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

Die Themen

- CTD structure and applicable guidelines - Drug substance Part - ASMF and CEP - Drug product part

Ziele

Module 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.

Wer sollte teilnehmen?

This 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.