Performing Clinical Trials for ATMPs

Description

Basic pricipals of clinical trials, factors to consider for designing a successful ATMP-based clinical trials

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Like other drugs, you need to prove that the administration of your ATMP is safe and effective for the patient, and so you need to conduct clinical trials specific to your ATMP. To do this, you follow the same processes, procedures, regulations and so on as clinical trials with other drugs, but on top of that you will encounter additional challenges and have to follow additional regulations. This module will discuss some basic principles of clinical trials, the regulatory framework, the different phases of a clinical trial and the roles and responsibilities of different stakeholders and, where appropriate, focus on the specificities of ATMP clinical trials.

Performing Clinical Trials for ATMPS