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MedTech Summit

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10 - 14 June 2024
DoubleTree by Hilton Brussels CityBrussels, Belgium (Hybrid Event)

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

Profile

Jörg Engelbergs is currently working for the Paul-Ehrlich-Institut (National Competent Authority for Medicines and CDx) in Germany as regulatory-scientific expert and assessor (Quality, Non-Clinic, Biomarkers, Companion Diagnostics) for biopharmaceuticals. He is involved in the European process of marketing authorization of biopharmaceuticals (focus on targeted biomarker guided medicines) comprising scientific assessments and advices. Further activities are assessments of GCP conformity of clinical trials and IVDR conformity of CDx performance studies. He is member of several European expert groups, e.g. EMA Methodology Working Party, EMA CHMP/CAT CDx Expert Group (Co-Chair), EMA Oncology ESEC or EC COMBINE Project. He holds a Diploma in biology and a PhD in cell biology / biotechnology (cancer research).

Agenda Sessions

  • Multi-Stakeholder Discussion: Certifying Companion Diagnostics (CDx)

    14:45