Chief Operating Officer Pearl Pathways, part of Versiti Clinical Trial Services
Precision medicine is reshaping the future of healthcare by tailoring treatments to specific patient populations based on genetic, biomarker, and phenotypic data. This session will provide a global perspective on regulatory strategies to support the development and approval of precision therapies and companion diagnostics. Attendees will gain practical insights into navigating region-specific requirements (e.g., FDA, EMA, PMDA), leveraging expedited pathways, and aligning drug and diagnostic development. The session will also highlight emerging trends, challenges, and regulatory innovations enabling access to personalized treatments worldwide.
Learning Objectives:
Identify key regulatory considerations for the global development and approval of precision medicines and companion diagnostics.
Compare and contrast regulatory pathways and expectations across major global markets, including the U.S., EU, and Asia-Pacific regions.
Apply strategic approaches to align therapeutic and diagnostic development timelines to meet regulatory expectations for co-development and approval.
