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QUALITY ASPECTS FOR AN ATMP (M3 OF MAA)
Session Chair(s)
Valerie Catherine Pimpaneau, PHD
Senior Director
Voisin Consulting Life Sciences, France
The Challenges of Potency Assay Development of Cell and Gene Therapy Product
Learning Objective : This presentation will provide an overview of potency assay development strategies throughout development and highlight the challenges inherent to the complexity of Cell and Gene Therapy Product. Provide an overview of EU and US expectations
Speaker(s)
Major Quality Issues for CBMPs
Margarida Menezes Ferreira, PHD
Infarmed, Portugal
Scientific Advice Coordinator and Senior Assessor
The Challenges of Potency Assay Development of Cell and Gene Therapy Product
Valerie Catherine Pimpaneau, PHD
Voisin Consulting Life Sciences, France
Senior Director
New Developments for GTMPs
Bastien Calmels, PHARMD, PHD
Transgene, France
Quality Control Senior Manager