Updated timeline for the use of eAFs for variations in human drugs
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Where is DADI? - The new EMA eAF: Definition and Impact
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When can companies expect to use eCTD 4.0?
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What is eCTD 4.0?
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What are the regional differences of eCTD?
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What are the 5 Modules of eCTD? - Introduction to the CTD Triangle
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What is eCTD? - The story of the electronic Common Technical Document
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Regulatory Authorities worldwide - an overview list
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The EMA published the FHIR Conceptual Data Model (CDM)
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US FDA Adverse Event Reporting System (FAERS) Electronic Submissions
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EMA Publishes New Timeline For DADI Project
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US FDA Adopts ICH Clinical Trials Guideline with Exclusive Reference to E2B(R3) Standards
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