Time: Tuesday, November 12, 2019 | 11:00 am – 12:00 pm ET
Presented by China Med Device, LLC
This webinar will cover different clinical pathways and how to decide which pathway to choose to support NMPA (CFDA) medical device/IVD regulatory submission or post market surveillance. In addition to the traditional clinical evaluation report, we will go in-depth on the requirements for overseas clinical data acceptance and real world data/evidence in order to mitigate the clinical trial requirement. We will also cover key considerations on the feasibility and justification of overseas clinical data acceptance.
Finally, attendees will learn about the emerging use of Real World Data (RWD) being piloted in HaiNan, China – a cost-effective and less time-consuming 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, significantly shortening the time to begin selling devices in China. Don’t miss out on the opportunity to learn more about this new policy!
This informative webinar will provide you with:
- Key factors for China clinical strategy and pathways to support submission
- Main differences in China CER and EU CER
- Key factors to consider in using overseas clinical data
- Updates on the Real World Data pilot program to reduce clinical trial cost and time
Meet the Speaker:
Grace Fu Palma, CEO, China Med Device
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 enter China with NMPA (CFDA) regulation and CRO services. The company has processed 1,000+ NMPA (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 (Hewlett Packard Medical) and startup companies (Teratech). She specializes in China NMPA (CFDA) regulatory (RA/QA/CRO/CER) and commercialization services. In addition, she founded Chinese American Heart Association (500+ cardiovascular clinical professionals) in 2005. Regulator speaker at key national and local MedTech meetings, a frequent contribute writer to multiple journals, FDA News, RAPS Forum, Medtech News etc. She grew up in Beijing, China and received a BA degree from Peking University, China, and an MBA from Yale University in New Haven, CT.