ON-DEMAND Webinar
Navigating IDE and IVDR Requirements in Drug Development
Now Streaming On-Demand
As drug products and clinical trial designs become increasingly complex, understanding when and how IDE (Investigational Device Exemption) and IVDR (In Vitro Diagnostic Medical Device Regulation) requirements apply is essential for successful development and regulatory approval.
In this on-demand webinar, experts from BioAgilytix share strategies for navigating global regulatory expectations. Drawing on real-world case studies, the discussion highlights how early planning and cross-functional alignment can help mitigate risk, streamline timelines, and facilitate regulatory success.
.
What You’ll Learn:
- When and why bioanalytical assays may be classified as IVDs
- Key requirements for IDE in the US
- Pathways to compliance with the EU IVDR
- How to deploy assays for clinical trial enrollment while minimizing regulatory risk and delay
- Insights from real-world case studies and regulatory interactions to accelerate IDE/IVDR readiness
Our experts will discuss lessons learned from their experiences and offer insight into the multiple stages of specific assays including critical reagents, regulatory standards, assay formats and timelines.
- Luke Armstrong, PhD, Associate Director/Bioanalytical Project Manager
- Amanda Hays, PhD, Scientific Officer
- Marco Klinge, PhD, Associate Director of Bioanalytical Operations
- Robert Nelson, PhD, Scientific Officer
- Natalie Smith, PhD, HCLD(ABB), CLIA Laboratory Director
- Will Williams, PhD, MS, Senior Director of Lab Operations
Share this Resource
