Pharmacovigilance Gap Analysis: Strengthening Your Compliance Framework

What is Gap Analysis in Pharmacovigilance?

Gap analysis is a systematic approach to identifying shortcomings or inefficiencies in an organization’s pharmacovigilance system. It helps uncover areas that may not fully meet regulatory requirements, which can lead to compliance issues, delays in reporting, or gaps in safety monitoring.

Conducting a pharmacovigilance gap analysis allows companies to:

• Identify non-compliance with global regulations such as those set by the FDA, EMA, and ICH.
• Optimize internal processes for reporting, monitoring, and evaluating adverse events.
• Prevent costly delays or penalties by addressing gaps before they lead to regulatory scrutiny.

How Viltis Conducts a Comprehensive Gap Analysis

At Viltis, we specialize in performing thorough gap analyses to ensure your pharmacovigilance system operates at peak efficiency and is fully compliant with international regulations.

1. System Review: We begin with a deep dive into your current pharmacovigilance system, evaluating case processing, safety reporting, and risk management processes to identify any gaps or inefficiencies.

2. Regulatory Compliance Check: We compare your system against the latest guidelines from the FDA, EMA, PMDA, and other global health authorities to ensure you meet the necessary compliance standards.

3. Process Optimization: Once gaps are identified, we provide a detailed roadmap for closing those gaps—whether it's improving case intake processes, enhancing ICSR management, or streamlining safety reporting timelines.

4. Training and Implementation: We also provide training and implementation support to ensure that your team understands the changes required to maintain compliance and improve the efficiency of your pharmacovigilance operations.

The Benefits of a Gap Analysis for Pharmacovigilance

• Improved Compliance: Ensure your pharmacovigilance system aligns with international regulatory requirements, reducing the risk of fines or penalties.
• Enhanced Safety Monitoring: Close gaps in safety monitoring processes, leading to faster detection of safety signals and improved patient safety.
• Operational Efficiency: Identify and streamline inefficient processes to improve overall pharmacovigilance operations, reducing costs and improving reporting timelines.

By conducting a pharmacovigilance gap analysis, Viltis helps you build a compliance framework that not only meets global regulatory standards but also strengthens your overall approach to drug safety.