This course will introduce the students the specific legal landscape that applies to ATMP’s in Europe.
- Oddělení celoživotního vzdělávání – Děkanát – Správní pracoviště – Lékařská fakulta
Osnova
- The course will cover and discuss the following topics:
- • Regulatory distinctions between ATMPs and other types of products in the life science domain, e.g. SOHOs, Biologics
- • Overlaps between different regulatory regimes for ATMP’s (e.g. regulation of GMO and SOHO)
- • Complementarity and potential tensions between national and EU regulation (e.g. on ethical issues and HTA)
- • Special challenges ATMP’s are facing compared to other medicinal products