Autumn Introductory Course 2018 - Day 2 Handouts

24/10/2018

2.7 Clinical Summary

The Learning Objectives for this presentation were:

● Factual summary of studies ● 2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods ● 2.7.2 Summary of Clinical Pharmacology Studies

• Structure of Module 2

• Differences between overviews and summaries

● 2.7.3 Summary of Clinical Efficacy ● 2.7.4 Summary of Clinical Safety ● 2.7.5 References ● 2.7.6 Synopses of individual studies (ICH E3)

• Details of each section

• Consistency and links between documents

Usually in the range of 50 to 400 pages

• All data supports details in the SmPC

THANK YOU FOR YOUR ATTENTION

• Questions?

48

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