What’s important to know about real-world evidence data collection in Germany?
In this post, I’ll summarise the key points on the real-world evidence data collection in Germany, that the G-BA can request since
Tag: cell and gene therapy
Which quality requirements apply to ATMPs in Germany?
Welcome to the second post in the quality assurance series, focusing on the hot topic of ATMPs! Next week, I’ll be focusing
The G-BA specifies QA requirements for cell and gene therapies in Germany
In the previous assessments of Kymriah, Yescarta, Tecartus, and Zolgensma, the G-BA had defined specific QA requirements for the use of these
G-BA assessment of orphan drug gene therapies, Zolgensma and Libmeldy
The gene therapies Zolgensma and Libmeldy, both, are targeting very rare, severe, genetic diseases in children. The G-BA has now assessed the
G-BA assessment of CAR-T therapy Tecartus
The G-BA has now completed its benefit assessment of the CAR-T therapy, Tecartus, which is indicated for the treatment of mantle cell