Virtual Classroom Training

Bespoke interactive e-learning

This course will cover everything you need to know to submit compliant eCTD submissions to the FDA!

Type: Virtual Classroom Training

Duration: 1 Day (divided into two 0.5-day sessions)

Who should attend?: People who have basic knowledge of eCTD but would like to better understand the US requirements

This course will cover everything you need to know to submit compliant eCTD submissions to the FDA!

  • Overview of eCTD related FDA Regulations and Guidance Documents
  • Compliant Documents
    • Document formatting
      • Source Document QC
      • Review of common scenarios and issues
        • Update Table of Contents, List of Tables, List of Figures
        • Search for table not found, etc.
        • Headers, footers, etc.
      • PDF Preparation (pre-publishing)
        • PDF conversion, PDF settings, Bookmarking, Internal Hyperlinks, Compliance with FDA PDF Specification
        • Review of common scenarios and issues
        • Literature references, CVs/1572s, Module 1 forms & cover letter
      • eCTD Publishing/Compilation
        • Module 1 Attributes for Regional XML
        • Metadata examples for various submission types and sub-types
        • Updating your application – typical scenarios for replacing documents in the lifecycle
        • Clinical Study Reports
        • IND Safety Reports
        • Datasets
        • Study Tagging Files
        • SPLs (Structured Product Labeling)
        • Validation
      • Electronic Submission Gateway Setup and submission
      • Submission Management Process
        • Submission Management
        • Tracker
        • Document transfer

Adair Turner

Adair Turner joined PharmaLex in 2017 as Director, Regulatory Operations and is responsible for electronic submission activities for the US and Canada. Adair has more than 17 years of experience in Regulatory Affairs and Operations.

Melissa Rapp joined PharmaLex in 2018 as Manager, Regulatory Operations is responsible for providing US submission management services for global clients.

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