Wendy Valenius
Senior Manager, Regulatory Affairs Diagnostics Pfizer
Seminars
Wednesday 1st April 2026
From Combined Trial Regulatory Requirements to Strategic Efficiency: Driving Innovation & Collaboration for CDx Success
12:00 pm
- Navigating Crossover Regulatory Frameworks, aligning clinical trial design with EU IVDR, EU CTR, UK MDR, and emerging regulations like the EU AI Act.
- Collaboration and Innovation Opportunities, how cross-functional & multidisciplinary partnerships can drive adaptive strategies across evolving regulatory landscapes.
- Current discourse and relevant stakeholders shaping CDx/precision medicine policies in the EU/EEA region
