Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Masterclass

Devices and ATMPs – examples and challenges

7 December 2023

Shaun Stapleton, VP Regulatory Affairs, Amryt Pharma

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

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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

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