C> Regulation
University Assigned Professor Module: Prof. A Spyridonidis
The basic principles of statistical analysis will be presented and their applications to C> therapeutic products
“The regulatory authorities (FDA, EMA) and the regulatory review pathways (IND to BLA; IMPD to MAA)”
ATMP (EU) legislation – an overview
CGT (FDA) guidance – an overview
Cell & Gene Therapy Quality/ CMC considerations
SEC / ISBT 128 and other labeling systems
Hospital Exemption Use
Submitting a file for Cell Production authorization
“Expedited programs
and orphan drug issues”
Case study
