Patient registry initiative- Strategy and mandate of the cross-committee task forceĮMA held a stakeholder workshop to better understand the barriers and facilitators to collaboration between stakeholders.
EMA has published the task force's strategy and mandate:
To support the initiative, EMA has set up a cross-committee task force on registries, comprising representatives from EMA scientific committees and working parties and experts from national competent authorities.
potential users of registry data, such as medicines regulators and pharmaceutical companies. registry coordinators, such as physicians' associations, patients' associations, academic institutions or national agencies responsible for overseeing healthcare services. To address the problems, the EMA initiative seeks to create a European Union-wide framework on patient registries, facilitating collaboration between: These factors have led to inefficiency and a duplication of efforts. harmonised protocols, scientific methods and data structures. coordination between ongoing initiatives at national and international levels. Regulators and pharmaceutical companies currently face a number of challenges in using existing registries or establishing new ones, including a lack of: The initiative for patient registries, launched in September 2015, explores ways of expanding the use of patient registries by introducing and supporting a systematic and standardised approach to their contribution to the benefit-risk evaluation of medicines within the European Economic Area. The European Medicines Agency (EMA) has set up an initiative to make better use of existing registries and facilitate the establishment of high-quality new registries if none provide an adequate source of post-authorisation data for regulatory decision-making. Patient registries can play an important role in monitoring the safety of medicines. Patient registries are organised systems that use observational methods to collect uniform data on a population defined by a particular disease, condition or exposure, and that is followed over time.
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