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: Regulatory
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
Navigating the Diverse Landscape of GDPR Interpretation in European Healthcare and Clinical Research
The General Data Protection Regulation (GDPR), since its implementation in May 2018, has significantly reshaped data protection laws across Europe. The GDPR was implemented to address the growing concerns about privacy and data protection in the digital age. As technology advanced and data became an integral part of daily life, the European Union (EU)… Continue reading Navigating the Diverse Landscape of GDPR Interpretation in European Healthcare and Clinical Research
Fit-for-Purpose in RWE: Comparing Regulatory Approaches Across Global Agencies
The concept of “fitness-for-purpose” (or fit-for-purpose) is a key definition in regulatory science, as it determines whether the data, methods, or tools used in a study are suitable for their intended purpose. In particular, “fit-for-purpose” in Real-World Evidence (RWE) research refers to the suitability of the data and study design for addressing a study design… Continue reading Fit-for-Purpose in RWE: Comparing Regulatory Approaches Across Global Agencies