Teamit Institute is proud to announce their presence in the new HMA-EMA catalogues. The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have launched an innovative tool for stakeholders in European healthcare and pharmacovigilance: the HMA-EMA Catalogues of real-world data sources and studies. These catalogues, launched in February 2024, are comprehensive databases designed to support regulatory bodies, research institutions, industry and healthcare professionals by providing transparent access to crucial Real-World Data (RWD) sources within Europe and beyond.
Importance of Real-World Data
Real-World Data, which encompasses information collected from routine healthcare settings such as electronic health records and disease registries, has become imperative in evaluating the safety and effectiveness of medicines. The COVID-19 pandemic underscored its value, demonstrating how real-world insights can inform timely public health interventions. The HMA-EMA Catalogues address the complexities of data sharing across European institutions and aim to foster cross-border collaboration, enhance data quality, and promote efficient data utilisation within the regulatory landscape.
Contents of the HMA-EMA RWD Catalogues
The HMA-EMA RWD Catalogues contain detailed information on:
- Data Sources: this includes comprehensive listings of RWD sources, from electronic health records to disease registries.
- Studies: the catalogue provides access to a wide range of studies, including protocols, country-specific information, and context, scope and relevance.
- Institutions: European institutions with a stake in medicine regulation and public health are listed. Each institution entry offers insights into its resources, expertise, and areas of research.
- Networks: Key networks dedicated to advancing RWD use in Europe are also included, facilitating collaborative interdisciplinary efforts.
Significance of the HMA-EMA Catalogue & Teamit Institute’s Role
Among the listed institutions is Teamit Institute, specialising in scientific management of pharmacoepidemiology research and regulatory science initiatives. Teamit Institute’s inclusion in the catalogues underscores its role in advancing real-world evidence (RWE) and RWD initiatives, supporting evidence-based healthcare decisions and regulatory actions across Europe. Teamit has an established track record in the scientific management of pharmacoepidemiology and pharmacovigilance studies, contributing to numerous studies and participating in three key research networks: VAC4EU, the EU PE&PV Network, and the EU-ADR Alliance, all of which are part of the HMA-EMA catalogues. These networks specialise in critical areas such as vaccine and drug safety, effectiveness, pharmacoepidemiology, and real-world evidence (RWE) research.
The HMA-EMA Catalogue represents a significant advancement in European medicines regulation. By providing access to high-quality RWD sources, studies, and collaborations, the catalogue supports data-driven, transparent, and effective regulatory decision-making. Through its active involvement in these networks, Teamit Institute plays a key role in advancing data-driven research and enhancing the understanding of the real-world impact of medical interventions. Teamit institute’s contribution to evidence generation and scientific collaboration, helps shape the future of healthcare and public health policy across Europe, driving innovation and ensuring informed decision-making for better health outcomes.
