ATMPs for Cancer Immunotherapy: A Regulatory Overview
2016
This chapter discusses European regulatory requirements for development of advanced therapy medicinal products (ATMP) for cancer immunotherapy approaches, describing the framework for clinical trials and for marketing authorization.Regulatory critical issues and challenges for developing ATMP are also discussed, with focus on potency determination, long-term follow-up, comparability, and insertional mutagenesis issues. Some of the most critical features of GMP application to ATMP are also described.
Keywords:
- Correction
- Source
- Cite
- Save
- Machine Reading By IdeaReader
5
References
5
Citations
NaN
KQI