Spring Intro 2023

03/03/2023

The Learning Objectives for this presentation were: • Module 4 of the Common Technical Dossier • Nonclinical elements of Module 2 – the Nonclinical Overview and the Nonclinical

written and tabular summaries • Nonclinical input into the SmPC • Nonclinical Regulatory Guidelines • Nonclinical Dossier Review at the MHRA

• Highlight Important Regulatory aspects (MAA vs. CTA) • Consider problem areas and how to resolve them

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