China NMPA (CFDA) Regulatory Approval: Clinical Evaluation and Pathways

6.0 RAC Credits On-demand     Member: $480.00 Nonmember: $540.00


China NMPA (CFDA) Regulatory Approval: Clinical Evaluation and Pathways

This is an On-demand recording from May 2021 

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!

Pricing Amounts & Deadlines

31 March 2021 - 27 April 2021: Early Bird $480 Member | $540 Nonmember

28 April 2021 - 26 May 2021: Regular $540 Member | $600 Nonmember

Objectives

  • Learn about different clinical evaluation pathways and how to decide which pathway to choose to support NMPA (CFDA) medical device/IVD regulatory approval or post market study.
  • Equip you with key areas that you need to pay attention to have the right strategy and tactics to shorten clinical trials and approval times.
  • Find out whether your devices qualify for the real-world data/study Hainan program and how to get into the program to cut initial commercial use by over a year.
  • Key considerations on the feasibility and gaps justification of overseas clinical data acceptance.
  • How to be more proactive to improve the overall CRO process and get your new products available faster to China market through versatile clinical evaluation evidence.

Who Should Attend?

  • All RA Professionals
  • Clinical affairs professionals
  • Managers in the life sciences industry
  • Quality affairs professionals
  • Medical affairs professionals
  • R&D managers
  • Compliance managers
  • Operations managers

Agenda

  • Clinical Pathways Overview in Support of Regulatory Approval
  • Overseas Clinical Data Acceptance Deeper Dive with Real Cases
  • CER, Clinical Trial and Real-World Data with Real Cases
  • IVD Assay Clinical Evaluation Special Considerations and Pathways
  • Roundtable Q&A and Summary Remarks from all Speakers

Speakers

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 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. Regular speaker at key national and local MedTech meetings, 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.


Yan Sheng, PhD, Project Manager, China Med Device LLC

Yan Sheng grew up in China with years of working experience in life science industry in both US and China. She has 8+ Years’ experience in life science industry as project managers at CRO and 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. She also has 6 years’ experience in academic field, familiar with cutting edge technologies in both chemistry and microbiology field. In addition, she has extensive research expertise in natural products chemistry, molecular biology and microbiology, genetic manipulation, protein expression and purification, in vitro enzymatic reactions.

Dr. Sheng has published journals such as Organic Letters, Journal of Natural Products, Applied Microbiology and Biotechnology, Journal of Shenyang Pharmaceutical University etc. Dr. Sheng earned her B. S. in Pharmacy and Ph.D Pharmaceutical Sciences.


Mingdong Zhang, M.D., M.P.H., Ph.D., Chief Medical Officer and Vice President of Medical Affairs for Boston Scientific Asia Pacific

Dr. Mingdong Zhang is currently Chief Medical Officer and Vice President of Medical Affairs for Boston Scientific Asia Pacific, promoted from the position of Chief Medical Officer and Vice President of Medical and Regulatory Affairs for Boston Scientific Greater China in 2019. Prior to joining Boston Scientific in December 2012, Mingdong was the Global Medical Director for the Johnson & Johnson’s electrophysiology business in Southern California for more than four years. Before J&J, Mingdong was a Medical Officer/Epidemiologist at US FDA’s Center for Devices and Radiological Health (CDRH) from 2007 to 2008. In his earlier career path post his medical and graduate training, Mingdong spent eight years doing academic and clinical research at the US National Institutes of Health as a Research Fellow and Staff Scientist and the Medical School of the Chinese University of Hong Kong as a professor, publishing over 40 papers in high impact journals such as Lancet, PNAS, JNCI, Blood, Gastroenterology, and Hepatology.

During his service in CDRH/FDA, Dr. Zhang provided medical reviews for multiple original PMAs and 510k submissions on medical devices including IVDs; led designs of post-approval studies; and performed risk assessment and health hazard evaluations of medical devices.

Mingdong graduated from Shanghai Medical University with a MD and MPH in Epidemiology. He then earned his PhD in Molecular Virology from Baylor College of Medicine in Houston, Texas.


Xiaoguang Ma, MD, Associate Regulatory Affairs Director from Medtronic Greater China

Dr. Xiaoguang Ma works as an Associate Regulatory Affairs Director from Medtronic Greater China and leads a team to provide guidance and expertise on registration strategy, clinical evaluation, as well as epidemiological and biostatistical methods. He currently serves as the chair of Clinical Evaluation Task Force at COCIR (the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry), and also serves as associate chair, secretary general, or member of several medical associations, and invited reviewer for a number of scientific journals. Dr. Ma has worked in the healthcare system with both academia and industry experience over 14 years. Before joining Medtronic, Dr. Ma was an associate professor at Zhejiang University School of Public Health, and was a well-recognized scholar who published over 30 scientific papers, received over $200,000 grants from various funding agencies, and co-authored/editied several textbooks. He received his MD degree in preventive medicine from Peking University, MPhil degree in public health from The University of Hong Kong, and PhD degree in epidemiology and biostatistics from University of South Carolina.

Cancellation Policy

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 raps@raps.org.

Proof of Attendance

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.

Questions

Call RAPS Solutions Center at +1 301.770.2920, Ext 200 or email raps@raps.org.