Navigating Japan’s Regulatory Challenges in CDx Development from A Pharmaceutical Company Perspective: Practical Solutions & Future Directions

• Current situation and challenges of Japan’s regulatory environment for CDx development compare to US/EU
• Case study of alternative diagnostic development based on these challenges
• Proposals for regulatory environment to advance future companion diagnostics development

Speakers:

Takaharu Hino

Senior Director, Regulatory Strategy & Policy, Oncology, Regulatory Affairs Division, R&D

AstraZeneca