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Matthias Renner | Fleming
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Matthias Renner

Head of Section Quality of Coagulation Products and Gene Therapy Senior Scientific Assessor for quality aspects of ATMPs
Paul-Ehrlich-Institut (PEI), Germany
Matthias Renner is Head of Section “Assessment Quality of Coagulation Products and Gene Therapy“ in the Department of Hematology, Cell and Gene Therapy and Senior Scientific Assessor for quality of ATMPs at the Paul-Ehrlich-Institut (PEI), the German Federal Institute for the regulation of Vaccines and Biomedicines. In his work Matthias is involved in the evaluation of clinical trial applications and national scientific advice procedures for ATMPs and serves as scientific consultant in GMP-inspections of Gene Therapy Medicinal Products.
Since 2009 he is expert to the European Medicines Agency (EMA) for the assessment of marketing authorisation applications, for scientific advices and other EMA procedures. He is Member of the EDQM Gene Therapy Working Group and of the Cell and Gene Therapy Committee of the International Alliance for Biological Standardization. From 2016 to 2023, Matthias was German Alternate to the CHMP Biologics Working Party.
Until he joined the PEI, he worked in several positions on the development of cell and gene therapies in the biotech industry. Matthias holds a Ph.D. and a lecturer´s degree in Virology.

Events/Masterclasses Matthias Renner is currently speaking at

Pharma

Cell & Gene Therapy Products – CMC & Quality Requirements
19 – 21 September 2023
NH Danube City, Vienna, Austria | Online Live Stream | 9:00 CEST – 15:00 CEST
This unique course provides a practical & in-depth understanding of CMC & quality requirements and brings clarifications on global regulation, requirements, compliance & quality concerns.
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Linkedin
Matthias Renner
Head of Section Quality of Coagulation Products and Gene Therapy Senior Scientific Assessor for quality aspects of ATMPs
Paul-Ehrlich-Institut (PEI), Germany
Matthias Renner is Head of Section “Assessment Quality of Coagulation Products and Gene Therapy“ in the Department of Hematology, Cell and Gene Therapy and Senior Scientific Assessor for quality of ATMPs at the Paul-Ehrlich-Institut (PEI), the German Federal Institute for the regulation of Vaccines and Biomedicines. In his work Matthias is involved in the evaluation of clinical trial applications and national scientific advice procedures for ATMPs and serves as scientific consultant in GMP-inspections of Gene Therapy Medicinal Products.
Since 2009 he is expert to the European Medicines Agency (EMA) for the assessment of marketing authorisation applications, for scientific advices and other EMA procedures. He is Member of the EDQM Gene Therapy Working Group and of the Cell and Gene Therapy Committee of the International Alliance for Biological Standardization. From 2016 to 2023, Matthias was German Alternate to the CHMP Biologics Working Party.
Until he joined the PEI, he worked in several positions on the development of cell and gene therapies in the biotech industry. Matthias holds a Ph.D. and a lecturer´s degree in Virology.
Matthias Renner
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