PSUR & PBRER Automation/Generation Software for PV – DrugCard

PSUR & PBRER Automation/Generation Software for PV

Automate the preparation of Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs)
using AI, integrated safety data, and structured regulatory workflows.

Reduce Weeks of Manual Work to a Structured Automated Process

Preparing a PSUR / PBRER often requires collecting information from multiple
disconnected systems, reviewing thousands of publications, comparing product
information versions, and manually compiling regulatory sections. DrugCard automates these repetitive activities while keeping your pharmacovigilance
experts fully responsible for scientific review and regulatory decisions.

Intelligent Data Collection

Instead of manually gathering information from different repositories, DrugCard automatically consolidates safety
information from connected modules and previous
submissions into one structured workflow.

AI-Assisted Report Generation

The platform automatically generates a structured PSUR / PBRER draft based on available safety information and
predefined report requirements.

Automatic Safety Data Analysis

DrugCard analyzes categorized literature, adverse event
information, regulatory updates, and historical safety data to identify relevant findings during the reporting period.

Benefit-Risk Assessment Support

Automatically generate draft sections covering: Signal
evaluation; Risk assessment; Benefit evaluation; Integrated benefit-risk analysis. While leaving the final scientific
judgement to pharmacovigilance specialists.

Automatic Product Information Comparison

Compare previous and current product information to
automatically detect: Label updates; Safety changes; New warnings; Modified sections. Without performing manual
line-by-line reviews.

Ready-to-Edit Microsoft Word Output

Generate an editable Microsoft Word document that can
immediately enter your internal review and approval workflow.

Does this sound like a solution that could help your team right now?

Key Features

Structured PSUR/PBRER draft generation

Automatic population of product-specific information

Integration with Literature Monitoring

Integration with the DrugCard ADR Database

AI-assisted analysis of categorized safety information

Signal and benefit-risk evaluation support

Automatic comparison of product information versions

Editable Microsoft Word output

How It Works

1. DrugCard Collects Available Data

The platform automatically retrieves applicant information, medicinal product details, reporting periods, previous submissions, and other available documentation from the DrugCard platform.

2. Analyze Safety Information

DrugCard combines data from Literature Monitoring, the ADR Database, Regulatory Intelligence, and categorized safety information to identify relevant findings during the reporting period.

3. Generate the PSUR/PBRER Draft

The platform automatically prepares a structured PSUR/PBRER with populated sections, integrated safety analyses, benefit-risk evaluation, and detected product information changes.

4. Expert Review & Finalization

Pharmacovigilance specialists review, refine, and approve the report before submission, ensuring full regulatory compliance.

Why Pharmacovigilance Teams Choose DrugCard for PSUR / PBRER Preparation

Less Administrative Work

Reduce repetitive document preparation and manual copy-paste between systems.

Better Data Consistency

Reuse validated information already available across the DrugCard platform.

Faster Reporting Cycles

Generate comprehensive draft reports in hours instead of spending weeks assembling information manually.

Integrated Pharmacovigilance Platform

Unlike standalone document generators, DrugCard connects literature monitoring, safety databases, regulatory intelligence, and reporting within one ecosystem.

Human Experts Stay in Control

DrugCard automates PSUR/PBRER preparation. Your pharmacovigilance specialists make the scientific decisions.

Need expert-led PSUR preparation instead? Explore our PSUR Services.

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