PSUR and PADER Scorecard

 

 
SJ Pharma Consulting, LLC in Mendham, NJ provides Excel spreadsheets that are designed to generate a quality score from the review of a company's PSUR and US periodic reports. Quality measures are used to derive the scores.
 

Quality Scorecard – PSUR

 

Scientific Rigor and Data Accuracy

 
Title Page
Executive Summary
Table of Contents (Only After Draft Publication)
 
 
  • Section 1: Introduction
  • Section 2: Registration and Marketing Status
  • Section 3: Regulatory or Partner/Company Actions Taken for Safety Issues
  • Section 4: Changes to Safety Information
  • Section 5: Estimated Drug Exposure
  • Section 6: Presentation of Cases
 
 
 
  • Section 7: Studies
  • Section 8: Studies
  • Section 9: Overall Safety Evaluation
  • Section 10: Conclusion
  • Section 11: Appendices
 
 
 
 
 
 
 

English Writing

 
  • Grammar or Spelling and Style
  • Use of Vocabulary
  • Format
 
 
 

Medical Judgment

 
  • Medical Assessments (Sections 6 and 9)
  • Content Organization
  • Summary of Medicinal Information
  • Sentinel Events
 
 
 

Comments and Notes

 
 
 
 
 
 

Quality Scorecard – PADER

 

Scientific Rigor and Data Accuracy

 
Cover Page
Title Page (Draft Version)
Table of Contents (Only After Draft Publication)
  • Section 1: (1A1 to 1B2)
  • Section 2
  • Section 3
  • Section 4: Prescribing Information (Verify From Supporting Documentation)

 

English Writing

 
  • Grammar or Spelling and Style
  • Use of Vocabulary
  • Format