In Vitro Diagnostic Regulatory & Reimbursement Conference

Guidance for efficient regulatory pathways, compliance and clinical research, exploring health economics and cost-value relationships for the IVD industry.

September 29-30 2008
Baltimore, MD

IVD tests are essential to the practice of health care worldwide: reports estimate two thirds of medical decisions involve a diagnostic test. With R&D expenses rising for new methodologies, payer perspectives are of increasing importance. This meeting will discuss health economics and its’ role in the value of diagnostics as well as market access issues, reimbursement, opportunities and risks for innovative products. Developing a forum to discuss the emerging challenges for diagnostic executives while providing strategic methods in areas which have been identified as critical concerns for the industry.

This will be a two-track forum focusing on regulatory, market access, and reimbursement strategies.

Conference Program Will Include:

Regulatory Pathways and Best Practices for Approval

Sally A. Hojvat, PhD
Director of Microbiology Devices
Office of In Vitro Diagnostic Device & Evaluation
CDRH, FDA

Compliance in IVD Clinical Trials and Bioresearch Monitoring

Michael Marcarelli
Director, Division of Bioresearch Monitoring
Office of Compliance
CDRH, FDA

Reimbursement and Coverage Policy for IVD
Bruce Quinn, MD, PhD
Senior Health Policy Specialist
Former Contractor Medical Director for the California Medicare Part B program
Foley Hoag LLP

Clinical Laboratories Influence on Technologies Acceptance

Myla Lai-Goldman, M.D.
Executive Vice President, Chief Medical Officer
Laboratory Corporation of America, Holdings

And many more...

To request full conference agenda and registration details:
Paul Hernandez, Marketing Manager
PHernandez@Q1productions.com
312-602-9684