e-Learning: CTD Module 3
Data requirements in the EU
- CTD structure and applicable guidelines
- Drug substance Part
- ASMF and CEP
- Drug product part
This distinguishes our event
Aims and objectivesModule 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.
- CTD Module 3 structure
- Applicable guidelines
- CTD Module 3 drug substance data requirements
- Application and use
- CTD Module 3 drug product data requirements
- Appendices and regional information
The 'CTD Module 3' e-learning programme comprises four didactic modules that include videos in which expert Lidia Cánovas shares her expertise with you. You can also download and print the corresponding presentation documents. Each module also includes additional documents (links, guideline texts, etc.). The e-learning ends with an online test, which helps you practise and apply your newly gained knowledge. Once you have completed the four modules and passed the test, you will be awarded a certificate, which you can print out directly. The e-learning programme should be completed within three months.
1. Register for an e-learning programme on our website. 2. You will receive an email with your login data for access to our learning platform. 3. Log in to start your e-learning programme. 4. Complete the modules at your own pace. 5. Complete a multiple-choice test. 6. Once you have passed the test, you will be awarded a certificate, which you can then print out. Try out the demo versions of our e-learning programmes to get an idea of our learning environment.