PTI - international

• Define common statistical terms and concepts
• Examine statistical techniques relevant to APRs
• Interpret statistical data to identify trends and deviations

Exercise: Identify Scenarios in which Statistical Analysis Could Be Used and Determine Optimal Methods

VIII. Use APRs to Improve Processes and Product Quality

• Form recommendations based upon data review
• Implement corrective actions, if necessary
• Conduct semi-annual or more frequent reviews for ongoing quality surveillance

IX. Generate Documentation for APRs

• Organize and format an APR
• Evaluate different methods for APR documentation
• Obtain approval and sign-off from appropriate manager(s)

Exercise: Critique Required and Optional Content of an APR

X. Analyze FDA Enforcement Trends

• Identify what FDA inspectors expect to find in an APR
• Anticipate potential pitfalls
• Examine the consequences of non-compliance

Exercise: Review Warning Letters Citing APR Violations
Exercise: Conduct an Annual Product Review

XI. Implement Best Practices for Writing Annual Reports

• Examine link between Annual Product Reviews (APR) and Annual Reports (AR)
• Determine purpose of ARs
• Interpret regulatory requirements for ARs (21 CFR 314)
• Identify key sections of ARs:
  • brief summary of significant new information 
  • distribution data
  • labeling - revisions
  • chemistry, manufacturing and controls changes
  • nonclinical laboratory studies
  • clinical data
  • status reports – post-marketing clinical studies
• Apply good technical writing practices
• Anticipate and avoid common citations related to ARs

Exercise: Critique Sample ARs for NDAs