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.