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: Health Authorities
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
EMA's Strategic Initiatives for Addressing Unmet Medical Needs
An unmet need in healthcare refers to a gap where current medical knowledge, treatments, or healthcare services do not adequately address a particular condition, disease, or health issue. These unmet needs can arise in various aspects of healthcare, such as the availability of effective treatments, access to healthcare services, or the ability to diagnose and… Continue reading EMA's Strategic Initiatives for Addressing Unmet Medical Needs
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
Process for Health Technology Assessments (HTAs) in France
Health Technology Assessments (HTAs) in France are a key component of the healthcare system, used to evaluate the clinical efficacy, safety, and cost-effectiveness of new medical technologies, including drugs, devices, and procedures. The HTA process in France is highly structured and involves several key organizations, each with distinct roles and responsibilities. 1. High… Continue reading Process for Health Technology Assessments (HTAs) in France