Regulatory Open Forum

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Learn how to structure your first eCTD submission

  • 1.  Learn how to structure your first eCTD submission

    Posted 11 days ago


    We wanted to give this group an extra heads up about the upcoming Introduction to eCTD: Structuring Your First CTD-based Submission workshop happening 17-18 June. It’ll be informative and a great place to get your most pressing questions answered about CTD-based submissions.  

    Speakers Marianne Mowrer and Nora Keeling will explain: 

    • Different submission types 

    • Which applications need to be submitted electronically 

    • How to understand and follow the CTD structure 

    • How to use the M4 guidance series and granularity to generate compliant submissions 

    • Agency-compliant PDF files, and how to generate them 

    • Which agency guidelines and technical specifications publishers need to follow 

    • What tools are required to submit your applications electronically?  

    We hope to see you in June. Register here. 

    Brooke Keith
    Denver CO
    United States