China NMPA Regulations on IVD and Companion Diagnostics

12.0
RAC Credits
Virtual ProgramsVirtual Programs
Tuesday, 11 April 2023 (8:30 AM) - Thursday, 13 April 2023 (12:30 PM) Eastern Time (US & Canada)

Much has changed in the Chinese medical device regulations process in the past two years. This workshop will focus on the latest NMPA regulations for In Vitro Diagnostics (IVD) products, exploring the unique requirements, processes, and approval criteria for reagent products. This workshop will present a systematic review of all elements in the Chinese regulatory process from the clinical trial process, to quality management, product registration, and post-market surveillance.

This workshop will also include important discussions on specific regulations and guidance for companion diagnostics (CDx), the unique challenges, potential strategies, and pathways.

Led by instructors who are veteran regulatory managers, this workshop will also incorporate personal experience, knowledge, up-to-date information, and best practices.

This workshop will continue its tradition as an interactive forum for speakers and attendees. Speakers welcome and encourage questions and live discussions. Please submit your questions to the workshop chairperson or simply ask questions live during the workshop. 


Learning Objectives

After this program, participants will be able to:

  • Understand NMPA’s regulations, processes, and requirements for IVD product registration.
  • Identify key factors that would affect regulatory strategies and prepare for necessary adjustments.
  • Gain up-to-date knowledge of current requirements and practices.
  • Discuss their specific issues with presenters and other participants.

Registration Fees & Deadlines

 

Members

Non-Members

Early Bird 16 October 2022

$825

$970

Regular by 11 April 2023

$970

$1150


Who Should Attend?

This workshop is suitable for professionals with more than 3 years of experience, looking to broaden their knowledge base on international regulations or to focus on the Chinese market in the near future.


Agenda

Day 1 – April 11, 2023, 8:30 am – 12:30 pm (All times reflected in US Eastern Standard)

  • Overview of regulations and framework for IVD reagents
  • Product technical requirements and testing

 

Day 2 – April 12, 2023, 8:30 am – 12:30 pm (All times reflected in US Eastern Standard)

  • Clinical trials for traditional IVD products
  • Submission requirements

 

Day 3 – April 13, 2023, 8:30 am – 12:30 pm  (All times reflected in US Eastern Standard)

  • Regulations and guidance for CDx
  • Clinical evidence for CDx
  • Discussion on strategy and pathways for CDx

Instructors:

Chang-Hong Whitney

Chang-Hong Whitney, MBA, RAC

Chang-Hong Whitney has spent more than 30 years in the medical device industry in both China and the US. She founded Whitney Consulting Ltd., focusing on Chinese regulations for medical devices and IVDs, servicing exclusively international clients around the world, including Fortune 500 companies. Whitney is an active member of the RAPS community, presenting China regulatory updates at RAPS conferences, organizing workshops and seminars, editing educational material, and serving on volunteer committees. She holds an MBA from Babson College and undergraduate degrees in electrical engineering and international business in China.

Qiman Yin

Qiman (Annie) Yin, Medical Regulatory Vice President, Roche Diagnostics (China)

Qiman (Annie) Yin currently holds the position of medical regulatory vice president, Roche Diagnostic (China). She has worked in the regulatory, clinical and medical, and quality fields within the pharmaceutical, medical device, and in vitro diagnostic sectors for more than 23 years with Eli Lilly, Roche Pharma R&D Center, Sanofi, Beckman Coulter, Medtronic, and Johnson & Johnson. Prior to that, Yin served as a hospital pharmacist for about three years. She is an active member of professional societies, including EUCCC HCE working group, AdvaMed, AHWP, the China Society for Drug Regulation (CSDR), the China Association of Medical Device Industry (CAMDI), and the Shanghai BME Association.

Sharon Cai

Sharon Cai, Sr. Regulatory Director, Roche Diagnostics, Shanghai Ltd.

Sharon Cai has more than 19 years of successful experience in the pharmaceutical, biological products, medical device, and in vitro diagnostic (IVD) products regulatory field. Cai currently is a committee member of STA/TC338, and a member of the biological IVD group of the China Medicinal Biotech Association. She holds a master’s degree in cell biology.


Additional speakers to be added.


Cancellations

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

To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.


Questions

For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshophttps://www.raps.org/website/virtual-event-help

For account support, contact the RAPS Support Center: +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

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