CTD Module 3

You will find all the important information you need to complete the e-Learning programme here.

Content:

• CTD Module 3 structure
• Guidelines applicable

After having passed this section you know the structure of the CTD Module 3 as well as essential quality guidelines.

Content:

• CTD Module 3 drug substance data requirements

After having passed this module you know the subchapters of the Drug Substance part 3.2.S and the data requirements in detail.

Content:

• Application and use
• Structure
• Procedure

After having passed this module you know which function an ASMF or CEP fulfils, when this can be used and who submits it.

Content:

• CTD Module 3 - drug product data requirements
• Appendices and Regional Information
  

After having passed this module you know the chapters and subchapters of the Drug Substance part 3.2.P and the data requirements. You will also know what information should be given in the appendices and the regional information.