Kurs derzeit nicht verfügbar
e-Learning: CTD Module 3 - Data requirements in the EU
Seminar
Online
Beschreibung
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Kursart
Seminar
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Methodik
Online
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Dauer
1 Tag
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.
Hinweise zu diesem Kurs
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.
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Themen
- E-learning
Inhalte
e-Learning: CTD Module 3 - Data requirements in the EU