🎤 Regulatory-grade RWE from Nordic data – in focus

📅 On 26 November, Kelsi Smith, Senior Project Lead at Quantify Research, was invited to speak at an online webinar hosted by the Singapore Clinical Research Institute (SCRI) – Generating Real-World Evidence from Real-World Data in the Nordic Countries.

Her session explored how real-world data from the Nordics can be used to generate regulatory-grade evidence—meeting the requirements of agencies like the EMA.

Topics included:
▶️ Key considerations of data in order to be considered regulatory grade
▶️ Developments in regulatory bodies (EMA, FDA, NICE) accepting Nordic RWE studies
▶️ An overview of Nordic register-based data and types of data available
▶️ Designing and executing PASS using Swedish register data
▶️ Other types of studies such as external control arms

🔎 It was a valuable opportunity to share how rigorous, transparent, and well-governed register-based research supports life science innovation and informed decision-making.

Thank you to everyone who joined the discussion, and to our hosts in Singapore for spotlighting Nordic RWE capabilities on a global stage.