The 21st Century Cures Act highlights the importance of using real-world evidence (RWE) and the ways in which it can be used for regulatory decision making. This webinar will break down the current and future role of RWE for regulatory purposes, including:
- Understanding what constitutes quality in RWD and generating RWE from research-grade data
- Considerations with using data, modeling and more to support clinical studies and to develop registries for RWE for chronic diseases, rare diseases, and medical devices
- Opportunities for using RWE for post-marketing commitments, label expansion, and other regulatory requirements
Join Dr. Rich Gliklich, CEO of OM1, for this event.