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More-EUROPA Webinars

Use of Registries in Regulatory Decision Making
Use of Registries in Regulatory Decision Making
More-Europa's first webinar was about use of registries in regulatory decision making.

On 21st November 2023, we gave a training session (webinar), where you had the opportunity to:

  • get the latest updates on registry-based activities in the context of healthcare research and data utilization;
  • understand the European Medicines Agency’s guidelines for registry-based studies, enhancing their ability to navigate regulatory processes effectively;
  • explore a specific case study on the use of registry-based real-world data in the regulatory process;
  • engage in a Q&A session with Health Technology Assessment (HTA) bodies and regulators. 
The information slides (.pdf) that were presented during the webinar now can be viewed.

You can also watch the webinar online (YouTube video):

Use of Registries in Regulatory Decision Making

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This is the first of a series of webinars and future topics will include:

 
  • How to appraise and apply machine learning and/or artificial intelligence approaches to identify relevant registries, additional data and determine relevant confounders and outcomes;
  • How real-world data elements can augment clinical trial performance, and how to use registries as a source for external comparator data;
  • Methods to access registry data, data sharing (consent and privacy), and federated analyses;
  • How to evaluate and design registry based RCTs.