice.com) with offices in Beijing, Hainan and Boston, providing turnkey solutions for western medical device/IVD/CDx products companies to enter China with NMPA (CFDA) regulatory and clinical affairs (RA, QA, CER, RWD, CRO etc.) services. The company has processed 1,000+ NMPA certificates and accelerated 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 startup companies. She specializes in China NMPA (CFDA) regulatory (RA/QA/CRO/CER) and commercialization services. In addition, she founded the Chinese American Heart Association (500+ cardiovascular clinical professionals) in 2005. She is a regular speaker at key national and local MedTech meetings and a frequent contributing writer to multiple regulatory journals. Grace grew up in Beijing, China and received a BA degree from Peking University, China, and an MBA from Yale University in New Haven, CT.
Event Information
Event Topic:
Webcast: Fast-Track Your Initial Clinical Use in China with the Hainan RWD/S Pilot Program
Event Description:
Date/Time:
Date(s) - 11/18/20
8:00 am - 9:00 am
Event Location:
Other: Webinar- requires registration
Event Details
Event Type