e-Learning: CTD Module 3 - Data requirements in the EU

- CTD structure and applicable guidelines - Drug substance Part - ASMF and CEP - Drug product partThis e-Learning programme will familiarise you with the data requirements in CTD Module 3.LernzieleModule 3 is an essential part of the CTD. It presents data on the quality of the drug substance and drug product. But what data is required? How should Module 3 be structured? These are the topics of our e-learning program.In this e-Learning you will: - learn that Module 3 is divided into drug substance and drug product parts - take a detailed look at the individual subchapters, their meaning and special requirements - get to know what data is essential for the respective subchapters and why - and learn the roles of the ASMF and CEP, and how to integrate them into Module 3.This e-learning was newly created and updated in August 2025.ZielgruppenThis e-Learning program addresses the needs of those working in the pharmaceutical industry. It will particularly benefit those needing a good knowledge of the structure and content of CTD Module 3.