[Webinar] Medical Device Real World Evidence (RWE) In China: Policies, Usage, Study Plan, Case Study

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Topic:

Medical Device Real World Evidence (RWE) in China: Policies, Usage, Study Plan, Case Study

Schedule:

Description:

In 2019, the China National Medical Products Administration (NMPA) launched an RWE Pilot Program in Hainan, where locates the International Medical Tourism Pilot Zone and Free Trade Port. In 2020, NMPA released a guidance for the implementation of real world data to the clinical evaluation of medical devices. In the same year, NMPA approved a Glaucoma Treatment System, the first medical device that used the RWE generated in Hainan to support its initial registration.

Many medical device manufacturers regard China as an essential part of the global regulatory strategy of their products. However, few regulatory professionals are familiar with the policy, application, and generation of RWE in China and how to leverage RWE to support China market entry and potentially support the clinical evaluation work for other countries. 

This webinar will discuss the policies and guidelines of RWE in China and use practical cases to illustrate how RWE is used to support life-cycle clinical evaluation, including pre-market approval, post-market clinical research, conditional approval, indication changes, long-term safety and efficacy assessment of medical devices, etc. This session will also cover the planning of RWE generation in China to support the manufacturer’s global clinical evaluation work.

Agenda:

• Overview of policies, regulations, and guidelines of RWE in China
• Usage of real world data for medical device life-cycle clinical evaluation including
  • pre-market approval,
  • post-market clinical research,
  • conditional approval,
  • indication changes, etc.
• Comparison of the usage of RWE in China and US
• How to plan and execute a real world study in the Hainan Tourism Pilot Zone
• Case Study: NMPA approvals with the support of real world evidence

Registration Link:

Time Option 1:

https://us06web.zoom.us/

Time Option 2:

https://us06web.zoom.us/

Speakers:

Mike Zhu, PhD

Vice President of Medical/Clinical Affairs, BradyKnows Medical

Dr. Zhu has over ten years of experience as a researcher and a regulatory/medical/clinical affairs leader at global leading medical device companies. He has extensive experience in global clinical evaluation, including EU MDD/MDR CER, China CER, TGA CER, etc.

Jocelyn Zhu

Director of Business Development, BradyKnows Medical

As the lead of BradyKnows Hainan company, Jocelyn has managed clinical trials and real-world studies in China inside out. She has hands-on experience in the planning and execution of real world studies in Hainan and maintains good communication with Hainan local government, local NMPA, hospitals, and KOLs for many therapeutics areas.

Tracy Yu

Senior Project Manager, BradyKnows Medical

Tracy Yu is a versatile regulatory and clinical research professional with nearly a decade of expertise. Her responsibilities include the development of regulatory and clinical strategies and management of pre-market approval projects from planning to completion, covering type testing, clinical trials/CER, consultation meeting with China NMPA reviewer, and post-market inspection and China localization projects.