PBRER and PSUR That Never Slip

Aggregate reports anchor your benefit–risk story. When they arrive late or feel

cobbled together, regulators question your control—and patients wait longer for

updates.

This playbook delivers punctual, high-quality PBRERs and PSURs. You will set

calendar anchors, enforce data locks, reuse proven templates, and manage cross-

functional contributions so every cycle runs like clockwork.

Why disciplined aggregate reporting matters

• Regulatory compliance: On-time PBRER/PSUR submission avoids escalation,

fines, and inspection findings.

• Signal management: Consistent reporting feeds safety strategy and label

updates.

• Affiliate confidence: Regional teams rely on timely insights for local

authorities.

• Resource planning: Predictable cycles reduce burnout and last-minute data

pulls.

Step 1: Publish a master reporting calendar

• Document submission dates, data lock points, drafting windows, governance

reviews, and QC milestones for the entire year.

• Align clinical, safety, medical writing, statistics, and affiliates on

responsibilities and deadlines.

• Use workflow tools to send automated reminders, escalating to leadership when

activities slip.

• Update the calendar after regulatory changes and communicate deltas immediately.

Step 2: Enforce disciplined data locks

• Freeze safety databases, literature sweeps, exposure metrics, and risk

management updates on a coordinated schedule.

• Define who can approve exceptions and how late entries are documented.

• Capture cut-off data snapshots and archive them with the report package for

audit readiness.

• Communicate lock expectations to outsourced vendors and affiliates; misaligned

timelines create rework.

Step 3: Maintain a living storyline

• Keep a running log of key safety events, signals, regulatory interactions, and

label changes throughout the reporting period.

• Draft high-level narratives early, using the log as a source. Update as new

information arrives instead of starting from scratch each cycle.

• Align medical writers and safety physicians on tone, structure, and key

messages before drafting begins.

Step 4: Reuse modular templates and analytics

• Create structured templates with reusable sections: executive summary, benefit–

risk evaluation, ongoing/planned studies, cumulative exposure tables.

• Store templates under version control and capture reviewer feedback for

continuous improvement.

• Automate table and figure generation by linking to validated data sources.

• Maintain a library of standard responses to frequent authority questions.

Step 5: Coordinate cross-functional contributions

• Assign owners for each section and provide clear instructions, word limits, and

evidence requirements.

• Schedule alignment meetings with medical, regulatory, statistics, and quality to

resolve issues early.

• Use collaboration platforms to manage comments, versioning, and approvals in a

single environment.

• Implement a final QC checklist covering data accuracy, references, citations,

and formatting.

Metrics that prove your process works

• On-time submission rate versus regulatory deadlines.

• Number of post-lock adjustments or late data inclusions.

• Reviewer rework hours per cycle.

• Duration from data lock to final sign-off.

• Audit or affiliate findings related to aggregate reports.

45-day roadmap

1. Days 1-10: Map current reporting tasks, identify bottlenecks, and capture

lessons from recent cycles.

2. Days 11-20: Publish the refreshed reporting calendar, define data lock

SOPs, and align stakeholders.

3. Days 21-30: Update templates, automate data pulls where possible, and

create the running storyline log.

4. Days 31-45: Pilot the enhanced process on the next report, track metrics,

and refine checklists before full rollout.

Frequently asked questions

• How firm should data locks be? Treat them as non-negotiable. Document and

justify any late additions with impact assessments.

• Can we reuse content across regions? Yes—maintain a core global dossier and

supplement with regional appendices as needed.

• How do we handle unexpected safety events near lock? Follow exception

procedures, update narratives promptly, and communicate with authorities if

inclusion delays the report.

• What tools help? Safety data warehouses, literature monitoring platforms,

collaboration suites, and automated publishing tools all reduce manual effort.

Sustain the win

Review reporting metrics after each cycle, update templates with inspector or

affiliate feedback, and rotate report leads so expertise spreads. Celebrate

flawless submissions to reinforce the discipline. When reports never slip,

regulators view your safety organization as fully in control.