Module 9 2021

Take away messages

ATMPs complexity, diversity and fast pace development ● Tailored approach to quality, non-clinical and clinical development development ● Guideline are generic, often mutuated from biologicals or lacking in specific areas and non-harmonized ● Derogation based on scientific background and risk assessment ● Non overlapping criteria for Dossier assessment ATMPs stem from science, understanding of basic scientific principle is needed for regulators also Development of ATMPs requires an integrated approach: quality, non-clinical and clinical and Regulators require constant and seamless interaction

Novartis Pharma AG- Business use only- not for further distribution

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