Co-Development of Biomarker Guided Medicines, Corresponding Assays & CDx in the EU – A Scientific- Regulatory Update from the Medicine’s Perspective

• News on the European regulatory framework for biomarker-guided medicines and CDx
• Current experiences and challenges to streamline co-development
• Updates from the EU COMBINE Project

Speakers:

Jörg Engelbergs

Scientific-Regulatory Assessor Targeted & Personalized Biomedicines

Paul-Ehrlich-Institut, National Competent Authority for Medicinal Products & CDx Devices

Hilke Zander

Clinical Assessor

Paul-Ehrlich-Institut, National Competent Authority for Medicinal Products & CDx Devices