PTI - international

VII. Examine CTD Module 2 - Common Technical Document Summaries

• Analyze what needs to be included in module 2
  • CTD table of contents
  • CTD introduction
  • quality overall summary
  • nonclinical overview
  • clinical overview
  • nonclinical written and tabulated summaries
  • clinical summary
• Review FDA guidance related to module 2

VIII. Identify Best Practices for Speeding the Approval Process

• Review most common submission problems from an FDA reviewers perspective

Exercise: Perform Review of a Clinical Study Protocol and CMC submission from the FDA's Perspective and Discuss How to Improve

IX. Address the FDA's Concerns to Improve Chances of Approval

• Discuss FDA meeting outcomes and implementation
• Identify additional resources to predict FDA responses
• Assess risk to approval based on internal and external resources

Exercise: Develop a Risk Assessment with Mitigation and Contingency Plans for Addressing the FDA's Concerns

X. Explore eCTD Submission Opportunities: Software Packages and Electronic Submission

• Compare and contrast software and tools used in various regions
• Identify useful software packages for CTD submission
• Describe methods to effectively transition to the eCTD

XI. Evolve the CTD during FDA Review and After Approval

• Identify requirements for NDA/BLA amendments and supplements
• Locate resources for assistance while preparing a regulatory application

Exercise: Consider Possible Changes to the CTD and Discuss the Appropriate Filing Strategy