Post-Authorization Safety Studies (PASS) are vital tools for monitoring the safety of medicines after they have been approved for use in the general population. In the European Union (EU), these studies are conducted within the framework established by the European Medicines Agency (EMA). However, when conducting a PASS under the EMA framework, there might be… Continue reading Conducting Post-Authorization Safety Studies (PASS) in Italy: Regulatory and Best Practice Considerations
Tag: Drug Safety
Harnessing the Power of AI: Revolutionizing Signal Detection in Drug Safety
Traditional methods of signal detection rely on manual review and analysis of large amounts of data, often resulting in delays and missed opportunities for early detection of signals. On the other hand, artificial intelligence (AI) has the potential to enhance activities in pharmacovigilance leading to a much earlier detection of potential safety concerns. But how… Continue reading Harnessing the Power of AI: Revolutionizing Signal Detection in Drug Safety
Leveraging Real-World Data: Enhancing Drug Safety in Clinical Practice
In healthcare, ensuring patient safety is one of the most important aspect. As new drugs are developed and introduced into the market, it becomes imperative to monitor their safety and efficacy beyond the controlled environment of clinical trials. This is where real-world data (RWD) steps in as a powerful tool, offering invaluable insights into the… Continue reading Leveraging Real-World Data: Enhancing Drug Safety in Clinical Practice