FORUM INSTITUT
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e-Learning: CTD Module 3
e-Learning:
CTD Module 3
2019-12-13 2019-12-13 Online Online

e-Learning: CTD Module 3

Data requirements in the EU

This e-Learning programme will familiarise you with the data requirements in CTD Module 3.
Topics
  • CTD structure and applicable guidelines
  • Drug substance Part
  • ASMF and CEP
  • Drug product part

This distinguishes our event

4
Modules
2
Hours of learning content
1
Control of success

Aims and objectives

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.

Who should attend
This e-Learning programme addresses the needs of those working in the pharmaceutical industry. It will particularly benefit those needing a good knowledge of the structure and content of CTD Module 3.
Your Expert
Lidia Cánovas
ASPHALION S.L., Barcelona, SPAIN


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