Description
PSUR/PBRER Periodic Safety Reports – Pharmacovigilance Documentation
Periodic Safety Update Reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs) are critical pharmacovigilance documents that provide comprehensive evaluations of your product’s benefit-risk profile based on all available safety data. These reports are regulatory requirements that must be submitted at defined intervals throughout a product’s lifecycle.
Editverse provides complete PSUR/PBRER development services delivered by experienced pharmacovigilance and medical writers who understand global regulatory expectations and the critical importance of accurate, timely submissions.
Understanding PSUR vs PBRER
| Document | Regulatory Region | Primary Focus |
|---|---|---|
| PSUR | EU (EMA), many other regions | EU-specific safety assessment aligned with GVP Module VII |
| PBRER | ICH regions (global harmonization) | Global benefit-risk evaluation per ICH E2C(R2) |
Note: In the EU, PBRER format is used but submitted as “PSUR” per GVP Module VII requirements.
Regulatory Framework
| Guideline | Requirement |
|---|---|
| ICH E2C(R2) | Periodic Benefit-Risk Evaluation Report – global PBRER standard |
| GVP Module VII | Periodic Safety Update Report – EU-specific requirements |
| EU Regulation 726/2004 | Centralized procedure PSUR requirements |
| EURD List | European Union Reference Dates – defines DLP and submission timing |
| FDA 21 CFR 314.80 | US periodic reporting requirements |
PBRER/PSUR Structure (ICH E2C(R2))
| Section | Content |
|---|---|
| 1. Introduction | Product identification, reporting interval, data lock point |
| 2. Worldwide Marketing Status | Authorization status, launches, withdrawals by country |
| 3. Actions in Reporting Interval | Safety-related regulatory actions, labeling changes |
| 4. Reference Safety Information | Reference product information for expectedness determination |
| 5. Estimated Exposure | Patient exposure from clinical trials and post-marketing |
| 6. Data in Summary Tabulations | Summary tables of cumulative and interval adverse events |
| 7. Summaries of Significant Findings | Clinical trials, non-interventional studies, post-marketing data, literature |
| 8-14. Detailed Safety Assessments | Signals, safety concerns evaluation, targeted safety issues |
| 15. Integrated Benefit-Risk Analysis | Benefit-risk evaluation for approved indications |
| 16-17. Conclusions and Appendices | Overall conclusions, proposed actions, supporting data |
Service Options
| Service | Description | Timeline |
|---|---|---|
| Full PBRER/PSUR | Complete periodic report development | 6-10 weeks |
| PSUR Update | Update from previous PSUR with new interval data | 4-6 weeks |
| First PSUR (Post-Approval) | Initial PSUR following marketing authorization | 8-10 weeks |
| PRAC Response | Response to PRAC assessment report questions | 2-4 weeks |
| Regional Adaptation | Adaptation of global PBRER for regional submission | 2-3 weeks |
Development Workflow
| Phase | Activities | Timing |
|---|---|---|
| 1. Planning | DLP confirmation, data inventory, timeline alignment | DLP -10 weeks |
| 2. Data Collection | Safety database queries, literature search, exposure data | DLP -8 weeks |
| 3. Signal Evaluation | Review signals, assess safety concerns | DLP -6 weeks |
| 4. Drafting | Write all PBRER sections | DLP -4 weeks |
| 5. Benefit-Risk Analysis | Develop integrated benefit-risk evaluation | DLP -3 weeks |
| 6. Review & QC | Internal and sponsor review cycles | DLP -2 weeks |
| 7. Finalization | Final QC, portal upload preparation | DLP +60 days |
DLP = Data Lock Point. EU submission deadline is DLP + 70 days.
Key Components We Deliver
- Signal Detection Review – Analysis of new safety signals in the interval
- Aggregate Data Analysis – Cumulative and interval adverse event summaries
- Literature Review – Systematic search and safety assessment
- Benefit-Risk Evaluation – Comprehensive B-R analysis per ICH E2C(R2)
- RSI Comparison – Labeling gap analysis and proposed changes
- Line Listings – As required for specific safety concerns
Why Choose Editverse
| Feature | Benefit |
|---|---|
| PV Expertise | Writers with pharmacovigilance background and GVP knowledge |
| Timeline Management | Experienced with regulatory deadlines and EURD compliance |
| Signal Assessment | Expertise in signal evaluation and causality assessment |
| Benefit-Risk Frameworks | Structured B-R analysis methodology |
| Regulatory Interaction | PRAC response and follow-up support |
Deliverables
- Complete PBRER/PSUR – All sections per ICH E2C(R2) and GVP Module VII
- Summary Tabulations – AE tables by SOC, PT, seriousness, causality
- Supporting Appendices – Line listings, reference safety information
- Word and PDF Formats – Portal-ready documents
- Submission Package – Ready for PSUR Repository upload
Get Started
Contact us early to align with your DLP and submission timeline:
Email: co*****@*******se.com
Web: editverse.com
Pricing provided in your local currency. Multi-PSUR contracts available for ongoing products.
