Webinar
Navigating IVDR: Challenges and Strategies for Clinical Trial Assay Development and Regulatory Submissions
Speakers:
-
Pamela Swatkowski, Vice President of Global Regulatory Affairs
- Rachel O’Leary, Regulatory Affairs Project Manager
Topics in this presentation include:
- Insights into the IVDR submission process
- Knowledge and strategies on overcoming challenges, ensuring compliance and streamlining the path from assay development to successful submission
- Information on how to properly navigate the IVDR landscape and ensuring that clinical trial assays have the best chance of approval