Understanding Regulations in China, Japan and India for Device Expansion and Clinical Operations Excellence

​Join us as we explore the advantages and intricacies of setting up a clinical study in China, India, and Japan, especially for clients based in Europe and North America. Learn about the recommended pathways for market access and approval needs based on practical case studies. We will provide an overview of the regulatory landscape and key considerations for setting up a trial in those countries whether you are seeking your first market approval or looking to expand your market access in the region. ​This webinar is free to attend.

Learning Objectives

Learn how to navigate product expansion and approval in China, India, and Japan with a CE mark and FDA approval when considering:​

• Device classifications and pathways​
• Market approval needs​
• Scale of trial (local or global)​

Learn how to set up a clinical study in China, India, and Japan to pursue first-time market approval with a focus on:

• Cost of patient care (impacts to studies)​
• Market Launch needs through post market [clinical data needs/PMS] (pre or post market value)​
• Insurance requirements​
• New regulations​

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Presented by

Speakers

Bingjia Chen
Senior Business Development Manager
IQVIA Medtech, China

Sneha Gupta
Associate Director Regulatory Affairs
IQVIA Medtech, Indi

Kirti Narang
Senior Clinical Project Manager
IQVIA Medtech India

Kazuaki Sekiguchi, Ph.D
Senior Clinical Strategy Director
IQVIA Medtech & BioTech, Japan & Asia Paciifc