In May 2024, the Council for International Organizations of Medical Sciences (CIOMS) published its much anticipated consensus report on Real-world data and real-world evidence in regulatory decision making. This webinar will introduce and explain the main concepts of this report. Real-world data — for example data from electronic health records and registries — are increasingly used to complement clinical trial data to support safety and efficacy claims for medicines. The report informs discussions about the use of real-world data and real-world evidence for regulatory and health care decision making, including decisions to make a product available for use (authorisation), to cover the costs of its use (reimbursement), and to use a product for a particular patient (clinical use). This webinar is intended for medicinal product regulators, healthcare payers, health care and medicinal products industries, researchers, bioethicists, patients and health care professionals.

https://doi.org/10.56759/kfxh6213