Spring Intro 2023

03/03/2023

TOPRA Introductory Course 2023

The Components of the Non-Clinical Section of a Marketing Authorisation Application and a Clinical Trial Authorisation Application – Views of a Former Regulatory Assessor

David R Jones, Pharmaco-Toxicology Consultant davidrjones@hotmail.co.uk

ENABLINGAND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

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The Learning Objectives for this presentation are: • 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 • Nonclinical Part of CTA

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

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