e-Learning: CTD Module 3 - Data requirements in the EU - E-Learning von FORUM Institut für Management GmbH

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 programme.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 updated in August 2022.