Navigating EU Regulations for GMO Trials with Companion Diagnostics

In the evolving landscape of precision medicine, one critical gap persists: limited patient access to companion diagnostic (CDx) tests—especially for rare and neurological diseases. While biomarker testing plays a vital role in guiding targeted therapies, significant regulatory and operational challenges remain, particularly in the European Union.

This expert-led webinar is essential for biotech and specialty pharma companies planning GMO (gene-modified organism) trials that include CDx components in Europe. Gain the insights you need to confidently navigate complex EU requirements and ensure successful trial planning and execution from Mesfin James (Vice President, Head of Regulatory Affairs) and Lakshmi Guduri (Senior Director, Project Management).

In this webinar, you’ll learn:

• The latest EU regulatory requirements for GMO trials involving companion diagnostics
• Strategic guidance to streamline submission processes and achieve compliance
• Operational best practices—from site readiness to logistics—to support trial execution
• Considerations and tips for US-based sponsors running GMO trials in Europe

Designed for regulatory and clinical leaders, this session offers actionable strategies backed by real-world examples and case studies—helping you avoid delays, reduce risk, and improve trial outcomes.

Fill out the form to watch the webinar and gain key insights into running successful GMO trials with CDx in the EU.