Nicole Chaves Petronzi
Senior Director, Global Regulatory Affairs Diagnostics Eli Lilly & Co.
Nicole Chaves Petronzi is Senior Director of Global Regulatory Affairs Diagnostics at Lilly. With extensive experience in in-vitro diagnostics and pharmaceutical regulatory strategy, Nicole has led global initiatives to implement the EU IVDR and harmonize compliance across multiple markets. Her work focuses on integrating diagnostics into pharmaceutical development, driving collaboration between Regulatory Affairs, Quality, Clinical, and Laboratory teams to accelerate innovation and patient access. Nicole is recognized for her ability to navigate complex regulatory landscapes and transform compliance into a strategic advantage for diagnostics in pharma.
Seminars
- At what stage should the diagnostic partner ideally be involved to ensure technical and regulatory alignment without slowing drug development?
- What does an ideal collaboration model look like under IVDR, balancing innovation speed with compliance?
- Can pharma use any IVD within its drug trial framework?
- Who should take the lead, and the regulatory accountability, in a combined study?
- The evolution of the Dx team in a pharma company
- How IVDR prompted deeper integration between Regulatory Affairs, Quality, Clinical, and Laboratory teams
- Which changes to the IVDR could streamline clinical trials in the EU