PSUR WRITING MANUAL
At SJ Pharma Consulting, LLC in Mendham, NJ, we provide our clients with a 100-page manual that has detailed instructions concerning how to prepare an E2C-compliant PSUR. The manual includes the steps that are required to extract supporting data from the safety database.
Table of Contents
| 1.0 List of Tables | 6 | ||
| 2.0 List of Figures | 7 | ||
| 3.0 References | 8 | ||
| 4.0 Definitions, Acronyms, and Abbreviations | 8 | ||
| 5.0 PSUR Overview | 13 | ||
| 5.1 | Introduction | 13 | |
| 5.2 | Scope of Information | 13 | |
| 5.3 | Purpose of PSURS | 14 | |
| 5.4 | Product Authorization | 14 | |
| 6.0 Frequency of Review and Reporting | 15 | ||
| 6.1 | Regular and Ad Hoc Submission of Periodic Safety Update Reports | 15 | |
| 6.2 | PSURS – Other Countries | 16 | |
| 7.0 PSUR Preparation | 17 | ||
| 7.1 | PSUR Process Workflow | 17 | |
| 7.2 | Matrix of Job Roles and Responsibilities | 18 | |
| 7.3 | Table of Symbols Used in ARISg | 19 | |
| 8.0 Periodic Safety Update Report (PSUR) – Format | 20 | ||
| 8.1 | Executive Summary | 20 | |
| 8.2 | Introduction | 20 | |
| 8.2.1 World Wide Market Authorization Status | 20 | ||
| 8.3 | Update of Regulatory Authority or MAH Actions Taken for Safety Reasons | 21 | |
| 8.4 | Changes to Reference Safety Information | 21 | |
| 8.5 | Patient Exposure | 22 | |
| 8.6 | Presentation of Individual Case Histories | 22 | |
| 8.7 | Cases Presented in the Line Listings | 22 | |
| 8.8 | Presentation of the Line Listings | 23 | |
| 8.9 | Summary Tabulations | 24 | |
| 8.10 | Cumulative Listing of Serious Adverse Drug Reactions | 24 | |
| 8.11 | Market Authorization Holder(s) | 25 | |
| 8.12 | Studies | 25 | |
| 8.13 | Newly Analyzed Company Sponsored Studies | 25 | |
| 8.14 | Targeted New Safety Studies | 25 | |
| 8.15 | Other Information | 25 | |
| 8.15.1 Efficacy Related Information | 25 | ||
| 8.15.2 Late-Breaking Information | 25 | ||
| 8.15.3 Risk Management Plan | 25 | ||
| 8.15.4 Risk-Benefit Analysis Report | 26 | ||
| 8.16 | Overall Safety Evaluation | 26 | |
| 8.17 | Conclusion | 26 | |
| 9.0 Running the PSUR | 26 | ||
| 9.1 | Safety Systems Aggregate PSUR Line Listings and Summary Tables | 27 | |
| 9.2 | Generating the PSUR Line Listing Tabulations | 27 | |
| 9.2.1 ARISg Admin Module Selection | 28 | ||
| 10.0 General Information | 38 | ||
| 11.0 Medically Confirmed, Spontaneous, and Authority, Non-Serious/Listed Adverse Events | 38 | ||
| 12.0 Medically Unconfirmed, Spontaneous, and Authority Adverse Events | 41 | ||
| 13.0 Cumulative Listing | 44 | ||
| 14.0 Batch Updating Procedures | 47 | ||
| 14.1 | Saving and Naming Procedures for PSUR Batch Updating Files | 49 | |
| 14.2 | Saving and Naming Procedures for Selected AER Files | 50 | |
| 15.0 Run-Time Parameters | 51 | ||
| 16.0 Attachments (Appendices) | 68 | ||
| 16.1 | Appendix 1: Scheduling Procedure Document | 69 | |
| 17.0 Appendix 2: Pharmacovigilance Aggregate Reports Definitions | 79 | ||
| 17.1 | Appendix 3: PSUR QC Check List | 82 | |
| 17.2 | Appendix 4: PSUR Template | 86 | |
| 18.0 Description of the Drug | 89 | ||
| 19.0 Global Registration and Marketing Status | 90 | ||
| 20.0 Changes to Reference Safety Information | 91 | ||
| 21.0 Estimated Drug Exposure | 92 | ||
| 22.0 Presentation of Individual Cases | 94 | ||
| 23.0 Individual Case History Analysis | 95 | ||
| 24.0 Initial Reports | 98 | ||
| 25.0 Follow-Up Reports Containing New Medically Significant Information | 98 | ||
| 26.0 Medical Assessment | 98 | ||
The PSUR WRITING MANUAL is available for $1000