Module 9 2021

In this presentation we will cover

Introduction to ATMPs ● What is an ATMP? ● Which are the main differences between ATMPs and large molecules? ● Which is the current trend for ATMPs? How can ATMPs be classified and divided? Regulatory aspects for ATMPs ● How are ATMPs regulated? ● Are there differences in regulation in EU and US? ● Which is the lesson learned so far and any room for improvements? Developing ATMPs and the CTD format ● How can a Module 3 (CMC) be structured and prepared? ● How peculiarities of the ATMPs impact on the CMC Section of the CTD? ● Which studies are relevant for Module 4? ● Clinical development To wrap up: which are the challenges in ATMP development? Learning Outcome and leaving messages

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