Course Agenda
9:30AM – 10:30AM: Lecture 1:

FDA's Latest Guidance Documents
  • The difference between CTD and eCTD
  • FDA and ICH guidance documents
  • Overview of a CTD: Modules 1-5
  • Detailed explanation of the latest FDA guidance document 

Ground Rules for Writing, Formatting and Updating Content
  • Formatting and version control for content intended for electronic submission
  • Using MS Office and Adobe elements to create e-ready documents
  • Hyperlinks and cross-links in an XML environment
  • Best practices for MS Word and Adobe PDF in an eCTD environment
  • Off-the shelf software versus manual editing

10:30 – 10:45AM: Break

11AM – 12 Noon: Lecture 2: 

​Module 1 of an eCTD
  • Organization of Module 1
  • IT & Regulatory Responsibilities
  • Forms, certifications, and other components of Module 1
  • Application fees, waivers, and correspondence
  • NDA pre-submission number requests, secure email set-up
  • National and multi-national applications
  • Handling Amendments to M1

Module 2: Summaries in an NDA
  • Descriptions of each section of Module 2
  • Granularity requirements
  • Cross-linking Module 2 with Modules 3-5
  • Writing styles for summaries and review of information
  • Use of Tables, lists, figures and flow-charts
  • Handling Amendments to M2

12:00 – 12:45PM: Lunch Break

12:45PM – 2:00PM: Lecture 3: ​

​Module 3: CMC Information Presentation
  • Organizing the CMC information in an NDA
  • Granularity and limitations of each section
  • Minimum requirements for reports, testing data, and other documents
  • Managing large files
  • Content duplication and reference limitations
  • Handling Amendments to M3
2:00PM – 2:15PM: Break

2:15PM – 3:30PM: Lecture 4: ​

Modules 4 and 5: Bulk Data from Non-Clinical and Clinical Studies

  • CTD/ICH format for study reports
  • General organization of study reports in Modules, Study Tagging Files, Study Data Specifications
  • Linking Module 2 with Modules 3 and 4: Micro-summaries verses Macro summaries
  • Managing different PDF files: scanned verses de novo
  • Cross-linking and hyper linking: pivotal verses non-pivotal studies
  • Handling Amendments to M4 and M5

3.30PM – 3:45PM: Break
​
3:45PM – 4:30PM: Lecture 5: ​

Putting the Whole Submission Together
  • Cross-Referencing between Submissions
  • Compiling the full eCTD, Submission Lifecycles, Singular vs. Grouped Submissions
  • Validation of Submission Materials
  • Acknowledgment and tracking submissions

Introduction to the FDA’s ESG
  • What is the Electronic Submission Gateway (ESG)
  • Submitting to the electronic document room versus ESG
  • Stepwise instructions in creating an ESG account: Hardware and software, ESG Checklist
  • Set-up, validation, and testing of ESG account
  • Virus scanning requirements and uploading to ESG
  • Direct versus Web-trader accounts​