C&GT Regulation

University Assigned Professor Module: Prof. A Spyridonidis

 

The basic principles of statistical analysis will be presented and their applications to C&GT 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