Navigate Global Regulatory Changes, Reimbursement & Policy Challenges to De-Risk Submissions, Align Strategies for Timely Patient Access to Safe & Effective Companion Diagnostic Tests Globally

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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.

Who Attended in June?

2024 Expert Speakers Included


“I am looking forward to a deep-dive into the recent developments in the global CDx regulatory landscape and to brainstorming ways to collaborate to develop streamlined processes across the regions to bring novel precision medicines to patients faster.”

Director of Regulatory Affairs, Pfizer

“The agenda was very well thought out and the networking event was very well attended.”

Expert speaker from parallel event featured in CDx portfolio

“I believe being able to share my experiences in regulatory, will help improve how we make decisions and what improvements can be made.”


“Outstanding speakers panel and audience. Great organization and cares about the details.”

CDx Boston Attendee, Senior Director, Monte Rosa Therapeutics

“Excellent that important stakeholders for CDx were brought together, no other conference achieves this in a similar manner”

Scientific-Regulatory Expert Targeted & Personalised Biomedicines, CDx Boston Attendee Paul-Ehrlich-Institute

Our 2024 Partners

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