Spring Intro 2023

Jenny Lamport

Data content of MAA

Efficacy Clinical

Quality Chemistry & Pharmacy

Safety Preclinical

The Organisation for Professionals in Regulatory Affairs

9

The CTD format

Common technical document ● ICH guideline M4 ● Common presentation format for EU, Japan, USA – Also adopted by other countries ● 5 modules

The Organisation for Professionals in Regulatory Affairs

10

5