Pharma & Healthcare / Regulatory Affairs
CTD Module 3

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.


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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.
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Kursinhalt
  • Important information
    You will find all the important information you need to complete the e-Learning programme here.
    • First steps
    • Information on test
  • Module 1: Introduction
    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.
  • Module 2: Drug Substance Part
    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 de...
  • Module 3: ASMP & CEP
    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.
  • Module 4: Drug Product Part
    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 ...
  • Test
  • Feedback