Uniting All Regulatory Stakeholders Navigating the Complex, Ever-Evolving Global Landscape

There is a crucial need to add clarity to companion diagnostic (CDx) regulation; from IVDR in Europe, to LDT regulation in the US, to complicated reimbursement dynamics in APAC, confusing and impractical regulatory requirements are slowing the momentum of clinical trials and preventing patients with unmet access to best-in-class drugs.

Enter the inaugural World CDx Regulatory Affairs & Policy Summit. This 2024 event was the pioneering platform singularly focused on uniting regulatory experts, payers, policymakers, drug developers and diagnostic providers to address key challenges, form alliances and outline future policy and strategy directions. The goal? A streamlined approach to regulatory bodies to allow patients timely access to diagnostic tests globally.

Gathering experts from USA, Europe and APAC, this forum was the opportunity to be in the room with Directors, VPs, and SVPs from Regulation, Policy, Reimbursement, Companion Diagnostics at Merck, Pfizer, Sanofi and more. We joined them in a mission to harmonize and align requirements across regions through new policies, secure reimbursement and achieve global market access faster.