C> Regulation

University Assigned Professor Module: Prof. A Spyridonidis

 

The students will gain knowledge about the US, EU and local regulations of cell and gene therapies. They will be exposed to applicable laws, regulations and guidelines for best practice

 

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

Medical device regulations PMA/MDR

Expedited programs, orphan drug and Hospital Exemption

Submitting a file for Cell Production authorization

Real World Data

Case study