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Requirements of an EU PV system – Signal Management

by Alex Xuereb, QA/PV specialist @Quintian Pharma

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Challenges Faced by Marketing Authorization Holders in Signal Management for Pharmacovigilance Systems

A critical part of any pharmacovigilance (PV) system is the process of signal management. As per article 19 of the Commission Implementing Regulation (EU) No 520/2012, Marketing Authorization Holders (MAHs) are legally required to identify new or changing adverse events related to their medicinal product or Active Pharmaceutical Ingredient (API). 

The challenge comes when deciding on how to identify, validate and act on these new adverse events in an appropriately scientific manner.  
Requirements of an EU PV system_Site PQE (1)

Current MAHs Issues

Many MAHs are faced with the following issues: 

  • Huge quantities of safety data, often in the form of spontaneous Adverse Drug Reports (ADRs) or as Individual Case Safety Reports (ICSRs), are collected or available that can vary greatly in quality.
  • The data being collected is decentralized and does not have the luxury of being collected from a clinical trial where variables can be tightly monitored and compared to a control.
  • EU guidelines on signal management leave room for interpretation and innovation, as they often do. This can be difficult for untrained personnel who are looking to transpose these guidelines into their own functioning PV and signal management systems.

Read the full article on QuintianPharma.com

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