Jörg Engelbergs
Scientific-Regulatory Assessor Targeted & Personalized Biomedicines Paul-Ehrlich-Institut, National Competent Authority for Medicinal Products & CDx Devices
Jörg Engelbergs is currently working for the Paul-Ehrlich-Institut (PEI), German National Competent Authority for Medicinal Products and CDx devices, 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 CTR conformity of clinical trials and IVDR conformity of associated CDx performance studies. He is also responsible for the technical, procedural and scientific implementation of the new responsibility of PEI for CDx performance studies. At the European level 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 scientific project leader in cancer research at the West German Cancer Center (WTZE) and in neuropharmacology research, including R&D of diagnostic/predictive biomarkers and assays, as well as in the establishment and management of a central clinical genotyping service center at the Medical Faculty of the University of Essen, Germany.
Seminars
- How has IVDR changed expectations for evidence generation, documentation, and timelines across regulators, notified bodies, pharma, and diagnostic developers?
- At what stage should pharma and diagnostic partners meaningfully engage notified bodies and regulators to ensure an aligned CDx development pathway? And what does effective early alignment look like?
- What are the most common bottlenecks companies encounter during IVDR certification, and what practical steps or partnership models are proving successful in navigating them?
- 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
