Mastering GMO & Companion CDx Trials: The EU Regulatory Playbook

Access to companion diagnostics (CDx) remains limited in the EU, especially for rare and neurological diseases—despite their critical role in precision medicine. Biotech and specialty pharma companies conducting gene-modified organism (GMO) trials in Europe must contend with complex regulatory and operational hurdles when incorporating CDx components.

This expert-led webinar, featuring Mesfin James (VP, Head of Regulatory Affairs) and Lakshmi Guduri (Senior Director, Project Management), offers strategic and operational guidance for navigating these challenges. The presenters provide a clear understanding of current EU regulations for GMO trials with CDx, submission strategies for compliance, and best practices for site readiness and logistics. Tailored for regulatory and clinical teams, the session also includes key insights for U.S.-based sponsors operating in Europe.