Module 18 2021

Learning Outcomes: Recap

 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 understand the wide range of combined ATMP products being developed  To be able to look at specific examples and correctly classify them in the EU and US  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 TOPRA MSc Module 18: Drug Device Combinations and other Technology