Jörg Engelbergs

Scientific-Regulatory Expert Targeted & Personalized Biomedicines at Paul-Ehrlich-Institut

Speaker

Jörg Engelbergs is currently working for the Paul-Ehrlich-Institut (PEI), National Competent Authority for Medicines and CDx, in Germany as a scientific-regulatory assessor (Quality, Non-Clinic, Biomarkers, CDx). He is involved in the European process of marketing authorization and life cycle of predictive biomarker guided biopharmaceuticals comprising scientific assessments and advices. Further tasks are assessments of GCP conformity of clinical trials and IVDR conformity of associated CDx performance studies. He is responsible for the technical, procedural and scientific implementation of the new responsibility of PEI for CDx performance studies. Further, he is member of several CDx related European working groups, e.g. EMA CHMP/CAT CDx Expert Group (Co-Chair), EMA Methodology Working Party, EMA SIA PGx (Leadership Team), and EU COMBINE Project.

He holds a Diploma in biology and a PhD. He has extensive experience as a scientific project leader in cancer research and neuropharmacological research, including R&D of predictive biomarkers and assays, as well as in the establishment and management of a central clinical genotyping service center (SNP, expression profiling; focus Neurology) at the Medical Faculty of the University of Essen.