Navigating Global Regulations: How Strategic CDx Approvals Empower Pharma Partnerships

As precision medicine expands globally, navigating the complex regulatory landscape for companion diagnostics (CDx) has become critical for successful pharma partnerships. This webinar brings together regulatory experts from Burning Rock and Riken Genesis to share real-world strategies for achieving multi-regional CDx approvals.

Jenny Cao will outline key considerations for aligning CDx development with FDA, EMA, and NMPA requirements, highlighting approaches to mitigate risks across different jurisdictions. Topics include early-stage development planning, differences in registration pathways across major markets, and strategies to help pharma partners reduce multi-regional regulatory risks.

Yoko Shiroki will then present a detailed case study on the recent Japanese approval of OncoScreen Plus as a CDx for AstraZeneca's capivasertib. She will share insights into PMDA expectations for imported CDx products, submission milestones, communication strategies, and the collaborative mechanism among Burning Rock, Riken Genesis, and AstraZeneca throughout the registration process..

Attendees will gain practical knowledge to streamline global registration pathways and strengthen partnerships with pharmaceutical companies.

Learning Objectives
Upon attending, participants will be able to:

• Compare regulatory requirements and approval pathways for CDx in the US, EU, China, and Japan.
• Identify early-stage development strategies to facilitate alignment with multiple regulatory agencies.
• Navigate key milestones and communication strategies for successful PMDA submissions of imported CDx products.
• Apply best practices for cross-sector collaboration between diagnostic companies and pharma partners to expedite global approvals.