Navigating Clinical Trials in Japan: From Regulatory Strategy to Operational Success

07:00 IST (New Delhi) / 09:30 a.m. CST (Beijing) / 10:30 a.m. JST (Seoul, Tokyo) /12:30 AEDT (Sydney) / 21:30 p.m. EDT (Boston - Monday, March 24)07:00 IST (New Delhi) / 09:30 a.m. CST (Beijing) / 10:30 a.m. JST (Seoul, Tokyo) /12:30 AEDT (Sydney) / 21:30 p.m. EDT (Boston - Monday, March 24)

Duration: 90 minutes

In today's dynamic global pharmaceutical landscape, understanding Japan's regulatory environment and clinical development processes is essential. This virtual session explores effective strategies for drug development in Japan, including its growing role in global Phase III studies and best practices for PMDA interactions. We'll examine unique aspects of conducting clinical trials in Japan, addressing challenges and solutions. Through case studies and insights, participants will learn to navigate Japan's regulatory landscape and optimize clinical development in this important market.

This webinar will cover:

Navigating Japan's Regulatory Landscape

• Key regulatory bodies: PMDA and MHLW
• Evolving regulatory strategies for drug development
• Japan's expanding role in global Phase III studies
• Best practices for PMDA interactions
• Recent regulatory changes and future trends
• Achieving Operational Excellence in Japanese Clinical Trials

Unique aspects of conducting trials in Japan

• Bridging ICH GCP and Japan ICH GCP
• Overcoming challenges in site management and recruitment
• Streamlining IRB application processes
• Enhancing CRA effectiveness

Featured Case Studies:

• Successful integration of Japan in a global Phase III study
• Overcoming operational challenges in a recent Japanese trial