Overview

WP2 bridges the gap between commercial innovation and regulatory approval. We work with industry partners to streamline the certification and accreditation process for new pharmacogenomic assays. We work with industry partners to streamline the certification and accreditation process for pharmacogenomic medical devices.

Key Objectives

• Gap Analysis: Conducting comprehensive reviews of current industry and regulatory hurdles.
• Regulatory Portal: Designing a central hub to facilitate guidance and streamline testing approval.
• Assay Accreditation: Defining efficient pathways for commercial assay certification.

Related Resources

• About CERSI-PGx
• Regulatory Science and Pharmacogenomics

Leads