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Date/Time
Date(s) - 03/14/2019
9:00 am - 3:30 pm GMT

Location
Hilton Milton Keynes

Categories

NAMSA is proud to present this new one-day summit dedicated to Chinese medical device market access. This summit will provide a unique opportunity for medical device manufacturers to learn directly from NAMSA’s regulatory and clinical experts whom are focused on development efforts in China. This small, intimate gathering will offer attendees with recommendations, updates and resources critical to addressing China’s commercial and market access complexities. Throughout the day’s presentations, real-world development examples will be shared to understand lessons learned; time will also be allotted to network and ask questions of NAMSA’s experts.

Cost: $150.00
(Lunch will be provided)

Agenda

09:00 – 09:30 Registration
09:30 – 09:45 Welcome / Introduction
Fiona Robbins; NAMSA Account Manager (UK) 
09:45 – 10:45 Understanding China’s NMPA (CFDA) Regulatory Environment: Suggested Strategies for Success
Cindy Hu; NAMSA Director of Regulatory Consulting (APAC)
10:45 – 11:00 Networking
11:00 – 12:00 How to Conduct Medical Device Clinical Studies in China
Thomas Jaw; NAMSA Clinical Director (APAC) 
12:00 – 13:00  Lunch
13:00 – 14:00 Acceptance of Foreign Clinical Data in China
Thomas Jaw; NAMSA Clinical Director (APAC) 
14:00 – 14:15  Break
14:15 – 15:00 Challenges to Leverage EU CER to NMPA Submission and Suggestion
Cindy Hu; NAMSA Director of Regulatory Consulting (APAC)
15:00 – 15:30  Conclusion / Q&A

 

Meet the Speakers:


Cindy Hu; Director of Regulatory Consulting, NAMSA Asia Pacific
Cindy Hu has broad experiences in medical device industry in China, including regulatory, quality and medical writing in various therapeutic area. Cindy and her consulting team provided consultation to numerous global medical device manufacturers on NMPA regulatory affairs including creating strategic plans, registration & filing, clinical evaluations and post market supports under the NMPA new regulations. Before NAMSA, Cindy had been working for Stryker China, GE Healthcare China and Fenwal Inc. with leadership roles in Regulatory Affairs and Quality Assurance. Cindy got her BS degree in Electrical-Mechanical Control and Detection from Beijing University of Aeronautics and Astronautics.

 


Dr. Thomas Jaw, PhD; Clinical Director APAC, NAMSA
Dr. Thomas Jaw has a Ph. D degree in Genetics and worked on drug screening, built disease model and pharmacology studies. He has over 12 year industrial experience in from preclinical, first-in-human and post-market clinical studies for pharmaceutical and medical device registration in NMPA, US FDA, EMA and TFDA. He has a broad spectrum experience in the clinical study of cardiovascular, rhinoplasty, orthopedic, dental care, oncology,  dermatology diseases.

 

Who Should Attend?

  • Clinical Affairs Specialist, Manager or Director
  • Product Development
  • Research & Development
  • CEO
  • Regulatory Affairs Specialist, Managers, Director
  • Quality Assurance Specialist, Managers, or Director
  • Clinical Operations
  • Clinical Project Management
  • Sterilization Specialists
  • Sterility Assurance Managers
  • Validation Engineers
  • Microbiologists
  • Packaging Engineers
  • Design Engineers

 

Event Details

Reservations are closed for this event.