Common Technical Document and eCTD
This e-Learning programme will provide you with detailed knowledge on the structure and content of the (electronic) common technical document - the only valid dossier format for marketing authorisation applications for human pharmaceuticals in the...
Kursinhalt
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Kursmodul Module 1: CTD basic structure
Content:ICH and the origin of the CTDGeneral aspects of the CTDEU legislation - Eudralex - Notice to applicantsCTD Modules 1-5electronic CTD = eCTDLearning objectives: After having passed this mod...
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Kursmodul Module 2: Organisation and content of the CTD Modules
Content: Information "flow" in the CTD triangleModule 1 - Regional and Administrative documents (EU focus)Module 2 - Overviews and SummariesModule 3 - Quality (headings only)Module 4 and 5 - Study ...
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Kursmodul Module 3: Dossier considerations for Generics and other "un-complete" application types
Content:Application TypesData ExclusivityArticle 8(3) Full ApplicationArticle 10: Generic, Hybrid or Similar Biological Applications10a Well Established Use Applications10b (New) Fixed Dose Combina...
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Kursmodul Module 4: Details on CTD Module 3 & considerations for ASMF and CEP filings
Content:Module 4a: IntroductionCTD Module 3 structureGuidelines applicableModule 4b: Drug SubstanceCTD Module 3 drug substance data requirementsModule 4c: ASMP & CEPModule 4d: Drug ProductCTD M...
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