Real World Evidence (RWE) in Japan

Project Description  

This project focuses on sharing real-world evidence (RWE) use cases relevant to the Japanese regulatory and industry context, including applications in accelerating drug development, post-marketing surveillance (PMS), and preventative healthcare strategies. 

There is currently a significant gap in awareness, understanding and practical experience with RWE among pharmaceutical professionals in Japan. This initiative aims to address that gap by creating opportunities to share practical, region-specific examples aligned with Japanese regulatory requirements and expectations. By highlighting relevant use cases, the project will support stakeholders in better understanding how RWE can be effectively applied across the product lifecycle. It will also promote knowledge exchange and encourage more consistent and informed use of RWE within Japan. Ultimately, this work will help build capability, improve decision-making, and strengthen the integration of RWE into regulatory and industry practices. 

Yasunari Sadatsuki, AstraZeneca

(Co-Lead) Yosuke Nishida, PwC

(Co-Lead) William Kuan, SAS

yasunari.sadatsuki@astrazeneca.com

Nicola Newton, PHUSE Project Coordinator

nicky@phuse.global