In recent years, Real-World Data (RWD) has revolutionized human healthcare, driving better decision-making, drug development, and patient outcomes. Yet, another promising and rapidly evolving area for RWD innovation lies in veterinary medicine. As pets are increasingly becoming cherished family members and demand for advanced veterinary care, RWD offers an unprecedented opportunity to also transform animal… Continue reading The Potential of RWD in Veterinary Medicine: A New Frontier for Pet Health
Tag: Regulatory
Methodological Considerations in RWD Studies by Intended Use
The growing acceptance of real-world data (RWD) and real-world evidence (RWE) has expanded the horizon for how we generate insights to support decision-making across the product lifecycle. However, while the value of RWD is increasingly recognized by regulators, payers, and safety bodies, the design and methodological rigor of these studies must be carefully tailored to… Continue reading Methodological Considerations in RWD Studies by Intended Use
Fragmented Foundations: Why GEP Needs Global Standards Now
1. BackgroundEpidemiology studies the causes and consequences of morbidity and mortality across geographical boundaries, with emphasis on equitable disease control and health promotion in low-income and middle-income countries [1]. During the past decade, research integrity and research fairness have gained considerable momentum as they have direct implications for global health epidemiology [1]. Research integrity has emerged… Continue reading Fragmented Foundations: Why GEP Needs Global Standards Now
Conducting Post-Authorization Safety Studies (PASS) in Italy: Regulatory and Best Practice Considerations
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
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