Jörg Engelbergs is working for the Paul-Ehrlich-Institut (PEI, German National Competent Agency for Biomedicines) as a regulatory-scientific assessor for biopharmaceuticals with focus on targeted and predictive biomarker guided personalized biomedicines (Quality/CMC, Non-Clinic, Clinical Biomarkers, Companion Diagnostics).
He is involved in the European process of marketing authorization, including CDx consultation procedures, and medicine’s life cycle comprising scientific assessments and advices. Further tasks encompass scientific assessments for clinical trial and correlated CDx performance study applications. He further contributes to national and third-country (USA/Asia) GMP inspections.
Jörg is member of several European working groups, including EMA Methodology Working Party, EMA SIA PGx (leadership team), EMA Companion Diagnostics Expert Group (co-chair), EU Combine Project and EDQM working groups. Further he is responsible for the national implementation of the new scientific-regulatory processes for CDx performance studies at PEI.
Jörg holds a Diploma in biology and a PhD in cell biology and biotechnology. Before joining the PEI, he has gained large experience as project leader in experimental cancer and neuropharmacology research, as well as lead of a clinical core facility for Monoclonal Antibody Research and Production.
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Jörg Engelbergs is working for the Paul-Ehrlich-Institut (PEI, German National Competent Agency for Biomedicines) as a regulatory-scientific assessor for biopharmaceuticals with focus on targeted and predictive biomarker guided personalized biomedicines (Quality/CMC, Non-Clinic, Clinical Biomarkers, Companion Diagnostics).
He is involved in the European process of marketing authorization, including CDx consultation procedures, and medicine’s life cycle comprising scientific assessments and advices. Further tasks encompass scientific assessments for clinical trial and correlated CDx performance study applications. He further contributes to national and third-country (USA/Asia) GMP inspections.
Jörg is member of several European working groups, including EMA Methodology Working Party, EMA SIA PGx (leadership team), EMA Companion Diagnostics Expert Group (co-chair), EU Combine Project and EDQM working groups. Further he is responsible for the national implementation of the new scientific-regulatory processes for CDx performance studies at PEI.
Jörg holds a Diploma in biology and a PhD in cell biology and biotechnology. Before joining the PEI, he has gained large experience as project leader in experimental cancer and neuropharmacology research, as well as lead of a clinical core facility for Monoclonal Antibody Research and Production.
