Health technology assessments (HTAs) are the foundation of evidence-based decision-making for reimbursement, and coverage of medicines and medical technologies. Traditionally, the process has been heavily anchored in evidence from randomized controlled trials (RCTs), assessed at the time of market entry. However, healthcare systems have been evolving and are increasingly shifting toward a lifecycle approach to… Continue reading The Role of Real-World Data in HTA Reassessments
Tag: Health Authorities
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
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
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