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
Category: Methodology
Transportability in Real-World Evidence (RWE) Research: Regulatory Considerations
What is Transportability in RWE?Transportability in Real-World Evidence (RWE) research refers to the ability to extend findings from one study population to a different, but related, population. This concept is critical when evaluating whether treatment effects observed in one geographical region, healthcare system, or patient cohort could be generalized to another population with different demographic,… Continue reading Transportability in Real-World Evidence (RWE) Research: Regulatory Considerations
HealthData@EU: Cross-Border Healthcare Data Sharing in Europe
With the evolving data-driven innovation, the ability to securely share health information across borders has become important for advancing medical research, improving patient care, and supporting public health initiatives. The European Union has taken a significant step forward with HealthData@EU, an innovative initiative aimed at creating a unified framework for cross-border healthcare data sharing. … Continue reading HealthData@EU: Cross-Border Healthcare Data Sharing in Europe
AI-Driven Protocol Digitalization: Reshaping Clinical Research
The integration of artificial intelligence (AI) into clinical trial protocol digitalization is transforming key aspects of drug development. By applying analytical and predictive AI, there is the potential to design smarter, more efficient protocols, ensuring greater precision in endpoint definition, improved compliance, and reduced trial timelines. This article explores some of the applications AI… Continue reading AI-Driven Protocol Digitalization: Reshaping Clinical Research
Digital Twins in Healthcare: Unlocking Potential and Overcoming Challenges
The concept of digital twins has gained significant attention in recent years, revolutionizing industries such as manufacturing, urban planning, and increasingly, and healthcare. A digital twin is a virtual replica of a physical object, system, or process, enabling real-time monitoring, simulation, and analysis. By creating a digital version of something in the real world, industries… Continue reading Digital Twins in Healthcare: Unlocking Potential and Overcoming Challenges