Jörg is currently working for the Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, as regulatory-scientific expert and assessor (pharmaceutical quality and non-clinic) for antibody based therapeutics, as well as for biomarkers and companion diagnostics as part of personalized medicines. He is involved in the European process of authorization of biopharmaceuticals, comprising scientific assessments and advices. Further activities are assessments of GCP conformity of clinical phase I-III trials and both national and third-country (USA / Asia) GMP inspections. s. For EDQM he is acting as expert in the Host-Cell Protein Working Party and in the P4Bio (Biosimilar) Working Party and for EMA he is acting as member in the Pharmacogenomics Working Party and in the new Companion Diagnostic Consultation Working Group. He has been also co-author of the EMA guideline on production and quality control of monoclonal antibodies and related substances. Jörg holds a Diploma in biology and a PhD (cell biology). Before he joined the PEI, Jörg has gained large experience in experimental cancer and neuropharmacology research with focus on targeted monoclonal antibody and biomarker based personalized biomedicines. In this time he was head of “Neuropharmacology laboratory” and in parallel head of clinical core “Genotyping service center” at Department of Neurology at University of Essen Medical School. Before, he has been scientific project leader in various cancer research projects and in parallel head of the core “Monoclonal antibody research and production unit” at the Institute of Cell Biology at the West German Cancer Center.
Events/Masterclasses Dr. Jörg Engelbergs is currently speaking at
Pharma
Stability & Shelf Life of Biologics
17 – 19 September 2024
Barcelona, Spain | Online Live Stream | 9:00 CEST -15:00 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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Jörg is currently working for the Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, as regulatory-scientific expert and assessor (pharmaceutical quality and non-clinic) for antibody based therapeutics, as well as for biomarkers and companion diagnostics as part of personalized medicines. He is involved in the European process of authorization of biopharmaceuticals, comprising scientific assessments and advices. Further activities are assessments of GCP conformity of clinical phase I-III trials and both national and third-country (USA / Asia) GMP inspections. s. For EDQM he is acting as expert in the Host-Cell Protein Working Party and in the P4Bio (Biosimilar) Working Party and for EMA he is acting as member in the Pharmacogenomics Working Party and in the new Companion Diagnostic Consultation Working Group. He has been also co-author of the EMA guideline on production and quality control of monoclonal antibodies and related substances. Jörg holds a Diploma in biology and a PhD (cell biology). Before he joined the PEI, Jörg has gained large experience in experimental cancer and neuropharmacology research with focus on targeted monoclonal antibody and biomarker based personalized biomedicines. In this time he was head of "Neuropharmacology laboratory" and in parallel head of clinical core “Genotyping service center" at Department of Neurology at University of Essen Medical School. Before, he has been scientific project leader in various cancer research projects and in parallel head of the core "Monoclonal antibody research and production unit" at the Institute of Cell Biology at the West German Cancer Center.
