Visit China Med Device at RAPS October 1 – 4th in Vancouver and Get the Latest Update on NMPA (formerly CFDA) and a Glamor Shot!
China Med Device, LLC is presenting and exhibiting at RAPS Annual Conference on October 1st – 4th in Vancouver. We are also the sponsor of Glamor Shot.
CMD’s CEO Grace Palma, and Clinical Director, Jason Zhang, MD, will present on “What are the Practical CFDA Compliant Clinical Trial Tips in China in 2018?” from 10:30-11:30 AM on Thursday, Oct 4th, in Room 205-207, Vancouver Convention Center.
Please visit us at booth #502 to find out the latest updates and the major structural changes of NMPA (Formerly CFDA). To schedule your meeting or request more information, please contact us at info@ChinaMedDevice.com.
We at China Med Device, LLC are the thought leaders and experts to guide you through these changes, from RA, clinical evaluation, CRO, to QA and post-market compliance. We are a CFDA certified legal agent.
Grace Fu Palma, a Sino-US MedTech veteran, founded China Med Device (www.ChinaMedDevice.com) to provide turn-key solutions for western medical device/IVD/combination products’ companies to enter China with regulation and commercialization services. With 20+ years of experience driving global product strategy, commercialization, partnerships, and China operations for both large multinationals and startup companies, she has held a variety of management positions in marketing and operations at multinationals and start-ups. She founded the Chinese American Heart Association in 2005. She has been a speaker at national regulatory meetings as well as a column contributor for US regulatory news and journals.
Jason Zhang, MD, has 10+ year clinical trial and management experience in China. With his expertise in clinical design, data quality in CRC and CRA, reporting and evaluation, Jason has managed the clinical trial for oncology positioning system, ultrasound, MRI and CT and other diagnostic products. He designed and completed the clinical trial for the 1st domestic Linear Accelerator in China with 75 patients in less than a year. It was approved by CFDA through Innovation Device pathway. He is also a patent owner at Philips and has several publications on MRI guided HIFU.
China has 5 times the U.S. population with extremely concentrated care. For instance, in the case of annual outpatient visits, China 1st Affiliated Hospital of Zhengzhou University has annual outpatient visits of 100 Million whereas Mass General Hospital in Boston only has around 1.5 Million. The advantage of being able to recruit patients quickly and utilizing the NMPA (CFDA)compliant data to shorten regulatory approval time in China could help generate revenues years ahead from the 2nd largest medical device market, China.
Chinese culture and clinical practice are very different from that in the U.S. The accepted practice and international regulations of FDA are not always being applied the same way at NMPA (CFDA). The value of the session is to equip you with key areas that you need to pay attention so as to have the right strategy and tactics to shorten clinical trials and approval times. You will be able to understand the China perspective and have actual tips on how to best work with your Contract Research Organization (CRO) and get to China even before you have your FDA or CE approval. We will discuss how to be more proactive to improve the overall CRO process and get your new products available faster for the Chinese population from clinical trial strategy, clinical trial study design, and clinical trial protocol, calculation of sample size, on-site management and data integrity to achieve the primary and secondary end points.
About China Med Device
China Med Device, LLC (www.ChinaMedDevice.com) provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, RA, clinical evaluation, CRO, QA and post market compliance. We are experienced in handling innovation approvals and priority reviews. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 250+ companies’ success.