Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Key challenges with ATMPs and combined ATMPs

• Tumourigenicity risk • Migration of cells from target • Device aspects to cover essential requirements • Compatibility with cells

TOPRA MSc Module 18: Drug Device Combinations and other Technology

41

Learning Outcomes

 To understand the interfaces between devices, human tissue products and ATMPs in the EU and US  To describe the types of product defined as ATMPs in the EU and US  To understand the concept of a “combined ATMP” in Europe  To be aware of the classification procedure available through EMA  To be able to look at specific examples and correctly classify them  To be aware of differences in approach between EU and US  To understand some of the main challenges presented in the development of combined ATMPs

42

21