Real world evidence is increasingly important for companies seeking to demonstrate device performance without the time and expense of extensive clinical trials. This webinar will explore how to effectively use real-world evidence in regulatory submissions to accelerate product approvals and meet post-market surveillance requirements.
Learning Objectives:
- Summarize recent regulatory guidance pertaining to the use of RWE in regulatory submissions.
- Discuss why RWE is valuable for your regulatory strategies from both a cost and time savings perspective.
- Explain potential challenges (and solutions) when using RWE to support safety and performance of your device.
- Identify strategies for integrating RWE into regulatory submissions using case studies and recent examples encountered by our Criterion Edge team.
Who is this for:
- Regulatory Affairs
- Chief Medical Officers
- Medical & Scientific Writers
