China NMPA Clinical Evaluation and Trial Key Changes to Support Order 739 Webcast

The session will cover the evolving regulations related to the main changes by China NMPA in support of its overarching policy, Order 739, “Regulation on the Supervision and Administration of Medical Devices”. It will review the impact on clinical evaluation pathways, clinical evaluation principles and processes, clinical evaluation reports and data appraisal, Good clinical practice (GCP) and Clinical trial permission (CTP). There have been significant updates as part of the continuous China NMPA regulatory transformation process.

This webcast will review Order 739 from China State Council which covers the complete product life cycle with a positive direction to more efficient and less burdensome approval process. Attend this live broadcast to learn the key highlights of clinical evaluation and clinical trial related changes and updates.

Agenda

TBD

Learning Objectives

At the conclusion of the workshop, participants should be able to:

• Understand the new framework and key clinical evaluation changes for writing CER with the implementation of Order 736
• Learn to use more versatile clinical evidence to support clinical evaluation and fast approval pathways for urgent use/innovation
• Learn how to conduct clinical evaluations and how to prepare clinical evaluation reports
• Understand how to demonstrate equivalence
• Learn methods for determining if clinical trials are necessary

Pricing Amounts & Deadlines 

Complimentary

Who Should Attend? 

• E.g. Device Regulators
• Regulatory affairs professionals
• Clinical affairs professionals
• Managers in the life sciences industry
• Quality affairs professionals
• Medical affairs professionals
• R&D managers
• Compliance managers
• Operations managers
• Marketing and business executives
• Chief financial and commercial managers

Speaker(s)

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.

Yan Sheng, Ph.D.

Project Manager, China Med Device LLC

Yan Sheng grew up in China and has years of experience working in the life science industry in both the US and China and has more than eight years of experience as a project manager at a CRO. She has experience with 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. Sheng has six years of experience in the academic field working with cutting edge technologies in both chemistry and microbiology, and has extensive research expertise in natural products chemistry, molecular biology and microbiology, genetic manipulation, protein expression and purification, and in vitro enzymatic reactions. Sheng has been published in a number of academic journals and has a PhD in pharmaceutical sciences.

Mingdong Zhang, MD, MPH.,PhD.

Chief Medical Officer and Vice President of Medical Affairs, Boston Scientific Asia Pacific

Mingdong Zhang is chief medical officer and vice president of medical affairs for Boston Scientific Asia Pacific. Previously, he served as chief medical officer and vice president of medical and regulatory affairs for Boston Scientific Greater China. Prior to joining Boston Scientific, Mingdong served as global medical director for Johnson & Johnson’s electrophysiology business in Southern California for more than four years, and as a medical officer/epidemiologist at US FDA’s Center for Devices and Radiological Health (CDRH). He also spent eight years conducting academic and clinical research at the US National Institutes of Health as a research fellow and staff scientist, and at the medical school of the Chinese University of Hong Kong as a professor. Mingdong graduated from Shanghai Medical University with a MD and MPH in epidemiology. He earned his PhD in molecular virology from Baylor College of Medicine.

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 to support@raps.org. RAPS is unable to accept cancellations by phone. 

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee. 

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance at the following the workshop.

Questions