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