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Matthias Renner | Fleming
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Matthias Renner

Head of Section Non-viral Gene Transfer Medicinal Products, Senior Scientific Assessor for quality and non-clinical aspects of ATMPs
Paul-Ehrlich-Institut (PEI), Germany
Matthias Renner is Acting Head of Section “Non-viral Gene Transfer Medicinal Products” 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 was member of the EMA CAT Gene Therapy Working Party since 2010, and its vice chair since 2011. He is Member of the Cell and Gene Therapy Committee of the International Alliance for Biological Standardization and since 2016 German Alternate to the CHMP Biologics Working Party.

Events/Masterclasses Matthias Renner is currently speaking at

Pharma

Stability & Shelf Life of Cell & Gene Therapy Products
28 - 29 March 2023
Hotel Rathauspark Wien, Austria | Online Live Stream | 9:00 CEST – 16:00 CEST
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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Pharma

Cell & Gene Therapy Products – CMC & Quality Requirements
13 - 15 September 2022
NH Sants Barcelona, Spain | Online Live Stream 09:00 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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Matthias Renner
Head of Section Non-viral Gene Transfer Medicinal Products, Senior Scientific Assessor for quality and non-clinical aspects of ATMPs
Paul-Ehrlich-Institut (PEI), Germany
Matthias Renner is Acting Head of Section “Non-viral Gene Transfer Medicinal Products” 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 was member of the EMA CAT Gene Therapy Working Party since 2010, and its vice chair since 2011. He is Member of the Cell and Gene Therapy Committee of the International Alliance for Biological Standardization and since 2016 German Alternate to the CHMP Biologics Working Party.
Matthias Renner
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