PTI - international

• Outline the phases of drug development
• Examine the steps of the NDA approval process
• Describe what happens after the application is approved
• Identify FDA and ICH guidance documents for NDAs and where to find them

Discussion: Identify Key Issues for NDA Review from the FDA's Perspective

II. Introduce the Common Technical Document (CTD)

• Provide background on the CTD
• Assess the advantages of using CTD format for your regulatory application
• Outline the basic CTD format (Modules 1-5)
• Explain the FDA's current interpretation of the CTD modules and approach to the submission process
• Discuss FDA and ICH plans for CTD implementation

Discussion: Can Using the CTD Format Address any of the NDA Review Issues from the FDA's Perspective?

III. Explore CTD Module 1- Administrative Information and Prescribing Information

• Outline the contents of module 1
  • table of contents of the submission including module 1
  • documents specific to each region
• Identify how CTD Requirements differ in various regions
  • Japan
  • Southeast Asia
  • EU
  • South Pacific
  • Eastern Europe
• Review FDA guidance related to module 1

Exercise: Prepare Module 1 from a Traditionally Formatted NDA

IV. Outline CTD Module 3 - Quality

• Describe the contents of module 3
  • module 3 table of contents
  • body of data
  • literature references
• Review FDA guidances related to module 3

Exercise: Prepare Module 3 from a Traditionally Formatted NDA

V. Describe CTD Module 4 - Non-Clinical Study Reports

• Identify what needs to be included in module 4
  • module 4 table of contents
  • study reports
  • literature references
• Review FDA guidance related to module 4

Exercise: Prepare Module 4 from a Traditionally Formatted NDA

VI. Examine CTD Module 5 - Clinical Study Reports

• Identify and describe the contents of module 5
  • module 5 table of contents
  • tabular listing of all clinical studies
  • clinical study reports
  • literature references
• Review FDA guidance related to module 5

Exercise: Prepare Module 5 from a Traditionally Formatted NDA