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 and serves Member of this group since 2023.
Before he joined the PEI, he worked in several positions in biotech industry on the development of cell and gene therapies. Matthias holds a Ph.D. and a lecturer´s degree in Virology.
Events/Masterclasses Matthias Renner is currently speaking at
With the increasing complexity of new cell & gene therapies, as well as a rapid growth of these products in the development, unique challenges have emerged especially in the area of manufacturing and control.
Stability & Shelf Life of Cell & Gene Therapy Products
Online Live Stream
This 2-day practical workshop is focused on ATMPs & brings a comprehensive overview on stability and shelf-life regulatory landscape, as well as analytical methods for stability assessment of your cell & gene therapy products.
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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 and serves Member of this group since 2023.
Before he joined the PEI, he worked in several positions in biotech industry on the development of cell and gene therapies. Matthias holds a Ph.D. and a lecturer´s degree in Virology.
