Pharmacovigilance white paper

Even though regulatory authorities such as the FDA and the EMA enforce these regulations primarily for public safety, non-compliance can have a serious impact on the manufacturers of pharma products. A failure in drug safety can not only cost a company millions, it can destroy their reputation and lead to criminal legal action being taken against them.

Because of this, it is imperative that PV departments understand precisely what their obligations are with regards to regulatory compliance. The goal of this white paper is to:

  • Concisely summarise the current landscape of EU and US regulations concerning PV
  • Identify areas of critical concern
  • Provide valuable guidance to those seeking to achieve excellence in their PV operations



Regulations are vital in maintaining the public’s trust in the pharmaceutical industry, and ensure that the products they are using are safe and effective.

EU regulations

The EU pharmacovigilance system is one of the most advanced and comprehensive in the world and provides a robust and transparent system to ensure a high level of public health protection throughout the EU.

Recent amendments to legislation have seen the EU take a far more risk-based approach to PV, setting minimum requirements for the quality systems of all stakeholders that allow uncertainties in safety and the performance of pharmacovigilance activities to be handled proactively and efficiently.

Good pharmacovigilance practices (GVP) support the legislation and cover major PV practices such as how to maintain effective quality management systems, how to develop balanced risk management plans, and how to conduct consistent PV audits.

US regulations

In the US, the principal drug safety regulations are found in 21 CFR Part 312 for Investigational New Drug Applications, and 21 CFR Part 314 for New Drug Applications and post-marketing reporting of ADRs.

All manufacturers of medicinal products are obliged by FDA regulations to submit every adverse event (AE) report they receive to the FDA. Similar to the GVP modules found in the EU, the FDA provide GVP guidance to facilitate regulatory and statutory requirements.



Risk minimisation measures (RMMs) are a key component of risk management plans (RMPs) and are the driving factor behind improving the risk/benefit profile of a medicinal product.

Creating a dynamic risk register in Q-Pulse’s Documents module is the best way to implement and track RMMs. The module allows you to input risks, consisting of potential AEs, plus the preventative barriers and mitigating controls. Each risk can exist as a document within the repository. It can be created collaboratively, edited, approved, published, distributed, reviewed and withdrawn. When new information becomes available that can strengthen a preventive barrier, it simply becomes a matter of updating the control description in the relevant procedure document.

This approach to risk documentation and management is of high priority to both the EMA and FDA, as it compels drug manufacturers, distributors and healthcare professionals to look at risk proactively, which in turn makes PV practices safer and more effective.

In responding to an event, problem or concern, Q-Pulse’s Reporting module includes risk assessment and analysis tools that enable:

  • Risk assessment throughout the AE reporting process
  • Automatic visibility of new events and reports
  • Attachment of new evidence to support the reporting process
  • Manage findings and outcomes
  • Analysis for continuous improvement and risk mitigation purposes

The visualisation of risk in the Reporting module shows a quantification of:

  • Initial level of risk (post-AE)
  • Interim level of risk (during mitigation)
  • Final level of risk (after mitigation is effective)

Next-steps guidance is also shown for consistent decision support across teams. Each risk can be assigned:

  • A name, description and revision number
  • A likelihood and severity dimension



Pharmacovigilance is a continuous responsibility in the life cycle of medical products and you need an effective software solution that allows you to manage the safety, quality and risk concerns that permeate this industry. Q-Pulse can provide invaluable support to those looking to adopt:

  • A proactive risk management system
  • More streamlined and efficient reporting practices
  • A ready approach to periodic PV inspections
  • Full compliance with EU and US GVP

Ideagen’s quality, safety and risk management software Q-Pulses offer a complete solution to achieving regulatory compliance and operational excellence.

Download the Pharmacovigilance white paper whitepaper.

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