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.
Kursinhalt
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Kursmodul Module 1: Introduction
Content:CTD Module 3 structureGuidelines applicableAfter having passed this section you know the structure of the CTD Module 3 as well as essential quality guidelines.
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Kursmodul Module 2: Drug Substance Part
Content:CTD Module 3 drug substance data requirementsAfter having passed this module you know the subchapters of the Drug Substance part 3.2.S and the data requirements in detail.
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Kursmodul 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.
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Kursmodul Module 4: Drug Product Part
Content:CTD Module 3 - drug product data requirementsAppendices and Regional InformationAfter having passed this module you know the chapters and subchapters of the Drug Substance part 3.2.P ...
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Kursmodul Test
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Kursmodul Feedback