Advanced Therapy Medicinal Products (ATMPs) constitute a highly innovative and scientifically complex class of medicinal products, comprising gene therapy medicinal products, somatic cell therapy medicinal products, tissue-engineered products, and combined ATMPs. These therapies offer considerable potential for the treatment, modification, or possible cure of severe, inherited, and otherwise intractable diseases. However, their intrinsic biological complexity, product heterogeneity, and often individualised manufacturing approaches pose substantial scientific, regulatory, and quality-related challenges throughout development and lifecycle management.
In this webinar, Asphalion expert Beatriz Aldaz, will discuss the main quality concerns and challenges associated with ATMPs, review the current European legal framework governing these products, and describe the evolving European legislation relevant to ATMPs.
📅 17 September- 3:00 p.m. (CEST)
🔗 Register now and save your spot: https://bit.ly/4wDg2mt
Contact us for further information: [email protected]
