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Jörg Engelbergs | Speaker | Fleming
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Dr. Jörg Engelbergs

Paul Ehrlich Institute (PEI), Germany
Jörg Engelbergs is working for the Paul-Ehrlich-Institut (PEI, German National Competent Agency for Medicines & CDx) as a regulatory-scientific assessor for biopharmaceuticals with focus on targeted & predictive biomarker restricted personalized biomedicines (Quality/Analytics, Non-Clinic, Biomarkers, CDx). He is involved in the European process of marketing authorization and medicine’s life cycle comprising scientific assessments and advices. Further tasks encompass scientific advices and assessments for European CDx consultation procedures, and national clinical trial and correlated CDx performance study applications.
He is member of several CDx related European working groups, e.g. EMA Methodology Working Party (MWP), EMA SIA PGx, EMA ESEC Oncology, EMA CHMP/CAT CDx Expert Group (co-chair), EU Combine Project, EMA MWP drafting group for a new guideline on predictive biomarker-assay development. Further he is responsible for the national implementation of the new 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 with focus on R&D of diagnostic and predictive biomarkers and correlated assays (Omics).

Events/Masterclasses Dr. Jörg Engelbergs is currently speaking at

Pharma

Stability & Shelf Life of Biologics
17 – 18 September 2025
Barcelona, Spain | 9:00 CEST - 17:30 CEST
The purpose of this Stability & Shelf Life of Biologics Training Course is to get comprehensive overview on stability and shelf-life regulatory landscape.
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Pharma

Companion Diagnostics (CDx) - Navigating the Regulatory Challenges
11 – 12 June 2025
Vienna, Austria
The implementation of the EU In Vitro Diagnostic Device Regulation 2017/746 (IVDR) has introduced new processes for the authorization of performance studies and conformity assessment of companion diagnostic devices (CDx) in Europe.
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Pharma

Quality Requirements for Biotech Products
Online Live Stream
This practical course provides an in-depth understanding regulatory landscape for national CTA procedures.
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Dr. Jörg Engelbergs
Job
Paul Ehrlich Institute (PEI), Germany
Jörg Engelbergs is working for the Paul-Ehrlich-Institut (PEI, German National Competent Agency for Medicines & CDx) as a regulatory-scientific assessor for biopharmaceuticals with focus on targeted & predictive biomarker restricted personalized biomedicines (Quality/Analytics, Non-Clinic, Biomarkers, CDx). He is involved in the European process of marketing authorization and medicine’s life cycle comprising scientific assessments and advices. Further tasks encompass scientific advices and assessments for European CDx consultation procedures, and national clinical trial and correlated CDx performance study applications.
He is member of several CDx related European working groups, e.g. EMA Methodology Working Party (MWP), EMA SIA PGx, EMA ESEC Oncology, EMA CHMP/CAT CDx Expert Group (co-chair), EU Combine Project, EMA MWP drafting group for a new guideline on predictive biomarker-assay development. Further he is responsible for the national implementation of the new 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 with focus on R&D of diagnostic and predictive biomarkers and correlated assays (Omics).
Dr. Jörg Engelbergs
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