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
The PSUR AND PADER SCORECARD is available for $250