The utilization of database networks for post-marketing surveillance is essential in continuously monitoring the safety and effectiveness of medical products in the market. These networks enable the collection and analysis of real-world data, providing a comprehensive evaluation and identification of potential issues not captured in controlled clinical trials. Post-marketing surveillance involves passive vigilance, such as spontaneous reporting, and active clinical follow-up activities to systematically gather and analyze real-world data on adverse events and benefit-risk evaluation. Database networks enhance accuracy through mechanisms like real-world data collection, increased sample size, advanced data mining, collaboration, and effective signal detection and evaluation. Despite challenges in strengthening risk management models, improving the Sentinel Network, addressing underreporting, and ensuring resource allocation, post-marketing surveillance significantly benefits patients by ensuring ongoing safety, monitoring effectiveness, identifying unintended adverse events, improving existing treatments, increasing transparency in the regulatory process, and fostering communication among stakeholders.
This guide equips professionals with the knowledge and strategies to excel in safeguarding patient well-being throughout the lifecycle of medical products.